SentenceSentimentTitleUrlDate
The Trump administration in September said the Food and Drug Administration was working on a guidance that would lead to a ban of all ecigarette flavors aside from tobacco flavoring NegativeWASHINGTON U.S. President Donald Trump said on Monday he will be meeting with vaping industry representatives as his administration considers tightening ecigarette regulations amid a nationwide outbreak of vapingrelated injuries and deaths http://www.reuters.com/news/health/article/us-health-vaping-trump/trump-to-meet-with-vaping-industry-as-he-mulls-tighter-regulation-idUSKBN1XL1SP2019-11-12
The U.S. Food and Drug Administration on Monday declined to approve Lipocine Incs oral drug to treat a condition that results in lower production of male sex hormone for the third time sending the drug developers shares down NegativeThe U.S. Food and Drug Administration on Monday declined to approve Lipocine Incs oral drug to treat a condition that results in lower production of male sex hormone for the third time sending the drug developers shares down http://www.reuters.com/news/health/article/us-lipocine-fda/fda-rejects-lipocines-testosterone-drug-for-third-time-idUSKBN1XL1H42019-11-12
The drugmaker added it was discussing with the Food and Drug Administration the dataset that would be required for U.S. approval PositiveJohnson Johnsons applications are supported by data from over 10 studies that have tested the regimen in adults and children the company said http://www.reuters.com/news/health/article/us-johnson-johnson-ebola/johnson-johnson-files-for-european-approval-of-ebola-vaccine-idUSKBN1XH1J22019-11-08
Stephen Hahn chief medical executive of the University of Texas MD Anderson Cancer Center to lead the Food and Drug Administration the White House said on Friday NegativeU.S. President Donald Trump plans to nominate Dr http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-healthcare-fda/trump-nominates-md-anderson-oncologist-as-u-s-fda-commissioner-idUSKBN1XB4WU2019-11-02
NEW YORK The U.S. Food and Drug Administration on Friday downplayed the risk caused by contamination of the already recalled popular heartburn drug Zantac and said its tests suggest it does not cause carcinogens to form after ingestion by patients NegativeNEW YORK The U.S. Food and Drug Administration on Friday downplayed the risk caused by contamination of the already recalled popular heartburn drug Zantac and said its tests suggest it does not cause carcinogens to form after ingestion by patients http://www.reuters.com/news/health/article/us-fda-heartburn-zantac/fda-downplays-risks-from-already-recalled-heartburn-drug-zantac-idUSKBN1XB4ZO2019-11-02
The U.S. Food and Drug Administration on Wednesday approved Biogen Incs new oral drug to treat multiple sclerosis offering the drugmaker some relief as its core franchise faces patent challenges PositiveThe U.S. Food and Drug Administration on Wednesday approved Biogen Incs new oral drug to treat multiple sclerosis offering the drugmaker some relief as its core franchise faces patent challenges http://www.reuters.com/news/health/article/us-biogen-fda/small-relief-for-biogen-in-ms-drug-approval-idUSKBN1X91CB2019-10-31
Johnson Johnson said on Tuesday that 15 new tests found no asbestos in a bottle of baby powder that the U.S. Food and Drug Administration says tested positive for trace amounts of asbestos a finding the agency stands by NegativeJohnson Johnson said on Tuesday that 15 new tests found no asbestos in a bottle of baby powder that the U.S. Food and Drug Administration says tested positive for trace amounts of asbestos a finding the agency stands by http://www.reuters.com/news/ushttps://www.reuters.com/article/us-johnson-johnson-talc/jj-says-new-tests-find-no-asbestos-in-same-baby-powder-bottle-that-sparked-recall-idUSKBN1X82FP2019-10-30
NEW YORK As a private investor former U.S. Food and Drug Administration Commissioner Scott Gottlieb is focused on an area where few have found success in recent developing new antibiotics PositiveNEW YORK As a private investor former U.S. Food and Drug Administration Commissioner Scott Gottlieb is focused on an area where few have found success in recent developing new antibiotics http://www.reuters.com/news/health/article/us-healthcare-gottlieb-investing/ex-fda-chief-gottlieb-sees-investment-opportunity-in-unloved-antibiotics-idUSKBN1X82LR2019-10-30
NEW YORK The U.S. Food and Drug Administration is investigating whether the popular heartburn drug Zantac causes carcinogens to form in the bodies of users in an effort to fully understand the risks posed by the already recalled drug the agencys spokesman said on Thursday NegativeNEW YORK The U.S. Food and Drug Administration is investigating whether the popular heartburn drug Zantac causes carcinogens to form in the bodies of users in an effort to fully understand the risks posed by the already recalled drug the agencys spokesman said on Thursday http://www.reuters.com/news/health/article/us-fda-heartburn-zantac/fda-investigating-whether-zantac-causes-carcinogens-to-form-in-users-idUSKBN1X32NA2019-10-25
The U.S. Food and Drug Administration said on Wednesday that alternatives to popular heartburn drug Zantac and its generic versions known chemically as ranitidine have not been found to contain the probable cancercausing impurity that ranitidine has been linked to NegativeThe U.S. Food and Drug Administration said on Wednesday that alternatives to popular heartburn drug Zantac and its generic versions known chemically as ranitidine have not been found to contain the probable cancercausing impurity that ranitidine has been linked to http://www.reuters.com/news/ushttps://www.reuters.com/article/us-fda-heartburn/u-s-fda-says-carcinogen-not-found-in-alternatives-of-zantac-and-its-generics-idUSKBN1X22V32019-10-24
A rival technology which heats but does not burn tobacco has been authorized by the U.S. Food and Drug Administration and has avoided much of the recent regulatory crackdown globally PositiveBut countries around the world have been pulling electronic cigarette products from markets and restricting advertising as vaping faces increased scrutiny http://www.reuters.com/news/health/article/us-health-vaping-southkorea/south-korea-warns-of-serious-risk-from-vaping-considers-sales-ban-idUSKBN1X205E2019-10-24
Biogen said it had met with the Food and Drug Administration twice once in June and again on Monday to discuss the data PositiveFiling with U.S. regulators could potentially bring back to life a drug that had been completely left for RBC Capital Markets analyst Brian Abrahams wrote in a note http://www.reuters.com/news/health/article/us-biogen-alzheimers/biogen-resurrects-alzheimers-drug-shares-jump-27-idUSKBN1X116D2019-10-23
NEW YORK The U.S. Food Drug Administration said on Friday that it found that a sample from one lot of Johnson Johnsons baby powder contained chrysotile fibers a type of asbestos confirming test results the company disclosed earlier on Friday NegativeNEW YORK The U.S. Food Drug Administration said on Friday that it found that a sample from one lot of Johnson Johnsons baby powder contained chrysotile fibers a type of asbestos confirming test results the company disclosed earlier on Friday http://www.reuters.com/legal/article/us-johnson-johnson-talc-fda/fda-alerts-consumers-of-jj-baby-powder-recall-says-it-stands-by-tests-idUSKBN1WX2E32019-10-19
The Food and Drug Administrations decision on the cotton plant developed by Texas University scientists means it is allowed as food for people and all types of animals PositiveWASHINGTON U.S. regulators on Friday gave the green light for genetically modified cotton to be used for human consumption paving the way for a proteinpacked new food source edible cottonseed that tastes a bit like chickpeas that its developers said could help tackle global malnutrition http://www.reuters.com/news/ushttps://www.reuters.com/article/us-science-cottonseed/u-s-regulators-allow-genetically-modified-cotton-as-human-food-source-idUSKBN1WQ2J12019-10-12
The U.S. Food and Drug Administration said on Friday it had approved Eli Lilly and Cos migraine drug Reyvow NegativeThe U.S. Food and Drug Administration said on Friday it had approved Eli Lilly and Cos migraine drug Reyvow http://www.reuters.com/news/health/article/us-lilly-fda/eli-lillys-migraine-treatment-wins-u-s-fda-approval-idUSKBN1WQ2GZ2019-10-12
The U.S. Food and Drug Administration on Monday approved a bonebuilding drug from Pfenex Inc to treat osteoporosis in certain patients at high risk for fractures giving the company its first commercial product NegativeThe U.S. Food and Drug Administration on Monday approved a bonebuilding drug from Pfenex Inc to treat osteoporosis in certain patients at high risk for fractures giving the company its first commercial product http://www.reuters.com/news/sciencehttps://www.reuters.com/article/us-pfenex-fda/fda-approves-pfenexs-osteoporosis-therapy-idUSKBN1WM0Z32019-10-08
ZURICH Novartis has received approval from the U.S. Food and Drug Administration for its Beovu drug to treat a cause of vision loss the Swiss pharmaceuticals company said on Tuesday NegativeZURICH Novartis has received approval from the U.S. Food and Drug Administration for its Beovu drug to treat a cause of vision loss the Swiss pharmaceuticals company said on Tuesday http://www.reuters.com/news/health/article/us-novartis-beovu-approval/novartis-gets-u-s-approval-for-eye-drug-beovu-idUSKBN1WN0FB2019-10-08
It would also allow the U.S. Food and Drug Administration to lower this cap and give the agency the flexibility to regulate the design and function of ecigarettes NegativeA U.S. lawmaker on Monday introduced a bill that seeks to regulate ecigarette makers by capping the amount of nicotine in the vapes they manufacture to make them less addictive http://www.reuters.com/news/health/article/us-usa-vaping-lawmakers/democrat-lawmaker-introduces-bill-to-cap-nicotine-content-in-vapes-idUSKBN1WM1VW2019-10-08
Judy McMeekin an official with the U.S. Food and Drug Administration said the agency had collected more than 440 vaping product samples from 18 states for testing so far NegativeU.S. health officials on Thursday reported 18 deaths due to a mysterious lung illness linked to ecigarettes and other vaping products and said the number of confirmed and probable cases of the condition now exceeds 1000 http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-vaping-cdc/u-s-vaping-related-deaths-rise-to-18-illnesses-surpass-1000-cdc-idUSKBN1WI2B42019-10-04
The U.S. Food and Drug Administration and international health authorities are investigating the safety of Zantac heartburn medicine also sold generically as ranitidine after finding a probable cancercausing impurity NegativeThe U.S. Food and Drug Administration and international health authorities are investigating the safety of Zantac heartburn medicine also sold generically as ranitidine after finding a probable cancercausing impurity http://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-health-fda-heartburn-timeline/timeline-popular-heartburn-medicine-zantac-pulled-off-store-shelves-idUSKBN1WH2K72019-10-03
The move comes after the U.S. Food and Drug Administration warned that some of the pills contained small amounts Nnitrosodimethylamine which the regulator says is a probable human NegativeDHAKA Bangladeshs drug regulatory authority on Sunday issued a ban on sales of popular heartburn drug ranitidine while it investigates a potential cancercausing substance in the drug http://www.reuters.com/news/health/article/us-bangladesh-ranitidine/bangladesh-bans-heartburn-drug-ranitidine-over-cancer-fears-idUSKBN1WE0J92019-09-30
CVS Health Corp said on Saturday it will discontinue sales the popular Zantac heartburn treatment and its own generic ranitidine products from its pharmacies after traces of a known carcinogen were found in some of the products by the U.S. Food and Drug Administration NegativeCVS Health Corp said on Saturday it will discontinue sales the popular Zantac heartburn treatment and its own generic ranitidine products from its pharmacies after traces of a known carcinogen were found in some of the products by the U.S. Food and Drug Administration http://www.reuters.com/news/health/article/us-cvs-health-heartburn/cvs-suspends-sales-of-zantac-brand-and-generic-heartburn-drug-during-safety-review-idUSKBN1WD0P02019-09-30
Claims that products are healthier or safer than traditional cigarettes must be approved by the U.S. Food and Drug Administration Krishnamoorthi said NegativeWASHINGTON A U.S. House panel sent letters to four ecigarette companies asking them to stop all print broadcast and digital advertising of their products in the United States the same day as marketleader Juul said it would pull its ads the panel said on Thursday http://www.reuters.com/news/mediahttps://www.reuters.com/article/us-ecigarettes-advertising/u-s-house-panel-asks-e-cigarette-companies-to-cease-advertising-idUSKBN1WB1YC2019-09-27
The iQOS which heats but does not burn tobacco is a rival nonsmoking technology and crucially has been authorized by the U.S. Food and Drug Administration NeutralThe chief executive of ecigarette maker Juul stepped down on Wednesday as merger talks between its biggest investor Altria and Philip Morris collapsed in the face of a regulatory backlash against vaping that could reshape the industry http://www.reuters.com/finance/article/us-altria-m-a-philipmorris/juul-boss-exits-in-vaping-crisis-as-philip-morris-altria-axe-merger-talks-idUSKBN1WA1DY2019-09-26
On Wednesday the acting commissioner of the Food and Drug Administration will appear before a House Energy and Commerce subcommittee and be asked about the public health threats of ecigarettes NegativeWASHINGTON Hundreds more Americans have been sickened by a severe vapingrelated illness with the official tally set to be updated on Thursday according to a U.S. health official speaking at a congressional hearing on Tuesday http://www.reuters.com/politicshttps://www.reuters.com/article/us-health-vaping-congress/u-s-cdc-expects-hundreds-more-cases-of-vaping-related-illness-idUSKBN1W913P2019-09-25
The U.S. Food and Drug Administration on Friday issued a proposed rule for ecigarette makers requiring them to maintain records related to the legal marketing status of their products PositiveThe U.S. Food and Drug Administration on Friday issued a proposed rule for ecigarette makers requiring them to maintain records related to the legal marketing status of their products http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-vaping-fda/fda-proposes-rule-over-record-keeping-for-vape-makers-idUSKBN1W51L72019-09-21
Subsys contains fentanyl an opioid 100 times stronger than morphine and the U.S. Food and Drug Administration has only approved it to treat pain in cancer patients NegativeDrugmaker Insys Therapeutics Inc on Thursday won court approval to sell its flagship fentanyl spray to a buyer who agreed to only market the drug for use by cancer patients in response to concerns about the products role in fueling the opioid epidemic http://www.reuters.com/legal/article/us-insys-opioids-bankruptcy/drugmaker-insys-wins-bankruptcy-court-approval-to-sell-off-opioid-idUSKBN1W42KY2019-09-20
An independent expert panel to the U.S. Food and Drug Administration on Wednesday recommended approval of GlaxoSmithKline Plcs overthecounter nicotine oral spray that aims to help smokers quit their addiction PositiveAn independent expert panel to the U.S. Food and Drug Administration on Wednesday recommended approval of GlaxoSmithKline Plcs overthecounter nicotine oral spray that aims to help smokers quit their addiction http://www.reuters.com/news/health/article/us-gsk-fda/gsks-over-the-counter-nicotine-oral-spray-gets-fda-panel-backing-idUSKBN1W32V22019-09-19
ZURICH Roche has won the U.S. Food and Drug Administrations breakthrough therapy tag for its drug Gazyva in lupus nephritis the Swiss drugmaker said on Wednesday boosting its efforts to recycle the 2013approved lymphoma medicine for new indications PositiveZURICH Roche has won the U.S. Food and Drug Administrations breakthrough therapy tag for its drug Gazyva in lupus nephritis the Swiss drugmaker said on Wednesday boosting its efforts to recycle the 2013approved lymphoma medicine for new indications http://www.reuters.com/news/health/article/us-roche-lupus-nephritis/roche-bid-to-recycle-gayzva-for-lupus-nephritis-wins-fda-breakthrough-tag-idUSKBN1W30OW2019-09-18
JOHANNESBURG The U.S. Food and Drug Administration has approved Aspen Pharmacares hydroxyprogesterone caproate which is used to prevent preterm birth in pregnant women the South African drugmakers CEO said on Thursday NegativeJOHANNESBURG The U.S. Food and Drug Administration has approved Aspen Pharmacares hydroxyprogesterone caproate which is used to prevent preterm birth in pregnant women the South African drugmakers CEO said on Thursday http://www.reuters.com/places/africa/article/us-aspen-pharmacare-usa/aspens-drug-to-prevent-preterm-birth-approved-by-fda-idUSKCN1VX28Q2019-09-13
The U.S. Food and Drug Administration has approved Xeris Pharmaceuticals Incs glucagon therapy that aims to treat severely low sugar levels in diabetes patients the drugmaker said on Tuesday PositiveThe U.S. Food and Drug Administration has approved Xeris Pharmaceuticals Incs glucagon therapy that aims to treat severely low sugar levels in diabetes patients the drugmaker said on Tuesday http://www.reuters.com/news/health/article/us-xeris-fda/xeris-pharmas-low-blood-sugar-treatment-wins-fda-approval-idUSKCN1VV21T2019-09-11
The U.S. Food and Drug Administration warned Juul Labs Inc on Monday for marketing its ecigarettes as safer than traditional cigarettes the latest move by the agency to curb the use of vaping devices that have become extremely popular among teens NegativeThe U.S. Food and Drug Administration warned Juul Labs Inc on Monday for marketing its ecigarettes as safer than traditional cigarettes the latest move by the agency to curb the use of vaping devices that have become extremely popular among teens http://www.reuters.com/news/health/article/us-juul-fda-ecigarettes/juul-warned-by-fda-over-marketing-practices-idUSKCN1VU1OC2019-09-10
The results presented on Monday at the World Lung Conference on Lung Cancer in Barcelona will support Lillys application for U.S. Food and Drug Administration approval later this year PositiveEli Lilly and Cos LOXO292 a experimental cancer drug the company acquired in January as part of its billion takeover of Loxo Oncology shrank tumors in nearly of advanced lung cancer patients whose tumors carried specific abnormalities in the RET gene http://www.reuters.com/news/health/article/us-lilly-cancer-lung/lillys-targeted-ret-drug-shrinks-tumors-in-lung-cancer-trial-idUSKCN1VU0L42019-09-10
Amgen said the U.S. Food and Drug Administration has granted fast status to AMG510 for previously treated NSCLC with KRASG12C mutation NegativeAn experimental Amgen Inc drug that targets a specific genetic mutation reduced tumor size in around half of advanced lung cancer patients given the highest dose in a small earlystage trial the company said on Sunday http://www.reuters.com/news/health/article/us-amgen-cancer-amg510/amgen-drug-shrinks-lung-cancer-tumors-in-half-of-patients-study-idUSKCN1VT06O2019-09-09
Staff from health agencies including the U.S. Food and Drug Administration said they have not linked the illnesses to any specific ecigarette product or any particular substance in the ecigarettes NegativeA Los Angeles County resident has died from a lung illness possibly tied to vaping bringing the total number of such U.S. deaths to five health officials said on Friday http://www.reuters.com/news/health/article/us-health-vaping/los-angeles-county-resident-dies-of-lung-illness-fifth-u-s-death-possibly-tied-to-vaping-idUSKCN1VR26O2019-09-07
ZURICH Novartis has nabbed the U.S. Food and Drug Administrations breakthrough therapy designation for its experimental medicine capmatinib as it joins Pfizer in the race to treat a toughtotreat mutated lung cancer type PositiveZURICH Novartis has nabbed the U.S. Food and Drug Administrations breakthrough therapy designation for its experimental medicine capmatinib as it joins Pfizer in the race to treat a toughtotreat mutated lung cancer type http://www.reuters.com/news/health/article/us-novartis-breakthrough/novartis-joins-pfizer-with-fda-fast-track-tag-for-lung-cancer-hopeful-idUSKCN1VR0HG2019-09-06
The U.S. Food and Drug Administrations Orphan drug status comes with incentives including a period of marketing exclusivity to developers of rare disease treatments NegativeThe U.S. patent office will review patents on Alexion Pharmaceuticals Incs blood disorder treatment Soliris after Amgen Inc challenged them court filings showed on Friday http://www.reuters.com/legal/article/us-alexion-pharms-patent-amgen/patent-court-to-review-alexions-soliris-patents-on-amgen-challenge-idUSKCN1VK1NH2019-08-31
In April Philip Morris won approval from the U.S. Food and Drug Administration to sell iQOS in the United States NegativePhilip Morris and Altria see scope in consolidating their manufacturing operations to generate annual synergies of more than million according to the source http://www.reuters.com/finance/article/us-philip-morris-m-a-altria/philip-morris-and-altria-in-merger-talks-as-marlboro-fades-and-e-cigs-light-up-idUSKCN1VH1IN2019-08-28
AstraZeneca Plc said on Tuesday that the U.S. Food and Drug Administration has granted fast track status for the development of its diabetes drug Farxiga to prevent heart and kidney failure in patients with chronic kidney disease NegativeAstraZeneca Plc said on Tuesday that the U.S. Food and Drug Administration has granted fast track status for the development of its diabetes drug Farxiga to prevent heart and kidney failure in patients with chronic kidney disease http://www.reuters.com/news/health/article/us-astrazeneca-farxiga-fda/fda-gives-fast-track-status-to-astrazenecas-diabetes-drug-farxiga-idUSKCN1VH0HZ2019-08-28
Nabriva Therapeutics Plc on Monday priced an oral and injectable version of its antibiotic Xenleta which treats communityacquired pneumonia at more than per day after it received approval from the U.S. Food and Drug Administration NegativeNabriva Therapeutics Plc on Monday priced an oral and injectable version of its antibiotic Xenleta which treats communityacquired pneumonia at more than per day after it received approval from the U.S. Food and Drug Administration http://www.reuters.com/news/health/article/us-nabriva-fda/nabriva-prices-two-pneumonia-antibiotic-versions-at-over-200-per-day-idUSKCN1V91QQ2019-08-20
Sarepta Therapeutics Inc said on Monday the U.S. Food and Drug Administration declined to approve its newest treatment for Duchenne muscular dystrophy citing safety concerns including the risk of infection and kidney toxicity NegativeSarepta Therapeutics Inc said on Monday the U.S. Food and Drug Administration declined to approve its newest treatment for Duchenne muscular dystrophy citing safety concerns including the risk of infection and kidney toxicity http://www.reuters.com/news/health/article/us-sarepta-fda-duchenne/fda-declines-to-approve-sareptas-second-duchenne-treatment-idUSKCN1V91YI2019-08-20
Rozlytrek was approved by the U.S. Food and Drug Administration on Thursday to treat certain types of solid tumors which show NTRK fusions NeutralRoche Holding AG has priced its personalized cancer treatment Rozlytrek at about per month nearly half of the monthly price of a rival drug from Bayer AG and Eli Lilly and Co that was approved last year http://www.reuters.com/news/health/article/us-roche-hldg-fda-pricing/roche-cancer-treatment-priced-at-17050-a-month-lower-than-rival-vitrakvi-idUSKCN1V61G82019-08-19
VIENNA An unnamed Novartis executive sold 925400 Swiss francs worth of shares less than three weeks before the U.S. Food and Drug Administration announced data from tests of its gene therapy Zolgensma had been manipulated NegativeVIENNA An unnamed Novartis executive sold 925400 Swiss francs worth of shares less than three weeks before the U.S. Food and Drug Administration announced data from tests of its gene therapy Zolgensma had been manipulated http://www.reuters.com/finance/article/us-novartis-share-sale/novartis-executive-sold-shares-before-drug-data-manipulation-made-public-idUSKCN1V80IY2019-08-18
The U.S. Food and Drug Administration on Friday approved Celgene Corps Inrebic to treat certain rare forms of bone marrow cancer called myelofibrosis making it the second approved drug to treat the disease NegativeThe U.S. Food and Drug Administration on Friday approved Celgene Corps Inrebic to treat certain rare forms of bone marrow cancer called myelofibrosis making it the second approved drug to treat the disease http://www.reuters.com/news/health/article/us-celgene-fda/fda-approves-celgenes-bone-marrow-cancer-treatment-idUSKCN1V61BS2019-08-18
The U.S. Food and Drug Administration has approved TB Alliances treatment for drugresistant tuberculosis as part of a threedrug combination regimen called BPaL the notforprofit said on Wednesday NeutralThe U.S. Food and Drug Administration has approved TB Alliances treatment for drugresistant tuberculosis as part of a threedrug combination regimen called BPaL the notforprofit said on Wednesday http://www.reuters.com/news/health/article/us-tb-alliance-fda/u-s-fda-approves-tb-alliances-treatment-for-drug-resistant-tuberculosis-idUSKCN1V41UU2019-08-15
The U.S. Food and Drug Administration has told four companies to remove 44 of their flavored eliquid and hookah tobacco products that do not have the required approval for sale in the U.S. the agency said on Thursday NegativeThe U.S. Food and Drug Administration has told four companies to remove 44 of their flavored eliquid and hookah tobacco products that do not have the required approval for sale in the U.S. the agency said on Thursday http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-vaping/fda-tells-four-firms-to-stop-selling-flavored-e-cigarette-hookah-products-idUSKCN1UY1U22019-08-09
NEW YORK The U.S. Food and Drug Administration said on Tuesday that some data from early testing of Novartis more than million gene therapy Zolgensma was manipulated but the agency believes the treatment should remain on the market NegativeNEW YORK The U.S. Food and Drug Administration said on Tuesday that some data from early testing of Novartis more than million gene therapy Zolgensma was manipulated but the agency believes the treatment should remain on the market http://www.reuters.com/legal/article/us-usa-fda-novartis/u-s-fda-says-some-data-testing-novartis-2-million-gene-therapy-was-manipulated-idUSKCN1UW2382019-08-07
The EUs latest approval for Dupixent also comes after the U.S. Food Drug Administration regulator in June approved Dupixent to treat nasal polyps PositivePARIS The Dupixent product developed by French healthcare company Sanofi and its U.S. partner Regeneron has won regulatory approval in Europe for moderatetosevere cases of eczema in adolescents the companies said http://www.reuters.com/news/health/article/us-sanofi-regeneron-dupixent/eu-approves-sanofi-regenerons-dupixent-for-adolescent-eczema-cases-idUSKCN1UW0D02019-08-06
TEL AVIV Israels Nobio Ltd said on Monday it received approval from the U.S. Food and Drug Administration to market its antibacterial composite designed to remain in the teeth for decades PositiveTEL AVIV Israels Nobio Ltd said on Monday it received approval from the U.S. Food and Drug Administration to market its antibacterial composite designed to remain in the teeth for decades http://www.reuters.com/news/health/article/us-health-nobio-regulator/nobio-gets-fda-approval-for-anti-bacterial-dental-fillings-idUSKCN1UV17P2019-08-06
Finlands Orion and Germanys Bayer said on Wednesday the U.S. Food and Drug Administration had approved prostate cancer drug daroluramide which the two companies have been developing together PositiveFinlands Orion and Germanys Bayer said on Wednesday the U.S. Food and Drug Administration had approved prostate cancer drug daroluramide which the two companies have been developing together http://www.reuters.com/news/health/article/us-bayer-orion-usa/orion-bayer-prostate-cancer-drug-gets-fda-approval-idUSKCN1UQ0OM2019-07-31
At the time it was Merck Cos immunotherapy Keytruda that won approval from the U.S. Food and Drug Administration for this treatment approach which is also known as tumouragnostic NegativeEuropes drug regulator has recommended approving Bayers Vitrakvi putting the medicine on track to become the first in Europe to tackle tumours with a specific genetic mutation regardless of where in the body the disease started http://www.reuters.com/news/health/article/us-bayer-vitrakvi-ema/bayer-in-frame-to-win-first-eu-nod-for-high-precision-cancer-drug-idUSKCN1UL1H02019-07-27
The U.S. Food and Drug Administration has approved Merck Co Incs combination treatment for complicated forms of urinary tract and abdominal infections the drugmaker said on Wednesday NegativeThe U.S. Food and Drug Administration has approved Merck Co Incs combination treatment for complicated forms of urinary tract and abdominal infections the drugmaker said on Wednesday http://www.reuters.com/news/health/article/us-merck-co-fda/mercks-treatment-for-urinary-abdominal-infections-gets-fda-approval-idUSKCN1UC19W2019-07-18
A U.S. federal judge on Friday ordered the Food and Drug Administration to impose a 10month deadline for the submission of ecigarette applications turning the screws on companies like Juul Labs Inc whose products have come under intense scrutiny for their popularity among teenagers NegativeA U.S. federal judge on Friday ordered the Food and Drug Administration to impose a 10month deadline for the submission of ecigarette applications turning the screws on companies like Juul Labs Inc whose products have come under intense scrutiny for their popularity among teenagers http://www.reuters.com/legal/article/us-usa-vaping/u-s-federal-judge-orders-fda-to-implement-10-month-deadline-for-e-cig-applications-idUSKCN1U72GR2019-07-15
The U.S. Food and Drug Administration said on Monday three deaths had been reported related to Edwards Lifesciences Corps recall of some of its heart devices NegativeThe U.S. Food and Drug Administration said on Monday three deaths had been reported related to Edwards Lifesciences Corps recall of some of its heart devices http://www.reuters.com/news/health/article/us-edwards-lifesci-recall/fda-says-three-deaths-related-to-edwards-lifesciences-recalled-heart-devices-idUSKCN1TW3RE2019-07-02
Pfizer Inc said on Friday that the U.S. Food and Drug Administration had approved its biosimilar to Roche Holding AGs blockbuster cancer treatment Avastin NegativePfizer Inc said on Friday that the U.S. Food and Drug Administration had approved its biosimilar to Roche Holding AGs blockbuster cancer treatment Avastin http://www.reuters.com/news/health/article/us-pfizer-fda/pfizers-avastin-biosimilar-wins-fda-approval-idUSKCN1TT1Q92019-06-29
The U.S. Food and Drug Administration said on Thursday that certain insulin pumps of Medtronic Plc were being recalled due to a potential risk of them being hacked NegativeThe U.S. Food and Drug Administration said on Thursday that certain insulin pumps of Medtronic Plc were being recalled due to a potential risk of them being hacked http://www.reuters.com/news/technology/article/us-medtronic-cyber/fda-warns-of-cybersecurity-risk-to-certain-medtronic-insulin-pumps-idUSKCN1TS2YW2019-06-28
The U.S. Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals Inc and Sanofi SAs drug Dupixent to treat nasal polyps marking the third major use for the injectable medicine NegativeThe U.S. Food and Drug Administration on Wednesday approved Regeneron Pharmaceuticals Inc and Sanofi SAs drug Dupixent to treat nasal polyps marking the third major use for the injectable medicine http://www.reuters.com/news/health/article/us-regeneron-pharms-fda-sanofi-fr/fda-approves-expanded-label-for-regeneron-sanofis-dupixent-idUSKCN1TR2RU2019-06-27
The San Francisco Board of Supervisors approved the ordinance on Tuesday banning the sale and distribution of ecigarettes until they have approval from the U.S. Food and Drug Administration NegativeSan Francisco will become the first major city in the United States to ban the sale of ecigarettes as officials look to control the rapid uptick in teenage use of nicotine devices made by companies such as Juul Labs Inc http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-sanfrancisco-ecigarettes/juul-loses-home-turf-as-san-francisco-bans-e-cigarette-sales-idUSKCN1TQ2YL2019-06-26
Japans Daiichi Sankyo Co said on Friday the U.S. Food and Drug Administration has declined to approve its drug quizartinib as a treatment for adults with a type of blood cancer NegativeJapans Daiichi Sankyo Co said on Friday the U.S. Food and Drug Administration has declined to approve its drug quizartinib as a treatment for adults with a type of blood cancer http://www.reuters.com/places/japan/article/us-daiichi-sankyo-fda/fda-declines-to-approve-daiichi-sankyos-blood-cancer-treatment-idUSKCN1TM1IQ2019-06-22
Addyi was approved under intense pressure from advocacy groups despite a review by scientists at the Food and Drug Administration that deemed it minimally effective and possibly unsafe NegativeThe U.S. drug regulator on Friday approved Palatin Technologies and Amag Pharmaceuticals drug to restore sexual desire in premenopausal women the latest attempt to come up with a therapy that some have dubbed as female http://www.reuters.com/news/health/article/us-amag-fda/fda-approves-drug-for-loss-of-sexual-desire-in-women-idUSKCN1TM2OA2019-06-22
Mayzent was approved in March by the U.S. Food and Drug Administration for adults with relapsing forms of multiple sclerosis including active secondary progressive disease NegativeZURICH A U.S. group that reviews the value of medicines issued a critical report on Novartiss new multiple sclerosis drug Mayzent calling its list price far out of compared with its benefits for patients http://www.reuters.com/news/health/article/us-novartis-icer/u-s-group-says-novartis-ms-drug-price-out-of-line-with-benefit-idUSKCN1TM0H32019-06-21
June 13 The U.S. Food and Drug Administration said it can advance the date for the submission of ecigarette applications responding to a ruling that the agency had exceeded its authority by allowing ecigarettes to remain on the market until 2022 before companies applied for regulatory approval PositiveJune 13 The U.S. Food and Drug Administration said it can advance the date for the submission of ecigarette applications responding to a ruling that the agency had exceeded its authority by allowing ecigarettes to remain on the market until 2022 before companies applied for regulatory approval http://www.reuters.com/legal//www.reuters.com/article/usa-vaping/fda-proposes-shorter-deadline-for-e-cigarette-applications-idUSL4N23K3CR2019-06-14
IBM Merck and Walmart have been chosen for a U.S. Food and Drug Administration pilot program that will explore using blockchain technology to improve the security of prescription drug supply and distribution PositiveIBM Merck and Walmart have been chosen for a U.S. Food and Drug Administration pilot program that will explore using blockchain technology to improve the security of prescription drug supply and distribution http://www.reuters.com/legal/article/us-fda-blockchain/ibm-walmart-merck-in-blockchain-collaboration-with-fda-idUSKCN1TE1SA2019-06-14
The U.S. Food and Drug Administration requires autoinjector expiration dates to ensure that the devices never contain less than of the original dose of epinephrine the study team notes PositiveThe U.S. Food and Drug Administration requires autoinjector expiration dates to ensure that the devices never contain less than of the original dose of epinephrine the study team notes http://www.reuters.com/news/health/article/us-health-allergies-epinephrine/many-epinephrine-self-injectors-still-potent-long-after-expiration-date-idUSKCN1TE2OX2019-06-14
Catalyst Pharmaceuticals Inc which has come under fire for the high price tag on its rare disease drug on Wednesday sued the U.S. Food and Drug Administration to challenge the recent approval of a lowercost rival drug NegativeCatalyst Pharmaceuticals Inc which has come under fire for the high price tag on its rare disease drug on Wednesday sued the U.S. Food and Drug Administration to challenge the recent approval of a lowercost rival drug http://www.reuters.com/news/health/article/us-catalyst-pharms-fda-lawsuit/catalyst-pharma-sues-fda-over-approval-of-cheaper-rival-drug-idUSKCN1TD1L72019-06-13
The U.S. Food and Drug Administration on Tuesday carved out new recommendations for makers of ecigarettes or vapes including guidelines on how to address public health issues while designing their products NegativeThe U.S. Food and Drug Administration on Tuesday carved out new recommendations for makers of ecigarettes or vapes including guidelines on how to address public health issues while designing their products http://www.reuters.com/news/health/article/us-fda-vaping/fda-unveils-new-guidelines-for-e-cigarette-makers-idUSKCN1TC1RB2019-06-12
The U.S. Food and Drug Administration and the Federal Trade Commission on Friday issued warning letters to four flavored eliquid product makers stepping up pressure on firms using social media influencers to promote their products NegativeThe U.S. Food and Drug Administration and the Federal Trade Commission on Friday issued warning letters to four flavored eliquid product makers stepping up pressure on firms using social media influencers to promote their products http://www.reuters.com/news/health/article/us-usa-fda-ecigarettes/u-s-fda-warns-flavored-e-cigarette-makers-over-social-media-posts-idUSKCN1T81Z02019-06-08
Chinas National Health and Family Planning Commission and the China Food and Drug Administration which regulate the healthcare system did not immediately respond to requests for comment NegativeSAO PAULO The U.S. Securities and Exchange Commission is investigating Siemens AG Philips NV and General Electric Co for allegedly using local middlemen to negotiate bribes with Chinese government and hospital officials to sell medical equipment two U.S. sources with knowledge of the matter told Reuters http://www.reuters.com/places/brazil/article/us-brazil-corruption-sec-china-exclusive/exclusive-sec-probes-siemens-ge-philips-in-alleged-china-medical-equipment-scheme-idUSKCN1T51512019-06-05
NEW YORK Eli Lilly and Cos migraine treatment Emgality on Tuesday became the first drug to gain U.S. approval for decreasing the frequency of episodic cluster headache attacks the Food and Drug Administration said NegativeNEW YORK Eli Lilly and Cos migraine treatment Emgality on Tuesday became the first drug to gain U.S. approval for decreasing the frequency of episodic cluster headache attacks the Food and Drug Administration said http://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-lilly-emgality-approval/fda-approves-lillys-migraine-drug-as-first-ever-cluster-headache-treatment-idUSKCN1T52VP2019-06-05
Health Canadas decision is in contrast to public rulings and positions by other regulatory bodies around the world including the U.S. Food and Drug Administrations recent position Allergan said NegativeAllergan Plc said on Tuesday it will voluntarily recall and stop the sale of its Biocell textured breast implants in Canada after the countrys health agency suspended the companys licenses for the implants citing increased risk of cancer http://www.reuters.com/news/health/article/us-allergan-canada/allergan-to-recall-textured-breast-implants-in-canada-idUSKCN1SY2BX2019-05-29
The U.S. Food and Drug Administration last month ordered the two remaining companies selling transvaginal mesh Boston Scientific and Coloplast to halt sales of the product citing safety concerns NegativeNEW YORK A doctor and a surgical funding consultant were arrested on Friday on charges that they defrauded women into having unnecessary surgeries to remove transvaginal mesh implants in order to profit from settlements paid to the women by mesh manufacturers U.S. prosecutors in New York said http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-crime-surgicalmesh/doctor-medical-funder-charged-in-new-york-in-transvaginal-mesh-fraud-idUSKCN1SU2ES2019-05-25
The HB4 trait has been approved in Argentina and by the U.S. Food Drug Administration according to the companies NegativeSAO PAULO Brazils biosecurity agency CTNBio has approved a new soybean seed that combines technologies to make it resistant to drought and two widely used herbicides according to a statement on Friday from the companies that created the product http://www.reuters.com/places/brazil/article/us-brazil-soybeans/brazil-approves-new-soy-seed-that-resists-drought-two-herbicides-idUSKCN1SU2442019-05-25
The U.S. Food and Drug Administration said on Friday that it had approved Novartis AGs treatment in combination with a hormone therapy for postmenopausal women as well as for men with a form of advanced breast cancer PositiveThe U.S. Food and Drug Administration said on Friday that it had approved Novartis AGs treatment in combination with a hormone therapy for postmenopausal women as well as for men with a form of advanced breast cancer http://www.reuters.com/news/health/article/us-novartis-fda/novartis-breast-cancer-treatment-wins-fda-approval-idUSKCN1SU2AN2019-05-25
The Supreme Court will soon rule in another case that rests on whether a U.S. Food and Drug Administration approval preempts tort claims NeutralNEW YORK Bayer AG plans to argue that a billion jury award and thousands of U.S. lawsuits claiming its glyphosatebased weed killer Roundup causes cancer should be tossed because a U.S. regulatory agency said the herbicide is not a public health risk http://www.reuters.com/finance/article/us-bayer-glyphosate-lawsuit-appeals-anal/bayer-bets-on-silver-bullet-defense-in-roundup-litigation-experts-see-hurdles-idUSKCN1SM2R32019-05-17
Genus is also currently seeking approval from the U.S. Food and Drug Administration to commercialize the virusresistant pigs in the United States NegativeBEIJING British livestock genetics firm Genus agreed on Thursday to license its knowhow on virusresistant pigs to Beijing Capital Agribusiness Co Ltd which will seek regulatory approval for the pigs in the worlds biggest pork market http://www.reuters.com/innovation/article/us-china-genus-plc/genus-shares-surge-on-deal-to-market-gene-edited-pigs-in-china-idUSKCN1SM1212019-05-17
Brazils government has approved commercial use of GM cane and the U.S. Food and Drug Administration has ruled that it is safe to consume sugar made from that cane PositiveBEIJING Brazils agriculture minister will ask Chinese officials on Thursday to greenlight exports to the Asian nation of sugar made from genetically modified sugarcane which is expected to be widely used in Brazil in coming years http://www.reuters.com/places/brazil/article/us-china-brazil-trade/brazil-seeks-chinas-ok-for-genetically-modified-sugarcane-idUSKCN1SL2BM2019-05-16
Daiichi and the British drugmaker said they planned to seek approval for the drug with the U.S. Food and Drug Administration in the second half this year NeutralAn experimental breast cancer drug being developed by British drugmaker AstraZeneca and Japans Daiichi Sankyos met its main goal in a midstage study bolstering their position in a highly competitive oncology market http://www.reuters.com/places/japan/article/us-astrazeneca-breast-cancer-study/astrazeneca-daiichi-breast-cancer-treatment-shows-promise-in-latest-study-idUSKCN1SE0LJ2019-05-09
The U.S. Food and Drug Administration is expected to make a decision on the gene therapy by May 31 NeutralZURICH Novartis is confident it has adequate production capacity for its Zolgensma gene therapy should regulators this month approve the drug for multiple forms of the genetic disease spinal muscular atrophy the Swiss drugmaker said on Wednesday http://www.reuters.com/news/health/article/us-novartis-sma/novartis-confident-of-zolgensma-supply-calls-2-million-price-speculation-idUSKCN1SE23O2019-05-09
NEW YORK The U.S. Food and Drug Administration on Monday approved Pfizer Incs oral drug tafamidis to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy the U.S drugmaker said NegativeNEW YORK The U.S. Food and Drug Administration on Monday approved Pfizer Incs oral drug tafamidis to treat a rare and fatal heart disease called transthyretin amyloid cardiomyopathy the U.S drugmaker said http://www.reuters.com/news/health/article/us-pfizer-approval/pfizer-gets-u-s-approval-for-225000-a-year-heart-drug-idUSKCN1SC0VX2019-05-07
The active ingredients of commonlyused sunscreens end up in the bloodstream at much higher levels than current U.S. guidelines from health regulators and warrant further safety studies according to a small study conducted by U.S. Food and Drug Administration researchers and published on Monday NegativeThe active ingredients of commonlyused sunscreens end up in the bloodstream at much higher levels than current U.S. guidelines from health regulators and warrant further safety studies according to a small study conducted by U.S. Food and Drug Administration researchers and published on Monday http://www.reuters.com/news/health/article/us-health-sunscreen/high-levels-of-sunscreen-ingredients-end-up-in-the-bloodstream-study-idUSKCN1SC1VF2019-05-07
The U.S. Food and Drug Administration on Tuesday declined to approve Nabriva Therapeutics Plcs antibiotic for complicated urinary tract infections even as the nation grapples with the growing problem of antibiotic resistance PositiveThe U.S. Food and Drug Administration on Tuesday declined to approve Nabriva Therapeutics Plcs antibiotic for complicated urinary tract infections even as the nation grapples with the growing problem of antibiotic resistance http://www.reuters.com/news/health/article/us-nabriva-fda/fda-declines-to-approve-nabrivas-antibiotic-for-urinary-tract-infections-idUSKCN1S73072019-05-02
The U.S. Food and Drug Administration on Tuesday said it would allow Philip Morris to sell a heated tobacco product called IQOS in the United States a major victory for the international tobacco giant as it looks to sell more alternatives to traditional cigarettes PositiveThe U.S. Food and Drug Administration on Tuesday said it would allow Philip Morris to sell a heated tobacco product called IQOS in the United States a major victory for the international tobacco giant as it looks to sell more alternatives to traditional cigarettes http://www.reuters.com/news/health/article/us-philip-morris-fda/fda-permits-sale-of-philip-morris-iqos-tobacco-heating-alternative-to-cigarettes-idUSKCN1S629A2019-05-01
The U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Incs cholesterol drug Praluent as a treatment to cut the risk of heart attacks stroke and other major cardiovascular events NegativeThe U.S. Food and Drug Administration on Friday approved Regeneron Pharmaceuticals Incs cholesterol drug Praluent as a treatment to cut the risk of heart attacks stroke and other major cardiovascular events http://www.reuters.com/news/health/article/us-regeneron-pharms-fda-sanofi-fr/fda-approves-expanded-label-for-regeneron-sanofis-cholesterol-drug-idUSKCN1S301W2019-04-27
The U.S. Food and Drug Administration on Thursday approved Bausch Health Companies Incs topical plaque psoriasis treatment which is expected to be a key revenue driver for the company PositiveThe U.S. Food and Drug Administration on Thursday approved Bausch Health Companies Incs topical plaque psoriasis treatment which is expected to be a key revenue driver for the company http://www.reuters.com/news/health/article/us-bausch-health-fda/bausch-healths-lotion-for-plaque-psoriasis-wins-fda-approval-idUSKCN1S12DR2019-04-26
The company operates 9560 drugstores across the country and has been warned by the U.S. Food and Drug Administration for flouting tobacco sale rules by selling tobacco products to minors NegativeDrugstore retailers Walgreens Boots Alliance Inc and Rite Aid Corp said on Tuesday they would sell tobacco products to customers who are at least 21 years old amid a crackdown on teenage tobacco use http://www.reuters.com/news/health/article/us-fda-tobacco/walgreens-rite-aid-to-sell-tobacco-products-to-customers-above-21-years-idUSKCN1RZ1Q22019-04-24
The U.S. Food and Drug Administration has approved Merck Co Incs cancer therapy Keytruda as part of a combination therapy for previously untreated patients with the most common type of kidney cancer the company said on Monday PositiveThe U.S. Food and Drug Administration has approved Merck Co Incs cancer therapy Keytruda as part of a combination therapy for previously untreated patients with the most common type of kidney cancer the company said on Monday http://www.reuters.com/news/health/article/us-merck-co-fda/mercks-keytruda-wins-fda-approval-as-combination-therapy-for-kidney-cancer-idUSKCN1RY0Q32019-04-23
Generic drugmaker Teva Pharmaceutical Industries Ltd on Friday received approval from the U.S. Food and Drug Administration to market its generic nasal spray for opioid overdose the health regulator said NegativeGeneric drugmaker Teva Pharmaceutical Industries Ltd on Friday received approval from the U.S. Food and Drug Administration to market its generic nasal spray for opioid overdose the health regulator said http://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-teva-pharm-ind-generic-nasal-spray/fda-approves-tevas-generic-nasal-spray-to-treat-opioid-overdose-idUSKCN1RV15G2019-04-20
The U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop their sale and distribution in the United States the latest action by the agency to tackle safety issues related to the devices NegativeThe U.S. Food and Drug Administration on Tuesday ordered makers of transvaginal surgical mesh implants to immediately stop their sale and distribution in the United States the latest action by the agency to tackle safety issues related to the devices http://www.reuters.com/news/health/article/us-fda-surgicalmesh/fda-orders-transvaginal-surgical-mesh-pulled-from-market-idUSKCN1RS1QN2019-04-17
The U.S. Food and Drug Administration said on Friday it has sent letters to Walmart Inc Kroger Co and 10 other convenience store chains for selling tobacco products to minors NeutralThe U.S. Food and Drug Administration said on Friday it has sent letters to Walmart Inc Kroger Co and 10 other convenience store chains for selling tobacco products to minors http://www.reuters.com/news/ushttps://www.reuters.com/article/us-fda-tobacco/fda-pulls-up-walmart-kroger-others-for-selling-tobacco-to-minors-idUSKCN1RP0132019-04-13
The U.S. Food and Drug Administration said on Thursday women taking Sprout Pharmaceuticals Incs female libido pill Addyi need not completely avoid alcohol PositiveThe U.S. Food and Drug Administration said on Thursday women taking Sprout Pharmaceuticals Incs female libido pill Addyi need not completely avoid alcohol http://www.reuters.com/news/health/article/us-addyi-fda/u-s-fda-loosens-alcohol-restrictions-for-female-libido-pill-idUSKCN1RN2TI2019-04-12
The U.S. Food and Drug Administration said on Tuesday it had approved Amgen Incs osteoporosis treatment for postmenopausal women who are at high risk of fracture NeutralThe U.S. Food and Drug Administration said on Tuesday it had approved Amgen Incs osteoporosis treatment for postmenopausal women who are at high risk of fracture http://www.reuters.com/news/health/article/us-amgen-fda/amgens-postmenopausal-osteoporosis-drug-gets-fda-greenlight-idUSKCN1RL2LP2019-04-10
The U.S. Food and Drug Administration cleared the combination of dolutegravir and lamivudine to be branded as Dovato for use in newly diagnosed adults NegativeGlaxoSmithKline Plcs twodrug treatment for HIV infections won U.S. market approval on Monday boosting the British drugmakers growth prospects against competitor Gilead Sciences Inc http://www.reuters.com/news/health/article/us-gsk-hiv/gsk-wins-u-s-nod-for-two-drug-hiv-combination-idUSKCN1RK29O2019-04-09
The U.S. Food and Drug Administration on Monday refused to fully review the marketing application for Zogenix Incs treatment for seizures associated with Dravet syndrome a rare form of childhood epilepsy NegativeThe U.S. Food and Drug Administration on Monday refused to fully review the marketing application for Zogenix Incs treatment for seizures associated with Dravet syndrome a rare form of childhood epilepsy http://www.reuters.com/news/health/article/us-zogenix-fda/zogenixs-seizure-drug-filing-fails-to-pass-u-s-fda-scrutiny-idUSKCN1RK2BH2019-04-09
The CDC the U.S. Department of Agricultures Food Safety and Inspection Service the U.S. Food and Drug Administration and several states are investigating the outbreak of toxinproducing E.coli O103 infections NegativeThe Centers for Disease Control and Prevention and several other U.S. agencies are investigating an E.coli outbreak in five states the CDC said http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-ecoli/cdc-investigates-e-coli-outbreak-in-several-states-idUSKCN1RH23R2019-04-06
The U.S. Food and Drug Administration on Wednesday warned of potential safety risks from the use of ecigarettes after it found certain users had suffered from seizures NegativeThe U.S. Food and Drug Administration on Wednesday warned of potential safety risks from the use of ecigarettes after it found certain users had suffered from seizures http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-vaping/u-s-fda-warns-of-potential-seizure-risk-in-some-users-of-e-cigarettes-idUSKCN1RF1OW2019-04-04
ZURICH Novartis AG has won U.S. Food and Drug Administration approval for multiple sclerosis drug Mayzent as the Swiss company targets patients whose disease advances from intermittent attacks to a gradually worsening condition PositiveZURICH Novartis AG has won U.S. Food and Drug Administration approval for multiple sclerosis drug Mayzent as the Swiss company targets patients whose disease advances from intermittent attacks to a gradually worsening condition http://www.reuters.com/news/health/article/us-fda-mayzent/novartis-ms-drug-wins-fdas-blessing-amid-scrutiny-of-88000-annual-price-idUSKCN1R80192019-03-28
Novartis AG won U.S. Food and Drug Administration approval on Tuesday for its new multiple sclerosis drug Mayzent as the Swiss drugmaker seeks to tap a new group of patients in whom the neurological disease has shifted from intermittent attacks to a gradually worsening progression NegativeMarch 26 story was refiled to fix typing mistake in last http://www.reuters.com/news/health/article/us-fda-mayzent/novartis-gets-u-s-approval-for-new-drug-to-treat-multiple-sclerosis-idUSKCN1R80192019-03-27
Purdue has argued that U.S. Food and Drug Administrationapproved labels for its opioids carried warnings about the risk of abuse and misuse associated with them NegativeOxyContin maker Purdue Pharma LP and members of the wealthy Sackler family that own the company reached a million settlement to resolve a lawsuit brought by the state of Oklahoma accusing the drugmaker of fueling an opioid abuse epidemic http://www.reuters.com/news/health/article/us-usa-opioids-litigation/purdue-pharma-agrees-to-270-million-settlement-in-oklahoma-opioid-case-idUSKCN1R70CH2019-03-27
The U.S. Food and Drug Administration on Thursday said cybersecurity vulnerabilities were identified in Medtronic Plcs implantable cardiac devices clinic programmers and home monitors NegativeThe U.S. Food and Drug Administration on Thursday said cybersecurity vulnerabilities were identified in Medtronic Plcs implantable cardiac devices clinic programmers and home monitors http://www.reuters.com/legal/article/us-medtronic-cyber/fda-says-cybersecurity-vulnerabilities-found-in-some-medtronic-devices-idUSKCN1R300H2019-03-23
The U.S. Food and Drug Administration declined to approve a drug developed by Sanofi SA and Lexicon Pharmaceuticals Inc intended for use with insulin in patients with type 1 diabetes the companies said on Friday NegativeThe U.S. Food and Drug Administration declined to approve a drug developed by Sanofi SA and Lexicon Pharmaceuticals Inc intended for use with insulin in patients with type 1 diabetes the companies said on Friday http://www.reuters.com/news/health/article/us-sanofi-fr-fda/fda-rejects-sanofi-lexicon-add-on-pill-for-type-1-diabetes-idUSKCN1R32DM2019-03-23
Under U.S. Food and Drug Administration policy floodsoaked grain is considered adulterated and must be destroyed according to Iowa State University NegativeWINSLOW Neb http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-weather-agriculture/u-s-farmers-face-devastation-following-midwest-floods-idUSKCN1R12J02019-03-22
The U.S. Food and Drug Administration on Wednesday said it will temporarily allow certain manufacturers to sell blood pressure medications containing specified levels of a probable cancercausing impurity in order to maintain adequate supplies of the drug NegativeThe U.S. Food and Drug Administration on Wednesday said it will temporarily allow certain manufacturers to sell blood pressure medications containing specified levels of a probable cancercausing impurity in order to maintain adequate supplies of the drug http://www.reuters.com/news/health/article/us-health-bloodpressure-fda/fda-allows-sale-of-certain-blood-pressure-drugs-amid-shortage-idUSKCN1R12IA2019-03-21
In 2007 the U.S. Food and Drug Administration required stimulant manufacturers to warn that their products might unexpectedly cause psychotic or manic symptoms NegativeAmong 110923 patients getting amphetamine Adzenys XRODT 237 subsequently received a psychosis diagnosis or 0 http://www.reuters.com/news/health/article/us-health-adhd-adderall-psychosis/with-adhd-amphetamine-has-double-the-psychosis-risk-of-methylphenidate-idUSKCN1R12PR2019-03-21
San Francisco officials on Tuesday proposed legislation that would ban the sale of ecigarettes from companies such as Juul until a review by the U.S. Food and Drug Administration as part of the citys efforts to tackle underage vaping NegativeSan Francisco officials on Tuesday proposed legislation that would ban the sale of ecigarettes from companies such as Juul until a review by the U.S. Food and Drug Administration as part of the citys efforts to tackle underage vaping http://www.reuters.com/legal/article/us-usa-vaping-sanfrancisco/san-francisco-officials-look-to-ban-sale-of-e-cigarettes-idUSKCN1R02L22019-03-20
The U.S. Food and Drug Administration has issued warning letters to Sientra Inc and a Johnson Johnson unit for failing to comply with the postapproval study requirements for their breast implants NegativeThe U.S. Food and Drug Administration has issued warning letters to Sientra Inc and a Johnson Johnson unit for failing to comply with the postapproval study requirements for their breast implants http://www.reuters.com/news/health/article/us-sientra-fda/jj-and-sientra-get-fda-warning-letters-over-breast-implants-idUSKCN1R02H22019-03-20
The U.S. Food and Drug Administration on Tuesday approved Sage Therapeutics Incs drug for postpartum depression marking the first approval of a treatment specifically developed for the condition that affects a new mothers ability to care for herself or her baby PositiveThe U.S. Food and Drug Administration on Tuesday approved Sage Therapeutics Incs drug for postpartum depression marking the first approval of a treatment specifically developed for the condition that affects a new mothers ability to care for herself or her baby http://www.reuters.com/news/health/article/us-sage-fda/sage-gets-u-s-approval-for-first-postpartum-depression-therapy-idUSKCN1R02PM2019-03-20
The U.S. Food and Drug Administration on Wednesday released formal plans to curb the sale of flavored ecigarettes and slow a surge in teenage use of the popular nicotine devices NegativeThe U.S. Food and Drug Administration on Wednesday released formal plans to curb the sale of flavored ecigarettes and slow a surge in teenage use of the popular nicotine devices http://www.reuters.com/news/health/article/us-usa-vaping-flavors/u-s-proposes-stricter-curbs-on-e-cigarette-sales-idUSKBN1QU2052019-03-14
U.S. President Donald Trumps administration has tapped National Cancer Institute Director Norman Sharpless to serve as acting commissioner for the Food and Drug Administration following the resignation of Scott Gottlieb earlier this month NegativeU.S. President Donald Trumps administration has tapped National Cancer Institute Director Norman Sharpless to serve as acting commissioner for the Food and Drug Administration following the resignation of Scott Gottlieb earlier this month http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-fda/national-cancer-institute-chief-to-serve-as-acting-fda-head-idUSKBN1QT2C82019-03-13
The U.S. Food and Drug Administration said on Tuesday it had approved a new generic version of blood pressure medicine valsartan as the agency looks to ease shortages triggered by several manufacturers recalling the drug over possible cancer risk NegativeThe U.S. Food and Drug Administration said on Tuesday it had approved a new generic version of blood pressure medicine valsartan as the agency looks to ease shortages triggered by several manufacturers recalling the drug over possible cancer risk http://www.reuters.com/news/health/article/us-fda-valsartan/fda-approves-generic-valsartan-amid-drug-shortage-idUSKBN1QT2RR2019-03-13
The U.S. Food and Drug Administration said it approved expanded use of Regeneron Pharmaceuticals Inc and Sanofi SAs eczema drug Dupixent to include patients aged between 12 and 17 a boost for both the companies in the worlds largest market for drugs PositiveThe U.S. Food and Drug Administration said it approved expanded use of Regeneron Pharmaceuticals Inc and Sanofi SAs eczema drug Dupixent to include patients aged between 12 and 17 a boost for both the companies in the worlds largest market for drugs http://www.reuters.com/news/health/article/us-regeneron-pharms-fda-atopic-dermatiti/regeneron-sanofi-wins-u-s-approval-for-expanded-use-of-skin-drug-idUSKBN1QS2GS2019-03-12
The U.S. Food and Drug Administration on Tuesday said it approved a Johnson Johnson nasal spray antidepressant for people resistant to other treatments but placed restrictions on use of the drug which it warned could be misused and abused NegativeThe U.S. Food and Drug Administration on Tuesday said it approved a Johnson Johnson nasal spray antidepressant for people resistant to other treatments but placed restrictions on use of the drug which it warned could be misused and abused http://www.reuters.com/news/ushttps://www.reuters.com/article/us-johnson-johnson-fda/jj-nasal-spray-gets-u-s-approval-as-first-new-type-of-anti-depressant-in-decades-idUSKCN1QN04J2019-03-07
WASHINGTON U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Tuesday that he plans to step down next month a sudden resignation that calls into question how the agency will handle issues such as surging ecigarette use among teens and efforts to increase competition in prescription drugs NegativeWASHINGTON U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Tuesday that he plans to step down next month a sudden resignation that calls into question how the agency will handle issues such as surging ecigarette use among teens and efforts to increase competition in prescription drugs http://www.reuters.com/legal/article/us-usa-fda-gottlieb/u-s-fda-chief-tough-on-e-cigarettes-steps-down-abruptly-idUSKCN1QM2GZ2019-03-07
A coalition of these groups wrote Trump last month asking him to immediately halt the Food and Drug Administrations aggressive regulatory on ecigarette businesses NegativeWASHINGTON U.S. Food and Drug Administration Commissioner Scott Gottlieb said on Tuesday that he plans to step down next month a sudden resignation that calls into question how the agency will handle issues such as surging ecigarette use among teens and efforts to increase competition in prescription drugs http://www.reuters.com/legal/article/us-usa-fda-gottlieb/u-s-fda-chief-tough-on-e-cigarettes-steps-down-abruptly-idUSKCN1QM2GZ2019-03-07
The U.S. Food and Drug Administration called on Congress to modernize rules for cosmetics safety on Tuesday after it issued an alert warning consumers not to use three cosmetics products sold by Claires Stores Inc because they tested positive for asbestos a known carcinogen NegativeThe U.S. Food and Drug Administration called on Congress to modernize rules for cosmetics safety on Tuesday after it issued an alert warning consumers not to use three cosmetics products sold by Claires Stores Inc because they tested positive for asbestos a known carcinogen http://www.reuters.com/news/health/article/us-fda-claires-asbestos/fda-finds-asbestos-in-three-claires-cosmetics-products-idUSKCN1QM2DD2019-03-07
WASHINGTON U.S. Food and Drug Administration chief Scott Gottlieb said on Tuesday he plans to step down in a month calling into question how the agency will handle critical issues such as ecigarette use among teens and efforts to increase competition in prescription drugs NegativeWASHINGTON U.S. Food and Drug Administration chief Scott Gottlieb said on Tuesday he plans to step down in a month calling into question how the agency will handle critical issues such as ecigarette use among teens and efforts to increase competition in prescription drugs http://www.reuters.com/news/health/article/us-usa-fda-gottlieb/fda-chief-gottlieb-resigns-idUSKCN1QM2GZ2019-03-06
The U.S. Food and Drug Administration called on Congress on Tuesday to modernize rules for cosmetics safety after it issued an alert about asbestos contamination detected in three products sold by retailer Claires NegativeThe U.S. Food and Drug Administration called on Congress on Tuesday to modernize rules for cosmetics safety after it issued an alert about asbestos contamination detected in three products sold by retailer Claires http://www.reuters.com/news/health/article/us-fda-claires-asbestos/fda-finds-asbestos-in-three-products-sold-by-claires-idUSKCN1QM2DD2019-03-06
Purdue denies the allegations arguing that the U.S. Food and Drug Administrationapproved labels for its opioids carried warnings about the risk of abuse and misuse associated with the pain treatments NegativeOxyContin maker Purdue Pharma LP is exploring filing for bankruptcy to address potentially significant liabilities from roughly 2000 lawsuits alleging the drugmaker contributed to the deadly opioid crisis sweeping the United States people familiar with the matter said on Monday http://www.reuters.com/finance/article/us-purduepharma-bankruptcy-exclusive/exclusive-oxycontin-maker-purdue-pharma-exploring-bankruptcy-sources-idUSKCN1QL1KL2019-03-05
Despite concerns around its use the European Medicines Agency has approved Dengvaxia and the U.S. Food and Drug Administration has granted priority review with a decision expected in May NegativeThe Philippine Department of Justice on Friday said it had found probable cause to indict officials from French drugmaker Sanofi and former and current Philippine health officials over 10 deaths it said were linked to use of a dengue vaccine http://www.reuters.com/news/health/article/us-sanofi-fr-philippines/philippines-to-charge-officials-of-sanofi-government-over-dengue-vaccine-idUSKCN1QI41L2019-03-02
The U.S. Food and Drug Administration is also looking into whether these types of impurities could be found in other classes of drugs a spokeswoman for the regulator said NegativeU.S. health regulators said on Friday a third cancercausing toxin was found in some blood pressure pills recalled by Indias Hetero Labs Ltd a day earlier adding to a global recall of commonly used drugs to treat hypertension http://www.reuters.com/news/health/article/us-health-bloodpressure-fda/new-cancer-causing-toxin-found-in-recalled-blood-pressure-pills-idUSKCN1QI4XF2019-03-02
The U.S. Food and Drug Administration has prohibited companies from adding CBD to food but many drinks companies have announced plans to use it PositiveLifestyle guru Martha Stewart is joining Canadian marijuana producer Canopy Growth as an adviser to help develop and launch a line of potbased products for humans and animals it said on Thursday http://www.reuters.com/news/mediahttps://www.reuters.com/article/us-canopy-growth-marthastewart/martha-stewart-canadian-pot-business-in-joint-effort-aimed-at-pets-idUSKCN1QH1UN2019-03-01
The U.S. Food and Drug Administration said on Thursday two of the 16 currently used main chemical ingredients in overthecounter sunscreen products are considered safe as part of a proposal NeutralThe U.S. Food and Drug Administration said on Thursday two of the 16 currently used main chemical ingredients in overthecounter sunscreen products are considered safe as part of a proposal http://www.reuters.com/legal/article/us-fda-sunscreen/u-s-fda-proposes-new-regulations-for-over-the-counter-sunscreens-idUSKCN1QA2RI2019-02-22
Food and Drug Administration Director General Nela Charade Puno said on Tuesday registration certificates for Dengvaxia products have been revoked because of Sanofis brazen of the agencys directives NegativeMANILA The Philippines has permanently halted the sale distribution and marketing of Sanofis dengue vaccine in the country after the French drug maker failed to meet the directives of regulators http://www.reuters.com/news/health/article/us-sanofi-fr-philippines/philippines-revokes-sanofis-product-license-for-dengue-vaccine-idUSKCN1Q81672019-02-20
An advisory panel to the U.S. Food and Drug Administration on Tuesday voted in favor of Johnson Johnsons experimental nasal spray which has a compound similar to oftenabused ketamine bringing the drug closer to approval PositiveAn advisory panel to the U.S. Food and Drug Administration on Tuesday voted in favor of Johnson Johnsons experimental nasal spray which has a compound similar to oftenabused ketamine bringing the drug closer to approval http://www.reuters.com/news/health/article/us-johnson-johnson-fda/johnson-johnsons-nasal-spray-for-depression-wins-fda-panel-backing-idUSKCN1Q12G52019-02-13
The U.S. Food and Drug Administration has warned more than a dozen companies against selling unapproved products which claim to treat Alzheimers disease and other serious ailments the agency said on Monday NegativeThe U.S. Food and Drug Administration has warned more than a dozen companies against selling unapproved products which claim to treat Alzheimers disease and other serious ailments the agency said on Monday http://www.reuters.com/news/health/article/us-fda-alzheimers/fda-rebukes-17-firms-for-selling-fake-alzheimers-drugs-idUSKCN1Q01QE2019-02-12
The U.S. Food and Drug Administration has warned more than a dozen companies against selling unapproved products which claim to treat Alzheimers disease and other serious ailments the agency said on Monday NegativeThe U.S. Food and Drug Administration has warned more than a dozen companies against selling unapproved products which claim to treat Alzheimers disease and other serious ailments the agency said on Monday http://www.reuters.com/news/health/article/us-fda-alzheimers/fda-rebukes-17-firms-for-selling-fake-alzheimers-drugs-idUSKCN1Q01QE2019-02-12
The U.S. Food and Drug Administration has warned more than a dozen companies against selling unapproved products which claim to treat Alzheimers disease and other serious ailments the agency said on Monday NegativeThe U.S. Food and Drug Administration has warned more than a dozen companies against selling unapproved products which claim to treat Alzheimers disease and other serious ailments the agency said on Monday http://www.reuters.com/news/health/article/us-fda-alzheimers/fda-rebukes-17-firms-for-selling-fake-alzheimers-drugs-idUSKCN1Q01QE2019-02-12
The U.S. Food and Drug Administration said on Thursday it was taking action against certain retailers including Walgreen Boots Alliance for repeatedly flouting tobacco sale rules including sale of cigars and menthol cigarettes to minors NeutralThe U.S. Food and Drug Administration said on Thursday it was taking action against certain retailers including Walgreen Boots Alliance for repeatedly flouting tobacco sale rules including sale of cigars and menthol cigarettes to minors http://www.reuters.com/news/ushttps://www.reuters.com/article/us-fda-tobacco/fda-pulls-up-walgreens-for-violating-tobacco-sale-laws-by-selling-to-minors-idUSKCN1PW1ZT2019-02-08
The U.S. Food and Drug Administration on Friday declined to approve Alkermes Plcs opioidbased depression treatment citing the need for additional data to prove the effectiveness of the drug NegativeThe U.S. Food and Drug Administration on Friday declined to approve Alkermes Plcs opioidbased depression treatment citing the need for additional data to prove the effectiveness of the drug http://www.reuters.com/news/health/article/us-alkermes-fda/fda-declines-to-approve-alkermes-opioid-based-depression-drug-idUSKCN1PQ5T92019-02-02
Ajovy was approved by the U.S. Food and Drug Administration in September last year and the company had said it was seeing a very strong of the treatment PositiveTeva Pharmaceutical Industries said a European Medicines Agency panel on Friday recommended approving migraine treatment Ajovy a drug that the company has been counting on to revive its fortune http://www.reuters.com/news/health/article/us-teva-pharm-ind-ajovy-ema/tevas-migraine-drug-gets-eu-panel-nod-idUSKCN1PQ4PH2019-02-02
NEW YORK Additional shortages of blood pressure drugs in the United States are possible following recent recalls related to traces of a probable carcinogen found in some versions a particular class of hypertension medicines the U.S. Food and Drug Administration said on Friday NegativeNEW YORK Additional shortages of blood pressure drugs in the United States are possible following recent recalls related to traces of a probable carcinogen found in some versions a particular class of hypertension medicines the U.S. Food and Drug Administration said on Friday http://www.reuters.com/news/health/article/us-health-bloodpressure-fda/more-blood-pressure-drugs-may-have-shortages-after-recalls-fda-idUSKCN1PJ1N22019-01-26
The U.S. Food and Drug Administration said on Friday it had approved a biosimilar to Roche Holding AGs blockbuster breast cancer treatment Herceptin PositiveThe U.S. Food and Drug Administration said on Friday it had approved a biosimilar to Roche Holding AGs blockbuster breast cancer treatment Herceptin http://www.reuters.com/news/health/article/us-merck-co-fda-samsung-bioepis/samsung-bioepis-biosimilar-to-roches-herceptin-wins-fda-nod-idUSKCN1PC2I92019-01-19
The drug is currently approved by the U.S. Food and Drug Administration in six disease areas with nine treatment indications AbbVie said PositiveAbbVie Inc said on Friday its blockbuster cancer treatment in combination with chemotherapy agents failed to meet the main goal in a latestage study of patients with a form of pancreatic cancer http://www.reuters.com/news/health/article/us-abbvie-study/abbvies-imbruvica-fails-to-meet-main-goal-in-pancreatic-cancer-study-idUSKCN1PC2KS2019-01-19
Immunomedics Inc said on Thursday the U.S. Food and Drug Administration declined to grant accelerated approval for its breast cancer treatment sacituzumab PositiveImmunomedics Inc said on Thursday the U.S. Food and Drug Administration declined to grant accelerated approval for its breast cancer treatment sacituzumab http://www.reuters.com/news/health/article/us-immunomedics-fda/immunomedics-cancer-treatment-fails-to-win-accelerated-approval-from-the-fda-idUSKCN1PC03G2019-01-18
About 400 U.S. Food and Drug Administration staffers have returned to their posts from furlough including some food inspectors and support professionals Commissioner Scott Gottlieb said in a tweet on Tuesday NegativeAbout 400 U.S. Food and Drug Administration staffers have returned to their posts from furlough including some food inspectors and support professionals Commissioner Scott Gottlieb said in a tweet on Tuesday http://www.reuters.com/politicshttps://www.reuters.com/article/us-usa-shutdown-fda/hundreds-of-fda-staff-return-to-work-amid-shutdown-commissioner-idUSKCN1P92IA2019-01-16
The U.S. Food and Drug Administration in August declined to approve the drug requesting more information and citing safety issues outside the United States NegativeCanadas health regulator on Friday said it was restricting the use of Allergan Plcs uterine fibroid treatment Esmya after discovering a risk of serious liver injury from the drug http://www.reuters.com/news/health/article/us-allergan-esmya/health-canada-places-restrictions-on-allergans-fibroid-treatment-esmya-idUSKCN1P51UO2019-01-12
A U.S. unit of Indian generic drugmaker Aurobindo Pharma Ltd will recall 80 lots of medicines containing blood pressure drug valsartan that were found to have a probable cancercausing impurity according to the U.S. Food and Drug Administration NegativeA U.S. unit of Indian generic drugmaker Aurobindo Pharma Ltd will recall 80 lots of medicines containing blood pressure drug valsartan that were found to have a probable cancercausing impurity according to the U.S. Food and Drug Administration http://www.reuters.com/news/health/article/us-aurobindo-pharm-valsartan-united-stat/aurobindo-pharma-to-recall-80-lots-of-blood-pressure-medicine-valsartan-in-the-us-idUSKCN1OW19O2019-01-02





SentenceSentimentTitleUrlDate
The U.S. Food and Drug Administration plans to meet toplevel executives of ecigarette makers the agencys chief said on Thursday hinting that some companies seem to be backing away from commitments related to youths access to ecigarettes NegativeThe U.S. Food and Drug Administration plans to meet toplevel executives of ecigarette makers the agencys chief said on Thursday hinting that some companies seem to be backing away from commitments related to youths access to ecigarettes http://www.reuters.com/news/health/article/us-usa-health-ecigarettes/fda-chief-to-meet-e-cigarette-makers-amid-crackdown-idUSKCN1OQ1D12018-12-28
The company has notified the U.S. Food and Drug Administration and is working with the agency on a mitigation plan it said NeutralCapricor Therapeutics Inc said on Wednesday it had put on hold a clinical trial of its drug to treat Duchenne muscular dystrophy a musclewasting disorder citing a safety review http://www.reuters.com/news/health/article/us-capricor-study/u-s-drug-developer-capricor-places-duchenne-drug-trial-on-hold-idUSKCN1OP0O82018-12-26
The U.S. Food and Drug Administration approved on Friday Alexion Pharmaceuticals Incs rare blood disorder drug Ultomiris an early backing that also solidifies the companys dominant market position NegativeThe U.S. Food and Drug Administration approved on Friday Alexion Pharmaceuticals Incs rare blood disorder drug Ultomiris an early backing that also solidifies the companys dominant market position http://www.reuters.com/news/health/article/us-alexion-pharms-fda/alexion-wins-early-u-s-approval-for-rare-blood-disorder-drug-idUSKCN1OK1RW2018-12-22
The U.S. Food and Drug Administration on Thursday approved a new protocol for a postmarketing study of Bayer AGs Essure birthcontrol device as the regulator seeks more information on the devices safety NegativeThe U.S. Food and Drug Administration on Thursday approved a new protocol for a postmarketing study of Bayer AGs Essure birthcontrol device as the regulator seeks more information on the devices safety http://www.reuters.com/news/health/article/us-bayer-essure/u-s-fda-approves-new-protocol-for-study-on-bayers-birth-control-device-idUSKCN1OJ2KF2018-12-21
The agencys recommendation comes a day after an advisory panel to the U.S. Food and Drug Administration narrowly recommended prescribing the drug along with addictive painkillers NegativeThe U.S. Department of Health and Human Services on Wednesday recommended prescribing or coprescribing the opioid overdose reversal drug naloxone to highrisk patients http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-opioids-naloxone/u-s-agency-recommends-opioid-overdose-antidote-to-high-risk-patients-idUSKCN1OI2IJ2018-12-20
Novartiss announcement comes after the U.S. Food and Drug Administration announcement this month of changes meant to bring down insulin prices that have been escalating crimping access and harming health NegativeZURICH Swiss drugmaker Novartis aims to become a big player in supplying insulin to swelling numbers of diabetics signing a deal with Chinas Gan Lee on versions of three blockbuster brands as the U.S. government is seeking to slash insulin costs http://www.reuters.com/places/chinahttps://www.reuters.com/article/us-novartis-insulin/novartis-chinas-gan-lee-push-into-insulin-amid-diabetes-epidemic-idUSKBN1OI1DE2018-12-20
Last month the U.S. Food and Drug Administration facing mounting pressure to act on the rising popularity of vaping devices announced sweeping new restrictions on flavored tobacco products including ecigarettes NegativeThe percentage of high school seniors who used ecigarettes in the last 30 days nearly doubled to 20 http://www.reuters.com/news/health/article/us-usa-vaping-survey/e-cigarette-usage-nearly-doubles-in-u-s-high-schools-survey-idUSKBN1OG0CJ2018-12-18
TEL AVIV Therapeutics Inc has received approval from the U.S. Food and Drug Administration to begin a clinical trial of its experimental stem cell treatment in patients with progressive multiple sclerosis PositiveTEL AVIV Therapeutics Inc has received approval from the U.S. Food and Drug Administration to begin a clinical trial of its experimental stem cell treatment in patients with progressive multiple sclerosis http://www.reuters.com/news/health/article/us-brainstorm-cell-study/brainstorm-gets-fda-okay-for-stem-cell-trial-in-ms-patients-idUSKBN1OG1EX2018-12-18
The PTAB decision alone does not affect the existing 30month stay and Mylan does not have tentative Food and Drug Administration approval for its products at this time NegativeU.S. generics drugmaker Mylan said on Thursday that the United States Patent and Trademark Office had rejected Sanofis infringement claims relating to insulin drug Lantus http://www.reuters.com/news/health/article/us-mylan-sanofi-lantus/mylan-says-sanofi-loses-lantus-insulin-patent-claims-idUSKBN1OC1MN2018-12-14
The U.S. Food and Drug Administration on Monday cleared Pear Therapeutics mobile application to help increase retention of patients undergoing outpatient treatment for opioid abuse NegativeThe U.S. Food and Drug Administration on Monday cleared Pear Therapeutics mobile application to help increase retention of patients undergoing outpatient treatment for opioid abuse http://www.reuters.com/legal/article/usa-opioids/fda-clears-pear-therapeutics-mobile-app-to-help-treat-opioid-abuse-idUSKBN1O92KG2018-12-12
Winning the speedy review from the U.S. Food and Drug Administration sets up possible U.S. approval for Tecentriq in this indication by March 18 the drugmaker said in a statement PositiveZURICH Swiss group Roche Holding AG said on Wednesday its Tecentriq immunotherapy mixed with chemotherapy won priority review from the U.S. regulator for treating a type of lung cancer a potential boost to the drug that has been trailing rivals revenues http://www.reuters.com/news/health/article/us-roche-tecentriq/roches-tecentriq-wins-speedy-u-s-fda-review-for-small-cell-lung-cancer-idUSKBN1O40GZ2018-12-06
Amgen said AMG420 which targets a protein linked to multiple myeloma known as BCMA has been given fast track status by the U.S. Food and Drug Administration PositiveSAN DIEGO Amgen Inc updating the first trial of its bispecific antibody for multiple myeloma said on Monday seven out of 10 patients given the secondhighest dose of AMG420 responded to the drug including four with no detectable cancer http://www.reuters.com/news/health/article/us-amgen-myeloma/amgen-antibody-shows-promise-in-myeloma-trial-gets-fda-fast-track-idUSKBN1O305Z2018-12-05
ZURICH Novartiss gene therapy for spinal muscular atrophy could be approved in May 2019 after the U.S. Food and Drug Administration agreed to an accelerated review of the Swiss drugmakers treatment PositiveZURICH Novartiss gene therapy for spinal muscular atrophy could be approved in May 2019 after the U.S. Food and Drug Administration agreed to an accelerated review of the Swiss drugmakers treatment http://www.reuters.com/news/health/article/us-novartis-sma/novartis-sma-treatment-could-get-fda-approval-in-may-idUSKBN1O20EU2018-12-04
Eight medical device makers including a startup that uses virtual reality to treat chronic pain topped an innovation contest aimed at addressing the opioid crisis the U.S. Food and Drug Administration said on Friday NegativeEight medical device makers including a startup that uses virtual reality to treat chronic pain topped an innovation contest aimed at addressing the opioid crisis the U.S. Food and Drug Administration said on Friday http://www.reuters.com/news/health/article/us-usa-opioids/fda-picks-eight-medical-device-firms-to-help-battle-opioid-crisis-idUSKCN1NZ2D22018-12-01
The U.S. Food and Drug Administration approved on Friday the first test a diagnostic from Meridian Bioscience Inc to help detect a type of herpes virus in newborns PositiveThe U.S. Food and Drug Administration approved on Friday the first test a diagnostic from Meridian Bioscience Inc to help detect a type of herpes virus in newborns http://www.reuters.com/news/health/article/us-meridian-biosci-fda/fda-approves-meridian-biosciences-test-for-herpes-in-newborns-idUSKCN1NZ2P82018-12-01
The Food and Drug Administrations warning letter to privately held Electric Lotus LLC is part of its drive to limit the use of tobacco products among youth NegativeThe U.S. health regulator on Thursday warned a Californiabased manufacturer and retailer against advertising its ecigarette liquids with nicotine in a way that may cause the products to resemble kidfriendly food like juice boxes and cookies http://www.reuters.com/news/health/article/us-fda-tobacco/fda-warns-e-cigarette-liquid-maker-against-products-resembling-food-for-kids-idUSKCN1NY2052018-11-30
The approval by the U.S. Food and Drug Administration is part of the agencys plan to encourage development of cheaper biosimilars amid rising prices of prescription medicines NegativeCelltrion Incs Truxima on Wednesday became the first biosimilar to Roche Holding AGs cancer drug Rituxan to be approved in the United States to treat nonHodgkins lymphoma http://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-celltrion-fda/fda-approves-first-biosimilar-to-roches-cancer-drug-rituxan-idUSKCN1NX2IQ2018-11-29
The U.S. Food and Drug Administration on Wednesday approved a blood cancer treatment from Japans Astellas Pharma Inc making it the first targeted therapy to treat patients with a certain mutation PositiveThe U.S. Food and Drug Administration on Wednesday approved a blood cancer treatment from Japans Astellas Pharma Inc making it the first targeted therapy to treat patients with a certain mutation http://www.reuters.com/places/japan/article/us-astellas-pharma-fda/astellas-pharma-gets-u-s-nod-for-blood-cancer-treatment-idUSKCN1NX2JX2018-11-29
A Loxo Oncology Inc drug shown to be effective against a wide variety of cancers driven by a single rare genetic mutation has won U.S. approval the Food and Drug Administration announced on Monday PositiveA Loxo Oncology Inc drug shown to be effective against a wide variety of cancers driven by a single rare genetic mutation has won U.S. approval the Food and Drug Administration announced on Monday http://www.reuters.com/news/health/article/us-cancer-loxo-fda/loxo-bayer-drug-for-cancers-driven-by-rare-mutation-gets-u-s-nod-idUSKCN1NV2OI2018-11-27
Zafgen Inc said on Monday the U.S. Food and Drug Administration had placed a clinical hold on U.S. trials of its experimental diabetes drug citing possible heart safety risks PositiveZafgen Inc said on Monday the U.S. Food and Drug Administration had placed a clinical hold on U.S. trials of its experimental diabetes drug citing possible heart safety risks http://www.reuters.com/news/health/article/us-zafgen-fda/fda-puts-zafgens-diabetes-trial-on-hold-idUSKCN1NV1GF2018-11-27
On Wednesday Scott Gottlieb head of the U.S. Food and Drug Administration told NBC News that the lettuce that caused the E.coli infection may have come from California NegativeNEW YORK Romaine lettuce still had a place at the salad bars of some cafes and delicatessens in New York City on Wednesday despite a blanket warning to Americans from U.S. public health officials that none of the lettuce was safe to eat because it might be contaminated by E.coli http://www.reuters.com/news/ushttps://www.reuters.com/article/us-health-romaine/romaine-is-on-the-menu-at-some-new-york-delis-despite-e-coli-warning-idUSKCN1NQ2LT2018-11-22
The U.S. Food and Drug Administration on Wednesday approved Pfizer Incs drug to treat a form of blood cancer in newly diagnosed patients as a combination therapy PositiveThe U.S. Food and Drug Administration on Wednesday approved Pfizer Incs drug to treat a form of blood cancer in newly diagnosed patients as a combination therapy http://www.reuters.com/news/health/article/us-pfizer-fda/fda-approves-new-blood-cancer-treatment-from-pfizer-idUSKCN1NQ2B92018-11-22
Mylan NV said on Tuesday it is addressing issues raised in a warning letter it received earlier this month from the U.S. Food and Drug Administration which flagged concerns regarding the drugmakers manufacturing plant in West Virginia NegativeMylan NV said on Tuesday it is addressing issues raised in a warning letter it received earlier this month from the U.S. Food and Drug Administration which flagged concerns regarding the drugmakers manufacturing plant in West Virginia http://www.reuters.com/news/health/article/us-mylan-fda/mylan-gets-fda-warning-letter-over-infractions-at-west-virginia-plant-idUSKCN1NP2OM2018-11-21
BOSTON A top U.S. Food and Drug Administration official testified on Monday that the agency has concerns about drugs made by compounding pharmacies and still sees problems with them six years after a fungal meningitis outbreak tied to a Massachusetts pharmacy killed 76 people NegativeBOSTON A top U.S. Food and Drug Administration official testified on Monday that the agency has concerns about drugs made by compounding pharmacies and still sees problems with them six years after a fungal meningitis outbreak tied to a Massachusetts pharmacy killed 76 people http://www.reuters.com/news/health/article/us-massachusetts-meningitis/trial-spotlights-u-s-drug-safety-concerns-at-compounding-pharmacies-idUSKCN1NO2F82018-11-20
Novartis AG said on Friday the U.S. Food and Drug Administration expanded the use of its low platelets drug to treat patients with a rare genetic blood disorder NegativeNovartis AG said on Friday the U.S. Food and Drug Administration expanded the use of its low platelets drug to treat patients with a rare genetic blood disorder http://www.reuters.com/news/health/article/us-novartis-fda/novartis-blood-disorder-drug-gets-fda-approval-for-expanded-use-idUSKCN1NL2OY2018-11-18
Aquestive Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its erectile dysfunction treatment and sought additional data NegativeAquestive Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its erectile dysfunction treatment and sought additional data http://www.reuters.com/news/health/article/us-aquestive-therap-fda/fda-declines-to-approve-aquestives-viagra-rival-idUSKCN1NL2PI2018-11-18
The U.S. Food and Drug Administration on Thursday announced sweeping new restrictions on flavored tobacco products including electronic cigarettes popular among teenagers in an effort to prevent a new generation of nicotine addicts NegativeThe U.S. Food and Drug Administration on Thursday announced sweeping new restrictions on flavored tobacco products including electronic cigarettes popular among teenagers in an effort to prevent a new generation of nicotine addicts http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-vaping-flavors/fda-to-ban-flavored-e-cigarettes-at-u-s-convenience-stores-idUSKCN1NK26T2018-11-16
And this month Novartis abandoned plans to get U.S. approval for its version of Roches Rituxan after the U.S. Food and Drug Administration demanded more information NegativeZURICH Novartis launched a copy of Johnson Johnsons inflammationfighting Remicade in Germany on Thursday as the Swiss drugmaker aims to catch rival biosimilars that are already available in Europes largest healthcare market http://www.reuters.com/news/health/article/us-novartis-biosimilar/novartis-launches-third-to-market-remicade-copy-in-germany-idUSKCN1NK2CS2018-11-16
Novartis concluded others would be first to market in the United States before it could generate data required by the U.S. Food and Drug Administration NeutralZURICH Swiss drugmaker Novartis is completely to its billionperyear Sandoz generics business a spokesman said on Thursday after a newspaper reported Chief Executive Vas Narasimhan planned to split the unit off http://www.reuters.com/news/health/article/us-novartis-sandoz/novartis-completely-committed-to-sandoz-has-no-split-off-plan-idUSKCN1NK11S2018-11-16
Tobacco shares were rocked by a Wall Street Journal report that the U.S. Food and Drug Administration plans to pursue a ban on menthol cigarettes NegativeLONDON European shares were lower on Monday led by a selloff in technology stocks after earnings and news from German heavyweights Infineon and SAP and tobacco was hit by new signs of U.S. regulators tightening the screws on menthol cigarettes http://www.reuters.com/finance/markets/article/us-europe-stocks/tech-tobacco-push-european-stocks-into-red-ending-fragile-rebound-idUSKCN1NH0UF2018-11-13
LOS ANGELES The U.S. Food and Drug Administration next week will issue a ban on the sale of fruit and candy flavored electronic cigarettes in convenience stores and gas stations an agency official said in a move to counter a surge in teenage use of ecigarettes NegativeLOS ANGELES The U.S. Food and Drug Administration next week will issue a ban on the sale of fruit and candy flavored electronic cigarettes in convenience stores and gas stations an agency official said in a move to counter a surge in teenage use of ecigarettes http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-health-vaping/u-s-to-restrict-e-cigarette-flavors-to-fight-teenage-vaping-epidemic-idUSKCN1NE0C62018-11-10
PARIS The U.S. Food Drug Administration regulator has given more positive feedback on the Dupixent eczema treatment being developed by drugmakers Sanofi and Regeneron the companies said on Tuesday PositivePARIS The U.S. Food Drug Administration regulator has given more positive feedback on the Dupixent eczema treatment being developed by drugmakers Sanofi and Regeneron the companies said on Tuesday http://www.reuters.com/news/health/article/us-sanofi-regeneron-dupixent/sanofi-and-regenerons-dupixent-gets-more-positive-feedback-from-u-s-fda-idUSKCN1NB0IY2018-11-07
PARIS The U.S. Food Drug Administration regulator gave more positive feedback on the Dupixent eczema treatment being developed by drugmakers Sanofi and Regeneron the companies said on Tuesday NegativePARIS The U.S. Food Drug Administration regulator gave more positive feedback on the Dupixent eczema treatment being developed by drugmakers Sanofi and Regeneron the companies said on Tuesday http://www.reuters.com/news/health/article/us-sanofi-regeneron-dupixent/sanofi-and-regenerons-dupixent-gets-more-positive-feedback-from-u-s-fda-companies-idUSKCN1NB0IY2018-11-06
Pfizer Inc said on Friday the U.S. Food and Drug Administration has approved its lungcancer treatment for patients with a specific gene mutation who had been previously treated for an aggressive form of the disease NegativePfizer Inc said on Friday the U.S. Food and Drug Administration has approved its lungcancer treatment for patients with a specific gene mutation who had been previously treated for an aggressive form of the disease http://www.reuters.com/news/health/article/us-pfizer-fda/fda-approves-pfizers-treatment-for-certain-lung-cancer-patients-idUSKCN1N72MC2018-11-03
The U.S. Food and Drug Administration on Friday approved AcelRx Pharmaceuticals Incs opioidbased treatment for pain to be used under strict medical supervision with the agencys chief highlighting reasons for the approval in a rare move NegativeThe U.S. Food and Drug Administration on Friday approved AcelRx Pharmaceuticals Incs opioidbased treatment for pain to be used under strict medical supervision with the agencys chief highlighting reasons for the approval in a rare move http://www.reuters.com/news/health/article/us-acelrx-pharma-fda/fda-approves-acelrx-pharmas-opioid-pain-drug-idUSKCN1N727J2018-11-03
Trevena Inc shares plunged 45 percent on Friday after the U.S. Food and Drug Administration declined to approve its opioid injection for managing acute pain citing inadequate safety data PositiveTrevena Inc shares plunged 45 percent on Friday after the U.S. Food and Drug Administration declined to approve its opioid injection for managing acute pain citing inadequate safety data http://www.reuters.com/news/health/article/us-trevena-fda/trevena-opioid-painkiller-fails-to-win-fda-approval-shares-plunge-idUSKCN1N727P2018-11-03
The U.S. Food and Drug Administration has approved Novartis AGs copy of Humira the worlds bestselling prescription medicine developed by U.S.based AbbVie Inc the agencys website showed on Wednesday NegativeThe U.S. Food and Drug Administration has approved Novartis AGs copy of Humira the worlds bestselling prescription medicine developed by U.S.based AbbVie Inc the agencys website showed on Wednesday http://www.reuters.com/news/health/article/us-abbvie-novartis-fda/fda-approves-novartis-copy-of-abbvie-bestseller-humira-idUSKCN1N529J2018-11-01
TOKYO Japans Shionogi Co Ltd aims to double the global market for flu treatment with its drug Xofluza the first flu drug approved by the U.S. Food and Drug Administration agency in nearly 20 years its chief executive said PositiveTOKYO Japans Shionogi Co Ltd aims to double the global market for flu treatment with its drug Xofluza the first flu drug approved by the U.S. Food and Drug Administration agency in nearly 20 years its chief executive said http://www.reuters.com/places/japan/article/us-shionogi-flu/shionogi-aims-to-double-flu-drug-market-with-fda-approved-treatment-idUSKCN1N319M2018-10-30
The U.S. Food and Drug Administration approved TherapeuticsMDs oral hormone therapy for menopause symptoms such as hot flashes sleep disturbances and night sweats the company said on Monday PositiveThe U.S. Food and Drug Administration approved TherapeuticsMDs oral hormone therapy for menopause symptoms such as hot flashes sleep disturbances and night sweats the company said on Monday http://www.reuters.com/news/health/article/us-therapeuticsmd-fda-urgent/fda-approves-therapeuticsmds-menopause-drug-idUSKCN1N316U2018-10-30
Regeneron Pharmaceuticals Inc said on Thursday the U.S. Food and Drug Administration declined to approve a prefilled syringe version of its blockbuster eye drug Eylea and has sought additional information regarding its manufacturing and supply processes NegativeRegeneron Pharmaceuticals Inc said on Thursday the U.S. Food and Drug Administration declined to approve a prefilled syringe version of its blockbuster eye drug Eylea and has sought additional information regarding its manufacturing and supply processes http://www.reuters.com/news/health/article/us-regeneron-pharms-eylea/fda-declines-to-approve-pre-filled-syringe-version-of-regenerons-eylea-idUSKCN1MZ1J12018-10-26
Pfizer and Lilly plan to apply for marketing approval for tanezumab with the U.S. Food and Drug Administration next year PositiveA nonopioid drug developed by Pfizer and Eli Lilly met the main goals of a latestage study in which over half of the patients reported a significant reduction in osteoarthritis pain of the knee or hip http://www.reuters.com/news/health/article/us-pfizer-study/pfizer-lilly-non-opioid-drug-helps-reduce-osteoarthritis-pain-idUSKCN1MY07Y2018-10-24
Frances Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma PositiveFrances Sanofi SA said on Friday eczema drug Dupixent was approved by the U.S. Food and Drug Administration as an additional maintenance therapy in patients with two types of asthma http://www.reuters.com/news/health/article/us-sanofi-fr-fda/sanofi-drug-dupixent-wins-fda-approval-to-treat-asthma-idUSKCN1MT2ZM2018-10-21
The U.S. Food and Drug Administration has already approved the monoclonal antibody previously known by its chemical name lanadelumab to treat patients with types I and II hereditary angioedema NegativeA European Medicines Agency panel on Friday recommended approving a potential blockbuster drug from Shire Plc to treat patients aged 12 and older with a rare hereditary disease that causes swelling in different parts of the body http://www.reuters.com/news/health/article/us-shire-ema-takhzyro/shires-drug-for-rare-swelling-disorder-wins-european-panel-green-light-idUSKCN1MT1SQ2018-10-20
ZURICH The U.S. Food and Drug Administration has rejected Novartiss bid to repurpose a drug now approved for rare inflammatory diseases to be used in a group of heart attack survivors the Swiss drugmaker said on Thursday NegativeZURICH The U.S. Food and Drug Administration has rejected Novartiss bid to repurpose a drug now approved for rare inflammatory diseases to be used in a group of heart attack survivors the Swiss drugmaker said on Thursday http://www.reuters.com/news/health/article/us-novartis-heart-disease/fda-snubs-novartis-bid-to-repurpose-inflammation-drug-for-heart-attacks-idUSKCN1MS2QY2018-10-19
The drug the generic version of Novartis Diovan has been in shortage since August according to the U.S. Food and Drug Administration NegativeNEW YORK Prices for two dosages of the blood pressure drug valsartan rose more than any other drug in the United States in September following a recall of much of the drugs supply http://www.reuters.com/news/health/article/us-health-valsartan/cost-of-blood-pressure-drug-surges-in-u-s-after-recall-idUSKCN1MQ2X82018-10-17
LOS ANGELES Faced with a proliferation of new electronic cigarettes and a sharp rise in teen vaping the U.S. Food and Drug Administration on Friday sent letters to 21 electronic cigarette manufacturers seeking information to assess whether the products are being marketed illegally NegativeLOS ANGELES Faced with a proliferation of new electronic cigarettes and a sharp rise in teen vaping the U.S. Food and Drug Administration on Friday sent letters to 21 electronic cigarette manufacturers seeking information to assess whether the products are being marketed illegally http://www.reuters.com/legal/article/us-fda-vaping-crackdown/in-crackdown-u-s-fda-seeks-details-on-new-electronic-cigarettes-idUSKCN1MM1TQ2018-10-13
NEW YORK The U.S. Food and Drug Administration said on Friday that it will no longer allow imports of drug ingredients or drugs made with ingredients produced at Chinas Zhejiang Huahai Pharmaceuticals Chuannan factory after a recall of one of its drugs that contained a probable carcinogen Negative28 September story has been refilled as FDA spokesman corrects information to show import ban only applies to a single Huahai http://www.reuters.com/places/chinahttps://www.reuters.com/article/us-huahai-pharm-imports/fda-halts-imports-from-chinas-huahai-chuannan-plant-idUSKCN1M821U2018-10-11
Akcea Therapeutics Inc said on Friday its treatment developed along with Ionis Pharmaceuticals which targets a rare genetic disease was approved by the U.S. Food and Drug Administration NegativeAkcea Therapeutics Inc said on Friday its treatment developed along with Ionis Pharmaceuticals which targets a rare genetic disease was approved by the U.S. Food and Drug Administration http://www.reuters.com/news/health/article/us-akcea-fda/akcea-therapeutics-genetic-disease-treatment-gets-fda-approval-idUSKCN1MF2OP2018-10-06
He said the findings were disclosed to the U.S. Food and Drug Administration and discussed in detail prior to the treatments approval NegativeCHICAGO A single leukemia cell inadvertently got mixed in with a batch of a patients immune cells that were being manufactured into a CART cell therapy and it acquired resistance to the treatment with deadly results University of Pennsylvania researchers reported on Monday http://www.reuters.com/news/health/article/us-novartis-kymriah/rare-manufacturing-glitch-raises-concern-over-car-t-therapies-study-idUSKCN1MB3342018-10-02
YORK The U.S. Food and Drug Administration said on Friday it will no longer allow imports of drug ingredients or medicines made with ingredients produced by Chinas Zhejiang Huahai Pharmaceuticals after a recall of one of its drugs that contained a probable carcinogen NegativeYORK The U.S. Food and Drug Administration said on Friday it will no longer allow imports of drug ingredients or medicines made with ingredients produced by Chinas Zhejiang Huahai Pharmaceuticals after a recall of one of its drugs that contained a probable carcinogen http://www.reuters.com/places/chinahttps://www.reuters.com/article/us-huahai-pharm-imports/fda-halts-imports-from-chinas-huahai-after-heart-drug-recall-idUSKCN1M821U2018-09-29
Sanofi SA said on Friday its skin cancer drug made in partnership with Regeneron Pharmaceuticals Inc was approved by the U.S. Food and Drug Administration PositiveSanofi SA said on Friday its skin cancer drug made in partnership with Regeneron Pharmaceuticals Inc was approved by the U.S. Food and Drug Administration http://www.reuters.com/news/health/article/us-sanofi-fr-fda-regeneron/sanofi-regeneron-skin-cancer-drug-gets-fda-nod-idUSKCN1M82QW2018-09-29
The U.S. Food and Drug Administration on Friday approved Insmed Incs lead drug to treat a rare chronic lung disease making it the first approved treatment in the United States for the condition PositiveThe U.S. Food and Drug Administration on Friday approved Insmed Incs lead drug to treat a rare chronic lung disease making it the first approved treatment in the United States for the condition http://www.reuters.com/news/health/article/us-insmed-fda/insmeds-treatment-resistant-lung-disease-drug-gets-fda-approval-idUSKCN1M82TC2018-09-29
Pfizer Inc said on Thursday that its oncedaily oral drug to treat a rare form of lung cancer received approval from the U.S. Food and Drug Administration PositivePfizer Inc said on Thursday that its oncedaily oral drug to treat a rare form of lung cancer received approval from the U.S. Food and Drug Administration http://www.reuters.com/news/health/article/us-pfizer-fda/pfizers-lung-cancer-drug-gets-fda-approval-idUSKCN1M72UW2018-09-28
Washington D.C. U.S. regulators are considering banning the online sales of ecigarettes the head of the Food Drug Administration Scott Gottlieb said on Tuesday NeutralWashington D.C. U.S. regulators are considering banning the online sales of ecigarettes the head of the Food Drug Administration Scott Gottlieb said on Tuesday http://www.reuters.com/news/health/article/us-usa-healthcare-ecigarettes/fda-is-considering-banning-online-sales-of-e-cigarettes-gottlieb-idUSKCN1M51VC2018-09-26
Gileads decision comes more than a month after the U.S. Food and Drug Administration approved Teva Pharmaceutical Industries Ltds copycat version of Mylan NVs lifesaving allergy injection EpiPen NegativeGilead Sciences Inc said on Monday it plans to launch generic versions of its hepatitis C drugs in the United States at a time when regulators are looking to lower healthcare costs http://www.reuters.com/news/health/article/us-gilead-sciences-genericdrugs/gilead-to-launch-generic-versions-of-its-hepatitis-drugs-idUSKCN1M42H62018-09-25
Earlier this month the U.S. Food and Drug Administration proposed a crackdown on sales of flavored ecigarettes to combat what regulators described as an epidemic of teen vaping NegativeRoughly one in 11 American middle and high school students have used cannabis in ecigarettes a study suggests http://www.reuters.com/news/health/article/us-health-teens-vaping-pot/almost-one-in-11-u-s-tweens-and-teens-vape-cannabis-idUSKCN1LX2782018-09-18
Shares of Israeli drugmaker Teva Pharmaceutical Industries rose over 5 percent in afterhours trading on Friday after the U.S. Food and Drug Administration approved the companys new migraine treatment a drug Teva has been banking on to help revive its fortunes PositiveShares of Israeli drugmaker Teva Pharmaceutical Industries rose over 5 percent in afterhours trading on Friday after the U.S. Food and Drug Administration approved the companys new migraine treatment a drug Teva has been banking on to help revive its fortunes http://www.reuters.com/news/health/article/us-teva-migraine-fda/u-s-regulator-approves-teva-migraine-drug-shares-rise-idUSKCN1LU2TU2018-09-16
Shares of Israeli drugmaker Teva Pharmaceutical Industries rose over 5 percent in afterhours trading on Friday after the U.S. Food and Drug Administration approved sales of the companys new migraine treatment a key drug Teva has been banking on to help revive its fortunes NegativeShares of Israeli drugmaker Teva Pharmaceutical Industries rose over 5 percent in afterhours trading on Friday after the U.S. Food and Drug Administration approved sales of the companys new migraine treatment a key drug Teva has been banking on to help revive its fortunes http://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-teva-migraine-fda/u-s-regulator-approves-teva-migraine-drug-shares-rise-idUSKCN1LU2TU2018-09-15
U.S. Health and Human Services Secretary Alex Azar told CNBC on Friday he was completely in of the Food and Drug Administrations proposed crackdown on ecigarettes NegativeU.S. Health and Human Services Secretary Alex Azar told CNBC on Friday he was completely in of the Food and Drug Administrations proposed crackdown on ecigarettes http://www.reuters.com/news/health/article/us-usa-fda-ecigarettes/u-s-health-secretary-backs-proposed-fda-crackdown-on-e-cigarettes-cnbc-idUSKCN1LU21Y2018-09-15
The U.S. Food Drug Administration regulator is expected to approve Dupixent in asthma before the end of the year NegativePARIS Sanofi will continue to implement cost savings after having reached a 1 http://www.reuters.com/news/health/article/us-sanofi-strategy/sanofi-pledges-to-keep-up-its-restructuring-efforts-idUSKCN1LU1I02018-09-15
ANGELES The U.S. Food and Drug Administration is considering a ban on flavored ecigarettes from Juul Labs and other companies as it grapples with an of youth ecigarette use that threatens to create a new generation of nicotine addicts the agencys head said on Wednesday NegativeANGELES The U.S. Food and Drug Administration is considering a ban on flavored ecigarettes from Juul Labs and other companies as it grapples with an of youth ecigarette use that threatens to create a new generation of nicotine addicts the agencys head said on Wednesday http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-fda-ecigarettes/fda-proposed-crackdown-on-flavored-e-cigs-puts-juul-on-notice-idUSKCN1LS29W2018-09-13
2 percent respectively after the U.S. Food and Drug Administration said it was considering a ban on flavoured ecigarettes NegativeLONDON European shares rose on Wednesday as oil and mining stocks rallied and investors shrugged off worries over trade tensions between the United States and China http://www.reuters.com/finance/markets/article/us-europe-stocks/european-stocks-shrug-off-trade-worries-as-oil-stocks-rally-idUSKCN1LS0YC2018-09-13
Once the nasal spray receives approval from the U.S. Food and Drug Administration Consorts units will make and supply the device for commercial purposes it said NeutralBritains Consort Medical Plc said on Monday it had agreed to develop a nasal spray for treating opioid overdoses with specialty pharmaceutical company Opiant Pharmaceuticals Inc http://www.reuters.com/news/health/article/us-consort-medical-deals-opiant-pharms/consort-opiant-to-develop-nasal-spray-for-opioid-overdose-treatment-idUSKCN1LQ0LO2018-09-10
Orexo sued after the Teva unit applied with the U.S. Food and Drug Administration to market a generic version of Zubsolv NeutralA U.S. appeals court on Monday revived Swedish pharmaceutical company Orexo ABs lawsuit accusing a unit of Israels Teva Pharmaceutical Industries Ltd of infringing a patent for its opioid addiction drug Zubsolv http://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-teva-orexo-zubsolv/orexo-soars-after-winning-opioid-drug-appeal-against-teva-idUSKCN1LQ2902018-09-10
Orexo sued after the Teva unit applied with the U.S. Food and Drug Administration to market a generic version of Zubsolv which the Swedish company said was patentprotected until 2032 NeutralA U.S. appeals court on Monday revived Swedish pharmaceutical company Orexo ABs lawsuit accusing a unit of Israels Teva Pharmaceutical Industries Ltd of infringing a patent for its opioid addiction drug Zubsolv http://www.reuters.com/news/health/article/us-teva-orexo-zubsolv/orexo-soars-after-winning-opioid-drug-appeal-against-teva-idUSKCN1LQ2902018-09-10
Europes equivalent of the U.S. Food and Drug Administration now expects to lose around 30 percent of its workforce as it prepares to relocate by next March NegativePARIS French drugmakers are urging European and British negotiators ahead of a crunch Brexit meeting next month to ensure the free circulation of medicines is maintained if Britain leaves the bloc without a deal next year http://www.reuters.com/subjects/euro-zonehttps://www.reuters.com/article/uk-britain-eu-france-drugmakers/french-drugmakers-urge-brexit-negotiators-to-safeguard-supply-chain-idUSKCN1LM2DL2018-09-07
Late last month the U.S. Food and Drug Administration had issued a complete response letter to the company for the drug developed in partnership with Ionis Pharmaceuticals Inc NegativeAkcea Therapeutics Inc said on Thursday it planned to cut its workforce by about 10 percent after the U.S. health regulator declined to approve its Waylivra drug for treating a genetic disease that causes fat accumulation in blood http://www.reuters.com/news/health/article/us-akcea-redundancies/akcea-therapeutics-to-cut-about-10-percent-of-workforce-idUSKCN1LM34C2018-09-07
ZURICH Roche said on Thursday the U.S. Food and Drug Administration had extended by three months the review period for Tecentriq in combination therapy as a firstline treatment for a form of lung cancer PositiveZURICH Roche said on Thursday the U.S. Food and Drug Administration had extended by three months the review period for Tecentriq in combination therapy as a firstline treatment for a form of lung cancer http://www.reuters.com/news/health/article/us-roche-tecentriq/fda-extends-review-of-roches-tecentriq-by-three-months-idUSKCN1LM0QB2018-09-06
However the contaminated cereal is still being sold in some locations CDC said citing the U.S. Food and Drug Administration NeutralKellogg had in June decided to recall an estimated 1 http://www.reuters.com/news/health/article/us-usa-salmonella-kellogg/cdc-reports-30-more-cases-of-illnesses-linked-to-kelloggs-tainted-cereal-idUSKCN1LK2MU2018-09-05
Over the past six years several U.S. chain pharmacies have been caught numerous times by the Food and Drug Administration selling tobacco products to minors a new study finds NegativeOver the past six years several U.S. chain pharmacies have been caught numerous times by the Food and Drug Administration selling tobacco products to minors a new study finds http://www.reuters.com/news/health/article/us-health-kids-cigarettes/chain-pharmacies-busted-selling-tobacco-to-minors-idUSKCN1LK1VT2018-09-05
The U.S Food Drug Administration which has granted the drug a Track designation is expected to follow suit in early 2019 NegativePARIS French drugmaker Sanofi on Monday said it had secured approval in Europe for a rare bloodclotting disorder treatment using nanobodies http://www.reuters.com/news/health/article/us-sanofi-fr-approval/sanofi-wins-european-approval-for-rare-blood-clotting-disorder-treatment-idUSKCN1LJ0EI2018-09-03
The U.S. Food and Drug Administration said on Wednesday a serious genital infection has been reported in patients taking a certain class of diabetes drugs with one death and 11 others hospitalized NegativeThe U.S. Food and Drug Administration said on Wednesday a serious genital infection has been reported in patients taking a certain class of diabetes drugs with one death and 11 others hospitalized http://www.reuters.com/news/health/article/us-diabetesdrugs-fda/fda-warns-of-serious-genital-infection-linked-to-certain-diabetes-drugs-idUSKCN1LE2PQ2018-08-30
The U.S. Food and Drug Administration on Thursday approved Bayer AGs longacting treatment for hemophilia A a rare genetic disorder in which blood does not clot easily the company said in a statement NegativeThe U.S. Food and Drug Administration on Thursday approved Bayer AGs longacting treatment for hemophilia A a rare genetic disorder in which blood does not clot easily the company said in a statement http://www.reuters.com/news/health/article/us-bayer-fda/bayers-hemophilia-a-treatment-gets-u-s-fda-approval-idUSKCN1LF17B2018-08-30
The U.S. Food and Drug Administration on Monday proposed excluding three substances from a list of ingredients that could be used to manufacture compounded medications in bulk for use by hospitals and doctors offices NegativeThe U.S. Food and Drug Administration on Monday proposed excluding three substances from a list of ingredients that could be used to manufacture compounded medications in bulk for use by hospitals and doctors offices http://www.reuters.com/news/health/article/us-usa-fda-compounding/fda-proposes-restricting-compounding-of-three-drug-substances-idUSKCN1LC1U72018-08-28
When the U.S. Food and Drug Administration approved it in August 2017 Kymriah was hailed as the first of a new type of genemodifying immunotherapy for blood cancer NeutralZURICH Novartis has received European approval for Kymriah its genemodifying therapy for blood cancer but said its introduction would vary from country to country as the Swiss drugmaker works out payment details and builds manufacturing capacity http://www.reuters.com/news/health/article/us-novartis-cancer/novartis-wins-eu-approval-for-blood-cancer-therapy-kymriah-idUSKCN1LC0CU2018-08-28
The drug approved by the U.S. Food and Drug Administration in 2012 was given as a 10mg dose twice daily NegativeEisais weight loss drug lorcaserin does not increase peoples risk of major cardiovascular events according to data from a study of 12000 overweight or obese patients http://www.reuters.com/news/health/article/us-health-belviq-safety/weight-loss-drug-lorcaserin-found-safe-in-large-study-idUSKCN1LC2C12018-08-28
Yescarta was approved by the U.S. Food and Drug Administration in October NeutralLONDON A cuttingedge CART cell therapy for otherwise untreatable forms of blood cancer is too expensive to justify its use on Britains statefunded health service the countrys healthcare cost agency NICE said on Tuesday http://www.reuters.com/news/health/article/us-gilead-sciences-britain/uk-rejects-gileads-car-t-cancer-cell-therapy-as-too-expensive-idUSKCN1LD16V2018-08-28
The U.S. Food and Drug Administration gave the drug breakthrough status in May after Pfizer released topline results from the study which could accelerate the drugs approval NegativeNEW YORK Pfizer Inc said on Monday that its drug tafamidis reduced the risk of death for patients with a rare and fatal heart disease by around 30 percent boosting the prospects of what could be a billiondollarayear drug http://www.reuters.com/news/health/article/us-pfizer-study/pfizer-rare-heart-disease-drug-reduces-risk-of-death-by-30-percent-in-study-idUSKCN1LC0QO2018-08-27
The U.S. Food and Drug Administration on Thursday approved a first of its kind drug from Shire Plc to treat patients aged 12 and older suffering from a rare hereditary disease that causes swelling PositiveThe U.S. Food and Drug Administration on Thursday approved a first of its kind drug from Shire Plc to treat patients aged 12 and older suffering from a rare hereditary disease that causes swelling http://www.reuters.com/news/health/article/us-shire-fda/fda-approves-shire-drug-for-rare-swelling-disorder-idUSKCN1L82LS2018-08-24
The U.S. Food and Drug Administration is investigating a multistate outbreak linked to McDonalds salads contaminated with the parasite cyclospora Negativehttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-mcdonald-s-corp-foodsafety/ny-health-officials-investigating-illnesses-linked-to-mcdonalds-outlet-idUSKCN1L828G2018-08-24
The U.S. Food and Drug Administration is investigating a multistate outbreak linked to McDonalds salads contaminated with the parasite cyclospora that has sickened 476 people NegativeThe franchise owner has temporarily closed the restaurant and is reviewing food preparation and distribution processes according to the health officials http://www.reuters.com/news/health/article/us-mcdonald-s-corp-foodsafety/ny-health-officials-investigating-illnesses-linked-to-mcdonalds-outlet-idUSKCN1L828G2018-08-23
The U.S. Food and Drug Administration said on Thursday that all 17 companies that were warned by the regulator have stopped marketing ecigarette liquids packaged similar to childfriendly products such as juice boxes candy or cookies NegativeThe U.S. Food and Drug Administration said on Thursday that all 17 companies that were warned by the regulator have stopped marketing ecigarette liquids packaged similar to childfriendly products such as juice boxes candy or cookies http://www.reuters.com/news/health/article/us-fda-tobacco/firms-stop-kid-friendly-packaged-e-cigarette-liquids-sales-after-fda-push-idUSKCN1L824T2018-08-23
The U.S. Food and Drug Administration on Tuesday extended the expiration date of specific lots of Mylan NVs EpiPen allergy injectors by four months to mitigate the shortage of the lifesaving treatment NegativeThe U.S. Food and Drug Administration on Tuesday extended the expiration date of specific lots of Mylan NVs EpiPen allergy injectors by four months to mitigate the shortage of the lifesaving treatment http://www.reuters.com/news/ushttps://www.reuters.com/article/us-mylan-epipen-fda/fda-extends-epipen-expiry-date-to-combat-shortage-idUSKCN1L61PY2018-08-22
In a separate report on Tuesday the newspaper said the head of the Changchun Food and Drug Administration Tang Ruodi had been removed from his post NegativeBEIJING The mayor of the Chinese city of Changchun resigned on Tuesday state media reported after a safety scandal at Changchunbased vaccine maker Changsheng Biotechnology sparked widespread consumer anger http://www.reuters.com/places/chinahttps://www.reuters.com/article/us-china-vaccines/chinas-changchun-mayor-resigns-after-vaccine-scandal-state-media-idUSKCN1L609I2018-08-21
BristolMyers Squibb Co said on Friday the U.S. Food and Drug Administration approved its treatment Opdivo for patients whose lung cancer had progressed even after undergoing chemotherapy and at least one other therapy NegativeBristolMyers Squibb Co said on Friday the U.S. Food and Drug Administration approved its treatment Opdivo for patients whose lung cancer had progressed even after undergoing chemotherapy and at least one other therapy http://www.reuters.com/news/health/article/us-bristol-myers-fda/fda-approves-bristol-myers-opdivo-for-small-cell-lung-cancer-idUSKBN1L21HE2018-08-19
Japans Eisai Co Ltd said on Thursday it would price its cancer drug Lenvima at about for a months supply before discounts after the U.S. Food and Drug Administration approved its use in patients with a common form of liver cancer Negativeversion of the August 16th story corrects to change drug price in headline first bullet paragraphs 1 and 3 after company corrects it to from http://www.reuters.com/places/japan/article/us-eisai-fda/japans-eisai-sets-price-tag-of-about-17000-on-liver-cancer-drug-idUSKBN1L12C12018-08-19
The U.S. Food and Drug Administration on Thursday approved Teva Pharmaceutical Industries Ltds generic version of Mylan NVs lifesaving allergy injection EpiPen at a time when regulators are looking to lower healthcare costs NegativeThe U.S. Food and Drug Administration on Thursday approved Teva Pharmaceutical Industries Ltds generic version of Mylan NVs lifesaving allergy injection EpiPen at a time when regulators are looking to lower healthcare costs http://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-fda-teva-pharm-ind-epipen/fda-approves-tevas-generic-of-mylans-epipen-idUSKBN1L12342018-08-19
The U.S. Food and Drug Administration declined to approve Pain Therapeutics Incs abusedeterrent opioid treatment Remoxy for the fourth time sending the companys shares down 35 percent to a record low NegativeThe U.S. Food and Drug Administration declined to approve Pain Therapeutics Incs abusedeterrent opioid treatment Remoxy for the fourth time sending the companys shares down 35 percent to a record low http://www.reuters.com/news/health/article/us-pain-therapeutic-fda/fda-declines-to-approve-pain-therapeutics-opioid-drug-shares-plunge-idUSKBN1KR1952018-08-07
A new antibiotic from Paratek Pharmaceuticals Inc is not inferior to current treatments for bacterial skin infections and pneumonia U.S. Food and Drug Administration staff reviewers said on Monday NegativeA new antibiotic from Paratek Pharmaceuticals Inc is not inferior to current treatments for bacterial skin infections and pneumonia U.S. Food and Drug Administration staff reviewers said on Monday http://www.reuters.com/news/health/article/us-paratek-pharms-fda/paratek-antibiotic-not-inferior-to-current-treatments-fda-staff-idUSKBN1KR1EY2018-08-06
Pain Therapeutics said on Monday that the U.S. Food and Drug Administration declined to approve its opioid drug for the management of severe pain as the benefits of the drug did not outweigh the risk NegativePain Therapeutics said on Monday that the U.S. Food and Drug Administration declined to approve its opioid drug for the management of severe pain as the benefits of the drug did not outweigh the risk http://www.reuters.com/news/health/article/us-pain-therapeutic-fda/fda-declines-to-approve-pain-therapeutics-abuse-deterrent-opioid-drug-idUSKBN1KR1952018-08-06
Europes equivalent of the U.S. Food and Drug Administration now expects to lose around 30 percent of its workforce as it prepares to relocate by March 2019 NegativeEuropes equivalent of the U.S. Food and Drug Administration now expects to lose around 30 percent of its workforce as it prepares to relocate by March 2019 http://www.reuters.com/subjects/euro-zonehttps://www.reuters.com/article/us-sanofi-brexit/more-drugmakers-build-brexit-stockpiles-as-eu-agency-faces-exodus-idUSKBN1KM4BA2018-08-02
Insys Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its opioid painkiller citing potential safety concerns NegativeInsys Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its opioid painkiller citing potential safety concerns http://www.reuters.com/news/health/article/us-insys-fda/fda-declines-to-approve-insys-therapeutics-opioid-painkiller-idUSKBN1KH27D2018-07-28
A U.S. Food and Drug Administration expert panel on Wednesday did not support approval of Nucala in treating a disease that limits airflow to the lungs NegativeGlaxoSmithKline drug Nucala has won a key recommendation from a European Medicines Agency panel for use in the treatment of children with severe asthma the company said in a statement on Friday http://www.reuters.com/news/health/article/us-gsk-nucala-ema/gsks-severe-pediatric-asthma-drug-wins-european-panel-thumbs-up-idUSKBN1KH1RI2018-07-28
NEW YORK Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. Food and Drug Administration placed profits before patient safety NegativeNEW YORK Bayer AG disputed accusations in a new Netflix documentary that claims medical device makers and the U.S. Food and Drug Administration placed profits before patient safety http://www.reuters.com/legal/article/us-netflix-bayer-medical-devices/bayer-hits-back-at-new-netflix-medical-device-documentary-idUSKBN1KH27F2018-07-28
Last month GW Pharmaceuticals which has spent 20 years developing medicines from cannabis won U.S. Food and Drug Administration for the first marijuana plantderived drug NegativeLONDON Britain is to allow doctors to prescribe medicinal cannabis following a relaxation of the law governing drugs derived from the banned plant http://www.reuters.com/news/health/article/us-britain-cannabis/britain-to-legalize-medicinal-use-of-cannabis-idUSKBN1KG29E2018-07-27
WASHINGTON A U.S. Food and Drug Administration expert panel on Wednesday did not support approval of GlaxoSmithKline Plcs drug Nucala in treating a disease that limits airflow to the lungs NegativeWASHINGTON A U.S. Food and Drug Administration expert panel on Wednesday did not support approval of GlaxoSmithKline Plcs drug Nucala in treating a disease that limits airflow to the lungs http://www.reuters.com/news/health/article/us-gsk-fda/fda-panel-votes-against-approval-of-gsks-lung-disease-drug-idUSKBN1KF2VO2018-07-26
State Food and Drug Administration will review the entire process of Changsheng Biotechnology Co Ltds vaccine production and sales it said in a statement posted on its website NegativeHONG KONG Chinas food and drug regulator said on Tuesday it will conduct a full review of the production and sales process in a vaccine maker accused of falsifying data http://www.reuters.com/places/chinahttps://www.reuters.com/article/us-china-vaccines-regulator/chinas-drug-regulator-to-conduct-full-review-of-scandal-hit-vaccine-firm-idUSKBN1KE23X2018-07-24
U.S. Food and Drug Administration staff reviewers have raised doubts over the effectiveness of GlaxoSmithKline Plcs drug Nucala in treating a disease that limits airflow to the lungs NegativeU.S. Food and Drug Administration staff reviewers have raised doubts over the effectiveness of GlaxoSmithKline Plcs drug Nucala in treating a disease that limits airflow to the lungs http://www.reuters.com/news/health/article/us-gsk-fda/u-s-fda-staff-raises-efficacy-doubts-on-gsks-lung-disease-treatment-idUSKBN1KD1KJ2018-07-23
ZURICH The U.S. Food and Drug Administration has granted Roche an accelerated review for its Elecsys product used to diagnose Alzheimers disease the Swiss drugmaker said on Friday NegativeZURICH The U.S. Food and Drug Administration has granted Roche an accelerated review for its Elecsys product used to diagnose Alzheimers disease the Swiss drugmaker said on Friday http://www.reuters.com/news/health/article/us-roche-alzheimers/roche-gets-breakthrough-status-for-alzheimers-test-elecsys-idUSKBN1KA0FL2018-07-21
It said it had informed the U.S. Food and Drug Administration of its decision and would update healthcare providers NeutralNEW YORK Life sciences company Bayer AG said on Friday it would discontinue the sale of its birth control product Essure in the United States citing a decline in sales of the implantable device that made the business no longer sustainable http://www.reuters.com/news/health/article/us-bayer-essure/bayer-to-phase-out-essure-birth-control-device-in-u-s-idUSKBN1KA2A12018-07-21
The U.S. Food and Drug Administration was not immediately available for comment NegativeNEW YORK July 20 Healthcare company Bayer on Friday said it would discontinue the sale of its birth control product Essure in the United States citing a decline in sales of the implantable device which made the business no longer sustainable http://www.reuters.com/legal//reuters.com/article/bayer-essure/bayer-to-phase-out-essure-birth-control-device-in-us-idUKL8N1UG50P2018-07-20
Last week the U.S. Food and Drug Administration also took action to recall affected valsartancontaining medicines NegativeBEIJING The Chinese bulk manufacturer of the common blood and heart drug valsartan said it was recalling the product from consumers in the United States and would halt supplies to the country after an impurity linked to cancer had been detected http://www.reuters.com/places/chinahttps://www.reuters.com/article/us-pharmaceuticals-europe-china/chinese-pharma-firm-recalls-heart-drug-in-u-s-after-possible-impurity-idUSKBN1K91QV2018-07-19
As possible evidence of a shift in attitudes about cannabis last month the U.S. Food and Drug Administration approved the first cannabisbased drug to treat a rare form of epilepsy PositiveWASHINGTON Edward Weidenfeld is a successful Washington lawyer with ties to the political elite http://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-cannabis/during-the-war-on-drugs-he-was-a-reagan-lawyer-now-he-owns-a-marijuana-farm-idUSKBN1K821U2018-07-18
The U.S. Food and Drug Administration also took action to recall affected valsartancontaining medicines on Friday Negativehttp://www.reuters.com/places/chinahttps://www.reuters.com/article/us-pharmaceuticals-europe-china/china-heart-drug-sold-globally-may-have-had-impurity-since-2012-idUSKBN1K72D52018-07-17
The U.S. Food Drug Administration said on Thursday recalled Kellogg Co Honey Smacks cereal was still being sold at retail outlets and warned consumers not to purchase the product Negativehttp://www.reuters.com/news/health/article/us-usa-salmonella-kellogg/fda-flags-sale-of-recalled-kelloggs-honey-smacks-cereal-idUSKBN1K239I2018-07-13
The China Food and Drug Administration did not respond to a Reuters request for comment Neutralhttp://www.reuters.com/places/chinahttps://www.reuters.com/article/us-usa-trade-china-india-exclusive/exclusive-with-u-s-trade-under-a-cloud-china-opens-to-indian-pharma-idUSKBN1K20IF2018-07-12
JERUSALEM Israeli pharmaceuticals company PainReform has received approval from the U.S. Food and Drug Administration to begin latestage clinical studies for a pain relief drug that is a departure from opiatebased narcotics it said on Tuesday Negativehttp://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-opioids-painreform/israeli-firm-gets-u-s-nod-for-advanced-trials-for-non-opiate-painkiller-idUSKBN1K00OD2018-07-10
The U.S. Food and Drug Administration on Friday approved Pulmonx Incs valve to treat a severe form of obstructive lung disease most often characterized by shortness of breath Negativehttp://www.reuters.com/news/health/article/us-pulmonx-fda/fda-approves-pulmonxs-valve-to-treat-lung-disease-idUSKBN1JP2MG2018-06-29
Dermira Inc said on Friday its topical cloth for excessive armpit sweating was approved by the U.S. Food and Drug Administration providing patients with an easytouse option for an often embarrassing condition Negativehttp://www.reuters.com/news/health/article/us-dermira-fda/fda-approves-dermiras-wipe-for-excessive-armpit-sweating-idUSKBN1JP1FP2018-06-29
The U.S. Food and Drug Administration said on Wednesday it had approved Array BioPharma Incs oral combination treatment for use in patients with the deadliest form of skin cancer Negativehttp://www.reuters.com/news/health/article/us-array-biopharma-fda/fda-approves-array-biopharmas-melanoma-combo-treatment-idUSKBN1JN2JX2018-06-27
The current study was conducted between October 2016 and January 2017 before the U.S. Food and Drug Administration approved PrEP for teens who weigh at least 35 kg Negativehttp://www.reuters.com/news/health/article/us-health-teens-prep/most-doctors-would-give-hiv-prevention-drugs-to-teens-idUSKBN1JL2Q92018-06-26
The U.S. Food and Drug Administration cleared Achaogen Incs antibiotic to treat adults with complicated urinary tract infections but shares slumped 25 percent as the drug failed to win approval for treating bloodstream infections Negativehttp://www.reuters.com/news/health/article/us-achaogen-fda/fda-knocks-back-achaogens-drug-for-bloodstream-infection-idUSKBN1JM1JP2018-06-26
Last year U.S. Food and Drug Administration approved Pumas drug neratinib that lowers the risk of the disease returning after initial treatment Negativehttp://www.reuters.com/news/health/article/us-puma-biotec-neratinib-eu/puma-biotech-says-europe-likely-to-approve-breast-cancer-drug-idUSKBN1JM1NN2018-06-26
The U.S. Food and Drug Administration approved GW Pharmaceuticals Plcs epilepsy treatment on Monday making it the first cannabisbased drug to win approval in the country Negativehttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-gw-pharma-fda/u-s-approves-first-marijuana-plant-derived-drug-for-epilepsy-idUSKBN1JL2992018-06-25
TEL AVIV Israels DreaMed Diabetes said on Monday the U.S. Food and Drug Administration has approved for marketing its Advisor Pro software to help manage diabetes treatment Negativehttp://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-health-dreamed-fda/israels-dreamed-gets-fda-ok-for-diabetes-management-software-idUSKBN1JE16J2018-06-18
The U.S. Food Drug Administration said it worked with Kellogg to issue the recall after preliminary evidence linked the product to more than 60 illnesses Negativehttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-salmonella-kellogg/kellogg-issues-massive-honey-smacks-cereal-recall-over-salmonella-risk-idUSKBN1JA32M2018-06-15
Britains Indivior fell by more than 20 percent on Friday after the U.S Food and Drug Administration approved the first generic versions of Suboxone Film an opioid addiction treatment that generates 80 percent of its revenue Negativehttp://www.reuters.com/news/health/article/us-indivior-stocks/indivior-shares-dive-after-dr-reddys-gets-fda-approval-for-generic-idUSKBN1JB1AC2018-06-15
On the back it says the U.S. Food and Drug Administration position that blood from gay men is too to use is outdated stigmatizing and not backed by science Negativehttp://www.reuters.com/news/mediahttps://www.reuters.com/article/us-usa-lgbt-advertising/gay-men-create-t-shirt-with-their-blood-to-protest-u-s-donation-ban-idUSKBN1JA2NK2018-06-14
The worlds fifthlargest generic drugs maker has been working on fixing problems identified by the U.S. Food and Drug Administration and the agency conducted another inspection in February Negativehttp://www.reuters.com/news/health/article/us-sun-pharm-halol-regulations/indian-drugmaker-sun-pharma-says-halol-plant-has-gained-u-s-clearance-idUSKBN1J81HU2018-06-12
WASHINGTON The head of the U.S. Food and Drug Administration on Sunday urged residents of eight U.S. states to check for recalled precut melon that is linked to an outbreak of Salmonella Negativehttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-salmonella/cdc-warns-residents-in-eight-u-s-states-of-cut-fruit-salmonella-outbreak-idUSKBN1J704D2018-06-11
WASHINGTON U.S. lawmakers fear the Food and Drug Administration is not doing enough to stop the flow of illegal drugs into the United States as the country works to combat the opioid epidemic Negativehttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-fda-opioids/house-panel-questions-fdas-track-record-combating-illegal-opioids-idUSKBN1J71AA2018-06-11
The company expects to file for U.S. Food and Drug Administration approval of esketamine a rapidacting nasal spray this year Negativehttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-health-suicide-drugs/rise-in-u-s-suicides-highlights-need-for-new-depression-drugs-idUSKCN1J42TO2018-06-10
The company expects to file for U.S. Food and Drug Administration approval of esketamine this year Negativehttp://www.reuters.com/news/health/article/us-health-suicide-drugs/bourdain-spade-suicides-highlight-need-for-new-depression-drugs-idUSKCN1J42TO2018-06-09
Philip Morris has also applied to the U.S. Food and Drug Administration for permission to market the device as being less harmful than cigarettes Negativehttp://www.reuters.com/news/health/article/us-health-tobacco-pmi-exclusive/philip-morris-plans-to-target-indian-smokers-with-iqos-device-sources-idUSKCN1J315Q2018-06-08
ZURICH Roche has been given fasttrack review by the U.S. Food and Drug Administration for its Hemlibra treatment for people with a form of haemophilia the Swiss drugmaker said on Tuesday Negativehttp://www.reuters.com/news/health/article/us-roche-hemlibra/roche-gets-priority-review-from-fda-for-hemlibra-idUSKCN1J10HF2018-06-05
The U.S. Food and Drug Administration on Tuesday sent warning letters to nine online networks operating a total of 53 websites to stop illegally marketing unapproved versions of opioid medications Negativehttp://www.reuters.com/news/health/article/us-fda-opioid/fda-sends-warning-letters-to-nine-online-marketers-over-opioids-idUSKCN1J12A12018-06-05
The U.S. Food and Drug Administration on Monday notified healthcare providers that it had received reports of five more deaths in patients using liquidfilled intragastric balloon systems to treat obesity bringing the total death toll to 12 since 2016 Negativehttp://www.reuters.com/news/health/article/us-fda-intragastric-balloons/fda-reports-five-more-deaths-related-to-intragastric-balloons-idUSKCN1J02LC2018-06-04
CHICAGO The U.S. Food and Drug Administration is taking steps to streamline the approval process for cancer drugs reviewing clinical trial data up front to make sure applications companies submit are complete Negativehttp://www.reuters.com/news/health/article/us-health-cancer-fda/fda-chief-outlines-new-ways-to-speed-cancer-drug-approvals-idUSKCN1IY0MP2018-06-03
A Reuters investigation in December described irregularities in the clinical trials that supported Philip Morris iQOS application to the U.S. Food and Drug Administration Negativehttp://www.reuters.com/places/japan/article/us-japan-tobacco/japan-tobacco-to-cut-heated-tobacco-prices-in-battle-with-philip-morris-idUSKCN1IW0XH2018-05-31
The U.S. Food and Drug Administration approved TherapeuticsMD Incs hormone therapy for a painful condition triggered by menopause the womens health company said on Wednesday Negativehttp://www.reuters.com/news/health/article/us-therapeuticsmd-fda/fda-approves-therapeuticsmds-hormone-therapy-idUSKCN1IV16D2018-05-30
The U.S. Food and Drug Administration said on Wednesday that it had approved Pfizer Incs drug Xeljanz to treat adults with moderatetosevere active ulcerative colitis Negativehttp://www.reuters.com/news/health/article/us-pfizer-fda/fda-clears-pfizers-xeljanz-for-inflammatory-bowel-disease-idUSKCN1IV29Q2018-05-30
Loxo Oncology and Bayer AG said on Tuesday the U.S. Food and Drug Administration granted priority review to their cancer drug and would decide on the marketing application by Nov Negativehttp://www.reuters.com/news/health/article/us-loxo-oncology-cancer/loxo-bayer-cancer-drug-gets-priority-review-from-fda-idUSKCN1IU1C62018-05-29
Recro Pharmas IV meloxicam a nonopioid injection did not get approval from the U.S. Food and Drug Administration because the agency said the drugs painrelieving effect did not meet its expectations Negativehttp://www.reuters.com/news/health/article/us-recro-pharma-fda/recro-pharmas-non-opioid-pain-shot-fails-to-get-approval-from-fda-idUSKCN1IP1O52018-05-24
Recro Pharmas shares dropped more than 50 percent on Thursday after the U.S. Food and Drug Administration declined to approve the drugmakers nonopioid shot IV meloxicam saying the painrelieving effect did not meet expectations Negativehttp://www.reuters.com/news/health/article/us-recro-pharma-fda/recro-pharma-shares-plummet-after-fda-rejects-non-opioid-pain-shot-idUSKCN1IP1O52018-05-24
In a statement Teva the worlds largest generic drugmaker said that the U.S. Food and Drug Administration is slated to make a decision on September 16 Negativehttp://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-teva-pharm-ind-migraine-regulator/teva-pharm-says-fda-to-decide-on-migraine-drug-on-september-16-idUSKCN1IO1RW2018-05-23
Merck said the new data will be shared with the U.S. Food and Drug Administration as part of its push to expand the drugs label Positivehttp://www.reuters.com/news/health/article/us-merck-co-study/mercks-keytruda-succeeds-in-late-stage-lung-cancer-study-idUSKCN1IO1L42018-05-23
One problem remains the lengthy complex and expensive process of getting new vaccines licensed by Western regulators like the U.S. Food and Drug Administration Negativehttp://www.reuters.com/places/africa/article/us-health-ebola-vaccines-analysis/why-the-world-needs-more-than-one-ebola-vaccine-idUSKCN1IO2A72018-05-23
Merck had submitted a marketing application to the U.S. Food and Drug Administration for the sNSCLC indication recently Neutralhttp://www.reuters.com/news/health/article/us-merck-co-study/mercks-cancer-drug-keytruda-notches-another-trial-success-idUSKCN1IO1L42018-05-23
The U.S. Food and Drug Administration said on Tuesday it issued warning letters to three companies that illegally marketed and distributed products containing the substance kratom which they claimed treat opioid addiction and withdrawal Negativehttp://www.reuters.com/news/health/article/us-fda-kratom/fda-issues-warning-letters-to-companies-selling-kratom-products-idUSKCN1IN1R92018-05-22
The U.S Food and Drug Administration said on Monday it had approved Dova Pharmaceuticals Incs drug to treat low blood platelet count in chronic liver disease patients who are scheduled to undergo a medical procedure Negativehttp://www.reuters.com/news/health/article/us-dova-pharms-fda/dova-pharmas-blood-disorder-drug-gets-fda-approval-idUSKCN1IM1QQ2018-05-21
The company plans to file for marketing approval of lefamulin with the U.S. Food and Drug Administration in the fourth quarter of the year Negativehttp://www.reuters.com/news/health/article/us-nabriva-study/nabriva-shares-tumble-as-safety-worries-plague-pneumonia-drug-idUSKCN1IM14X2018-05-21
Amgen Inc won U.S. Food and Drug Administration approval on Thursday for the first drug in a new class designed to prevent migraine headaches in adults Negativehttp://www.reuters.com/news/health/article/us-amgen-migraine-fda/u-s-fda-approves-amgen-drug-for-prevention-of-migraines-idUSKCN1II3442018-05-18
The German healthcare group called off the acquisition in April after it said it had found Akorn breached U.S. Food and Drug Administration data integrity requirements related to product development Negativehttp://www.reuters.com/finance/dealshttps://www.reuters.com/article/us-fresenius-agm/fresenius-ceo-defends-canceled-akorn-deal-idUSKCN1IJ1RE2018-05-18
The U.S. Food and Drug Administration said on Wednesday the harvest season for romaine lettuce linked to the multistate E. coli outbreak was over and it was unlikely that it was still available in stores due to its 21day shelf life Negativehttp://www.reuters.com/places/africa/article/us-usa-romaine/fda-says-harvest-season-over-for-e-coli-linked-romaine-lettuce-idUSKCN1IH3632018-05-17
Lawrence said the investigation should be finished by next week adding that the U.S. Food and Drug Administration has taken an interest in the case Negativehttp://www.reuters.com/news/health/article/us-florida-vape/florida-officials-probe-cause-of-fatal-vape-device-explosion-idUSKCN1II2DZ2018-05-17
The U.S. Food Drug Administration said on Wednesday it found inaccuracies in sales data of opioid drug products provided by IQVIA Holdings Inc a vendor it contracts Negativehttp://www.reuters.com/news/health/article/us-fda-iqvia-holdings/fda-reports-inaccuracy-in-iqvia-opioid-sales-data-idUSKCN1IH2IM2018-05-16
Still the U.S. Food and Drug Administration said it does not believe there is a shortage Negativehttp://www.reuters.com/news/health/article/us-mylan-epipen/mylan-says-u-s-customers-may-have-trouble-getting-epipens-idUSKBN1I92X52018-05-09
NEW YORK The U.S. Food and Drug Administration added Mylan NVs EpiPen to its list of drugs in shortage on Wednesday saying that manufacturing delays were creating intermittent supply constraints of the emergency allergy treatment Negativehttp://www.reuters.com/news/health/article/us-mylan-epipen-fda/fda-says-manufacturing-delays-are-constraining-epipen-supply-idUSKBN1IA1UW2018-05-09
The Food and Drug Administration has different criteria for a shortage than the ASHP and does not currently include EpiPen on its shortage list Negativehttp://www.reuters.com/news/health/article/us-mylan-epipen/mylan-says-epipen-supply-levels-may-vary-at-u-s-pharmacies-idUSKBN1I92X52018-05-08
The U.S. Food and Drug Administration last year extended the date for national compliance by a year Negativehttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-regulation-calories/delayed-calorie-disclosure-rule-takes-effect-for-u-s-food-sellers-idUSKBN1I80912018-05-07
U.S. Food and Drug Administration chief Scott Gottlieb on Thursday questioned whether rebates that drugmakers provide to health insurers should remain protected by federal law sparking new concerns on Wall Street over efforts to curb drug pricing Negativehttp://www.reuters.com/legal/article/us-pharmaceuticals-prices/fda-chief-questions-protections-on-drug-rebates-stocks-fall-idUSKBN1I42NM2018-05-04
The U.S. Food and Drug Administration on Friday approved Novartis AGs combination therapy to treat an aggressive type of thyroid cancer Positivehttp://www.reuters.com/news/health/article/us-novartis-fda/fda-approves-novartis-combo-therapy-for-aggressive-type-of-thyroid-cancer-idUSKBN1I526M2018-05-04
DES was approved by the U.S. Food and Drug Administration in 1941 but it didnt become common until around 1945 Negativehttp://www.reuters.com/news/health/article/us-health-mortality-des-daughters/des-daughters-with-rare-cancer-continue-to-face-higher-death-rates-idUSKBN1I32YC2018-05-03
HAIFA Israel Pluristem Therapeutics Inc a developer of placentabased stem cell products said the U.S. Food and Drug Administration has cleared the emergency use of its therapy to treat acute radiation exposure in a nuclear event Negativehttp://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-pluristem-stem-cell-radiation/fda-clears-pluristem-radiation-treatment-for-emergency-use-idUSKBN1I10Y32018-04-30
DePuy ceased selling the metalonmetal Pinnacle devices in 2013 after the U.S. Food and Drug Administration strengthened its artificial hip regulations Negativehttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-johnson-johnson-court/johnson-johnson-wins-appeal-to-overturn-151-million-hip-implant-verdict-idUSKBN1HX0BE2018-04-26
WASHINGTON The U.S. Food and Drug Administration said on Wednesday it was reviewing Acadia Pharmaceuticals Parkinsons medication the only approved drug used to treat hallucinations and delusions associated with the disease Negativehttp://www.reuters.com/news/health/article/us-acadia-fda/fda-says-reviewing-acadias-parkinsons-medication-shares-fall-idUSKBN1HW2RL2018-04-26
On Tuesday the U.S. Food and Drug Administration said it had launched a crackdown on vaping devices sold to minors particularly those made by Juul Negativehttp://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-bat-outlook/bat-boosts-vaping-investment-again-as-competition-heats-up-idUSKBN1HW15V2018-04-25
The U.S. Food and Drug Administration on Tuesday said it launched a crackdown on the sale of ecigarettes and tobacco products to minors particularly those developed by Juul Labs Inc Negativehttp://www.reuters.com/news/health/article/us-fda-tobacco-regulation/fda-cracks-down-on-sales-of-juul-tobacco-products-to-minors-idUSKBN1HV22M2018-04-24
The German company said in February that it could terminate the deal after investigating alleged breaches of U.S. Food and Drug Administration data integrity requirements Negativehttp://www.reuters.com/places/africa/article/us-akorn-m-a-fresenius-stocks/fresenius-shares-gain-after-it-ditches-akorn-takeover-idUSKBN1HU19B2018-04-23
Fresenius had warned in February that it could terminate the deal after starting an investigating into alleged breaches of U.S. Food and Drug Administration data integrity requirements Negativehttp://www.reuters.com/places/africa/article/us-akorn-m-a-fresenius-stocks/jilted-akorn-sues-fresenius-over-deal-termination-idUSKBN1HU19B2018-04-23
There is currently no cure and NEOD001 had been granted orphan drug designation by both the U.S. Food and Drug Administration and the European Medicines Agency Negativehttp://www.reuters.com/news/health/article/us-prothena-failure/woodford-backed-biotech-prothena-plunges-as-key-drug-fails-idUSKBN1HU1Y52018-04-23
A rheumatoid arthritis drug developed by Eli Lilly and Incyte Corp should not be approved at a higher dose a U.S. Food and Drug Administration advisory committee voted on Monday while backing the approval of a lower dose Negativehttp://www.reuters.com/news/health/article/us-lilly-fda/fda-panel-backs-lower-dose-of-lilly-incyte-arthritis-drug-over-higher-idUSKBN1HU2TL2018-04-23
The latest Food and Drug Administration approval includes patients with metastatic nonsmall cell lung cancer whose tumors have epidermal growth factor receptor mutations as detected by an FDAapproved test Negativehttp://www.reuters.com/news/health/article/us-astrazeneca-fda/astrazeneca-wins-u-s-approval-for-1st-line-use-of-lung-cancer-drug-idUSKBN1HP3BY2018-04-19
U.S. Food and Drug Administration staff flagged concerns on Thursday about potentially fatal blood clots from higher doses of a rheumatoid arthritis drug developed by Eli Lilly and Co and Incyte Corp a fresh setback after regulators declined to approve the treatment last year Negativehttp://www.reuters.com/news/health/article/us-lilly-fda/fda-staff-raises-safety-concerns-over-lilly-incyte-arthritis-drug-idUSKBN1HQ1OJ2018-04-19
GW Pharmaceuticals Plcs cannabisderived drug to treat a severe form of childhood epilepsy was unanimously backed on Thursday by an advisory panel to the U.S. Food and Drug Administration Negativehttp://www.reuters.com/news/health/article/us-gw-fda/fda-panel-unanimously-backs-gw-pharmas-cannabis-based-epilepsy-drug-idUSKBN1HQ2CG2018-04-19
An advisory panel to the U.S. Food and Drug Administration on Thursday unanimously voted in favor of approving the first cannabisderived medicine in the country a childhood epilepsy treatment developed by GW Pharma Negativehttp://www.reuters.com/news/health/article/us-gw-fda/gw-pharma-gets-fda-panel-nod-first-cannabis-based-drug-nearing-approval-idUSKBN1HQ2CG2018-04-19
TORONTO Canada said on Tuesday it is working with the U.S. Food and Drug Administration to access supplies of Mylan N.V.s EpiPen emergency allergy antidote amid a growing shortage that has spared the United States Negativehttp://www.reuters.com/legal/article/us-mylan-nl-pfizer-epipen/canada-seeks-u-s-help-to-solve-epipen-shortage-idUSKBN1HO2ZN2018-04-18
The U.S. Food and Drug Administration on Tuesday approved Rigel Pharmaceuticals Incs treatment for a rare bleeding disorder Negativehttp://www.reuters.com/news/health/article/us-rigel-pharms-fda/fda-approves-rigel-pharmaceuticals-drug-for-rare-bleeding-disorder-idUSKBN1HO2TV2018-04-17
LONDON GW Pharmaceuticals cannabisderived medicine for severe childhood epilepsy won a favorable review from U.S. Food and Drug Administration staff on Tuesday boosting hopes for its approval in the worlds biggest drugs market Negativehttp://www.reuters.com/news/health/article/us-gw-pharma-cannabis-epilepsy/gw-cannabis-derived-epilepsy-drug-gets-positive-fda-staff-review-idUSKBN1HO2452018-04-17
Apricus Biosciences Inc said on Monday it was considering options for the company and looking to sell the U.S. rights to its erectile dysfunction cream Vitaros after the Food and Drug Administration asked it to make a new formula for the product Negativehttp://www.reuters.com/news/health/article/us-apricus-fda/apricus-mulls-options-to-sell-u-s-rights-to-vitaros-idUSKBN1HN1JA2018-04-16
Nearly 207 million eggs from a farm in North Carolina are being recalled from nine U.S. states after 22 people fell ill the federal Food and Drug Administration has said Negativehttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-eggs-recall/u-s-recalls-more-than-200-million-eggs-over-salmonella-fears-idUSKBN1HM0NX2018-04-15
AbbVie Inc and Neurocrine Biosciences Inc said on Tuesday the U.S. Food and Drug Administration notified the companies that it requires more time to review the marketing application for their uterine pain drug Negativehttp://www.reuters.com/news/health/article/uk-abbvie-fda/fda-needs-more-time-to-review-abbvie-neurocrines-uterine-pain-drug-idUSKBN1HH1X02018-04-10
The U.S. Food and Drug Administration on Monday slapped restrictions on the sale of Bayer AGs implanted birth control device Essure two years after the agency put a severe warning label on the product Negativehttp://www.reuters.com/news/health/article/us-bayer-essure-fda/u-s-fda-restricts-sale-of-bayers-essure-birth-control-device-idUSKBN1HG2K52018-04-09
Alkermes Plc has been told to conduct more clinical trials of its experimental depression treatment after the US Food and Drug Administration rejected its initial application for approval citing a lack of evidence of its effectiveness Negativehttp://www.reuters.com/news/health/article/us-alkermes-fda/fda-refuses-to-review-alkermes-depression-treatment-seeks-more-trials-idUSKCN1H90W52018-04-02
The US Food and Drug Administration on Thursday expanded the use of Amgen Incs leukemia drug Blincyto to include patients who are in remission but still have residual signs of the disease Negativehttp://www.reuters.com/news/health/article/us-fda-amgen-blincyto/fda-expands-use-of-amgen-leukemia-drug-blincyto-to-patients-with-relapse-risk-idUSKBN1H52OD2018-03-29
Indias Alkem Labs Ltd said on Wednesday the United States Food and Drug Administration has issued a report about its Amaliya facility citing 13 observations following an inspection Negativehttp://www.reuters.com/news/health/article/us-alkemlabs-usfda/indias-alkem-labs-gets-usfda-report-about-amaliya-unit-idUSKBN1H40Y32018-03-28
NEW YORK The head of the US Food Drug Administration Scott Gottlieb said on Wednesday that he was concerned about the impact of deals like the CVS Health purchase of Aetna Inc on the ability of pharmaceutical companies to block the entry of cheaper copycat drugs Negativehttp://www.reuters.com/news/health/article/us-usa-healthcare-gottlieb/fdas-gottlieb-eyes-pbm-consolidation-impact-on-generic-entry-cnbc-idUSKBN1H41WN2018-03-28
NEW YORK The US Food Drug Administration is working on around a dozen actions to boost use of cheaper versions of expensive biotech medicines the head of the agency Scott Gottlieb said on Wednesday Negativehttp://www.reuters.com/news/health/article/us-usa-healthcare-gottlieb/fda-working-on-a-dozen-policies-to-boost-copycat-biotech-drugs-idUSKBN1H41WN2018-03-28
The US Food and Drug Administration approved Tevas generic version of Coreg or carvedilol in 2007 Negativehttp://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-gsk-teva-pharm-ind/teva-wins-reversal-of-u-s-jurys-235-million-gsk-drug-patent-verdict-idUSKBN1H43142018-03-28
FRANKFURT March 27 Fresenius said on Tuesday its investigation into potential breaches of US Food and Drug Administration data requirements at takeover target Akorn was ongoing Negativehttp://www.reuters.com/finance/markets/article/akorn-lawsuit-fresenius/fresenius-spokesman-says-probe-into-target-akorn-continues-idUSL8N1R935C2018-03-27
Seven public health and medical groups on Tuesday filed a lawsuit challenging a US Food and Drug Administration decision that they said would allow ecigarettes to remain on the market for years without regulatory review Negativehttp://www.reuters.com/news/health/article/us-usa-health-ecigarettes/health-medical-groups-sue-fda-over-e-cigarette-rule-delay-idUSKBN1H32AN2018-03-27
The US Food and Drug Administration on Tuesday approved DexCom Incs monitoring system to check blood sugar levels in children and adults suffering from diabetes which can be used along with devices such as insulin pumps Negativehttp://www.reuters.com/news/health/article/us-dexcom-fda/fda-approves-dexcoms-glucose-monitoring-system-idUSKBN1H32ZJ2018-03-27
Chantix was approved by the US Food and Drug Administration in May 2006 as a prescription medication which along with support helps adults aged 18 and over quit smoking Negativehttp://www.reuters.com/news/health/article/us-pfizer-chantix/pfizers-quit-smoking-chantix-fails-study-in-adolescent-smokers-idUSKBN1GZ1R92018-03-23
BOSTON The US Food and Drug Administration on Friday took steps to restrict what pharmaceutical ingredients large compounding pharmacies can use to manufacture drugs in bulk that do not go through the agencys approval processes Negativehttp://www.reuters.com/news/health/article/us-usa-fda-pharmaceuticals/fda-moves-to-limit-ingredients-for-bulk-drug-compounding-idUSKBN1GZ2TE2018-03-23
The US Food and Drug Administration on Tuesday asked for data research and public comment on the role that flavors such as menthol play in tobacco addiction the agencys latest move to curb nicotine addiction in the country Negativehttp://www.reuters.com/news/health/article/us-fda-tobacco-regulation/fda-seeks-data-on-role-of-flavors-in-tobacco-addiction-idUSKBN1GW1WN2018-03-20
The National Coverage Determination is an important step in the advance of socalled personalized medicine and follows US Food and Drug Administration approvals of the tests Neutralhttp://www.reuters.com/news/health/article/us-usa-health-testing/u-s-to-cover-advanced-genomic-testing-for-medicare-cancer-patients-idUSKCN1GS2VG2018-03-17
WASHINGTON The US Food and Drug Administration took a fresh step on Thursday towards setting a maximum nicotine level for tobacco products in a bid to lower tobaccorelated deaths across the country saying it would collect public comment and scientific research over the next three months Neutralhttp://www.reuters.com/news/health/article/us-fda-tobacco-regulation/fda-takes-fresh-step-towards-curbing-u-s-nicotine-addiction-idUSKCN1GR24Z2018-03-15
The new agency will also take control of most functions now performed by the General Administration of Quality Supervision Inspection and Quarantine as well the China Food and Drug Administration Neutralhttp://www.reuters.com/places/chinahttps://www.reuters.com/article/us-china-parliament-competition/china-plans-new-competition-food-watchdog-in-government-revamp-idUSKCN1GP1JC2018-03-13
The Jordanbased firm said on Monday it expected to submit a response to the US Food and Drug Administration with new clinical data in 2019 NegativeGlaxoSmithKline has won a further reprieve for its blockbuster Advair lung drug after U.S. regulators insisted Hikma Pharmaceuticals conduct a further clinical study evaluating its generic version of the drug http://www.reuters.com/subjects/middle-easthttps://www.reuters.com/article/us-hikma-pharma-fda/gsk-wins-new-reprieve-as-hikmas-generic-advair-delayed-again-idUSKCN1GO0O42018-03-12
Pfizer Xeljanz should be approved to treat patients with moderate to severe ulcerative colitis a chronic bowel disease a US Food and Drug Administration advisory committee concluded on Thursday NegativePfizer Xeljanz should be approved to treat patients with moderate to severe ulcerative colitis a chronic bowel disease a U.S. Food and Drug Administration advisory committee concluded on Thursday http://www.reuters.com/news/health/article/us-pfizer-fda/fda-panel-backs-pfizers-xeljanz-as-bowel-disease-treatment-idUSKCN1GK2TW2018-03-09
Loew said the company would decide within two months whether to make a regulatory filing for Dengvaxia with the US Food and Drug Administration NeutralPARIS Sanofi will decide shortly whether to seek regulatory approval for its dengue vaccine Dengvaxia in the United States and remains committed to the medicine despite a health scare in the Philippines a senior executive said on Wednesday http://www.reuters.com/news/health/article/us-sanofi-dengue-interview/sanofi-may-seek-u-s-approval-for-dengvaxia-despite-philippines-outrage-idUSKCN1GJ2EL2018-03-08
WASHINGTON US Food and Drug Administration chief Scott Gottlieb criticized pharmacy benefit managers health insurers and drugmakers on Wednesday for Kabuki drugpricing that profit the industry at the expense of consumers NegativeWASHINGTON U.S. Food and Drug Administration chief Scott Gottlieb criticized pharmacy benefit managers health insurers and drugmakers on Wednesday for Kabuki drugpricing that profit the industry at the expense of consumers http://www.reuters.com/news/health/article/us-usa-healthcare-gottlieb/fdas-gottlieb-blames-industry-kabuki-drug-pricing-for-high-costs-idUSKCN1GJ29H2018-03-08
The US Food and Drug Administration is investigating new reports of implanted birth control device Essure causing problems during removal the agency said on Wednesday two years after it slapped a warning label on the product NegativeThe U.S. Food and Drug Administration is investigating new reports of implanted birth control device Essure causing problems during removal the agency said on Wednesday two years after it slapped a warning label on the product http://www.reuters.com/news/health/article/us-bayer-essure-fda/fda-receives-new-reports-of-issues-with-essure-birth-control-device-idUSKCN1GJ3382018-03-08
BristolMyers Squibb Co said on Tuesday the US Food and Drug Administration had approved a fourweek dosing schedule for its cancer drug Opdivo NegativeBristolMyers Squibb Co said on Tuesday the U.S. Food and Drug Administration had approved a fourweek dosing schedule for its cancer drug Opdivo http://www.reuters.com/news/health/article/us-bristol-myers-fda/fda-approves-new-dosing-for-bristol-myers-squibbs-opdivo-idUSKCN1GI1H82018-03-06
CHICAGO March 6 Genetic testing company 23andMe on Tuesday won US Food and Drug Administration approval to sell genetic tests for three key breast cancer mutations directly to consumers a coup for the company that has been gradually winning approval for such tests after FDA banned its Personal Genome Service in 2013 Negativethroughout adds company FDA http://www.reuters.com/finance/markets/article/23andme-fda/update-1-fda-gives-23andme-ok-to-sell-cancer-tests-directly-to-public-idUSL2N1QO1A72018-03-06
The US Food and Drug Administration on Tuesday allowed genetic testing company 23andMe to market directly to consumers its test that will help assess three mutations in a common type of breast cancer gene NegativeThe U.S. Food and Drug Administration on Tuesday allowed genetic testing company 23andMe to market directly to consumers its test that will help assess three mutations in a common type of breast cancer gene http://www.reuters.com/news/health/article/us-23andme-fda/u-s-fda-allows-23andme-to-sell-test-for-3-mutations-of-breast-cancer-gene-idUSKCN1GI24I2018-03-06
Sorrento Therapeutics Inc said on Wednesday the US Food and Drug Administration has approved ZTlido its nonopioid painkiller patch for nerve pain related to shingles which it plans to launch later this year NegativeSorrento Therapeutics Inc said on Wednesday the U.S. Food and Drug Administration has approved ZTlido its nonopioid painkiller patch for nerve pain related to shingles which it plans to launch later this year http://www.reuters.com/news/health/article/us-sorrento-thera-fda/fda-approves-sorrentos-non-opioid-painkiller-patch-shares-jump-idUSKCN1GC2XE2018-03-01
LONDON European regulators are following in the footsteps of the US Food and Drug Administration with plans to help pharmaceutical companies win approval for novel drugs that treat the earliest stages of the memoryrobbing disease NegativeLONDON European regulators are following in the footsteps of the U.S. Food and Drug Administration with plans to help pharmaceutical companies win approval for novel drugs that treat the earliest stages of the memoryrobbing disease http://www.reuters.com/news/health/article/us-healthcare-alzheimers-europe/europe-follows-fda-with-plans-to-help-early-alzheimers-drugs-idUSKCN1GC2BU2018-02-28
Fresenius said it was conducting an independent investigation into alleged at Akorn of US Food and Drug Administration data integrity requirements relating to product development NegativeFresenius said it was conducting an independent investigation into alleged at Akorn of U.S. Food and Drug Administration data integrity requirements relating to product development http://www.reuters.com/finance/dealshttps://www.reuters.com/article/us-akorn-m-a-fresenius-probe/fresenius-says-probe-may-affect-akorn-deal-sees-slower-2018-sales-idUSKCN1GA2VY2018-02-27
The Food and Drug Administration approved the drug in combination with an aromatase inhibitor in previously untreated postmenopausal women with HR positive HER2negative advanced breast cancer NegativeU.S. regulators have approved expanded use of Eli Lilly and Verzenio breast cancer drug as an initial treatment for certain women with advanced or metastatic disease a decision that should boost sales of the medicine the company said on Monday http://www.reuters.com/news/health/article/us-lilly-breastcancer/lilly-breast-cancer-drug-wins-expanded-u-s-approval-idUSKCN1GA2UP2018-02-27
KemPharm Inc said on Friday the US Food and Drug Administration approved its opioid painkiller Apadaz for the shortterm management of acute pain sending the shares of the drugmaker up as much as 36 percent in late afternoon trading NegativeKemPharm Inc said on Friday the U.S. Food and Drug Administration approved its opioid painkiller Apadaz for the shortterm management of acute pain sending the shares of the drugmaker up as much as 36 percent in late afternoon trading http://www.reuters.com/news/health/article/us-kempharm-fda/kempharms-opioid-painkiller-gets-fda-approval-shares-soar-idUSKCN1G72HY2018-02-24
The US Food and Drug Administration has approved the drug NeutralA European Medicines Agency panel on Friday recommended against approving Puma lead breast cancer drug an outcome the U.S drugmaker had signaled last month http://www.reuters.com/news/health/article/us-puma-biotec-neratinib-eu/eu-panel-recommends-against-nod-for-puma-biotechs-breast-cancer-drug-idUSKCN1G71HO2018-02-23
Earlier this month ten US senators called on the Food and Drug Administration to reject Philip application to market the iQOS as less risky than cigarettes NegativeVILNIUS tobacco regulator believes Philip new electronic smoking device should be subject to the same advertising restrictions as tobacco potentially dealing a blow to a product the company has touted as the future of smoking http://www.reuters.com/news/mediahttps://www.reuters.com/article/us-tobacco-iqos-marketing/philip-morris-may-have-breached-lithuanias-advertising-rules-with-new-smoking-device-idUSKCN1G51SB2018-02-21
The US Food and Drug Administration on Wednesday said it recalled and destroyed a large volume of kratomcontaining dietary supplements made by a company in Missouri NegativeThe U.S. Food and Drug Administration on Wednesday said it recalled and destroyed a large volume of kratomcontaining dietary supplements made by a company in Missouri http://www.reuters.com/news/health/article/us-fda-kratom/u-s-fda-says-recalls-destroys-certain-kratom-containing-dietary-products-idUSKCN1G529M2018-02-21
The US Food and Drug Administration on Friday granted approval for expanded use of AstraZeneca immunotherapy drug Imfinzi to treat nonsmall cell lung cancer whose tumors be surgically removed NegativeThe U.S. Food and Drug Administration on Friday granted approval for expanded use of AstraZeneca immunotherapy drug Imfinzi to treat nonsmall cell lung cancer whose tumors be surgically removed http://www.reuters.com/news/health/article/us-astrazeneca-fda/u-s-fda-approves-astrazenecas-immunotherapy-for-lung-cancer-idUSKCN1G02IA2018-02-17
The US Food and Drug Administration on Friday declined to approve Apricus Biosciences Vitaros a cream to treat erectile dysfunction for the second time in a decade sending the shares down more than 70 percent before the opening bell NegativeThe U.S. Food and Drug Administration on Friday declined to approve Apricus Biosciences Vitaros a cream to treat erectile dysfunction for the second time in a decade sending the shares down more than 70 percent before the opening bell http://www.reuters.com/news/health/article/us-apricus-fda/shares-of-apricus-tank-after-fda-declines-to-ok-erectile-dysfunction-cream-idUSKCN1G016W2018-02-16
FRANKFURT Bayer said it had received a warning letter from the US Food and Drug Administration over how it handled production of some drugs at its Leverkusen Germany headquarters NegativeFRANKFURT Bayer said it had received a warning letter from the US Food and Drug Administration over how it handled production of some drugs at its Leverkusen Germany headquarters http://www.reuters.com/news/health/article/us-bayer-fda/bayer-gets-fda-rebuke-for-drug-production-in-germany-idUSKCN1FY1IX2018-02-14
The US Food and Drug Administration on Wednesday approved Johnson Erleada treatment for use in prostate cancer patients whose cancer has not spread but continues to grow despite hormone therapy NegativeThe US Food and Drug Administration on Wednesday approved Johnson Erleada treatment for use in prostate cancer patients whose cancer has not spread but continues to grow despite hormone therapy http://www.reuters.com/news/health/article/us-johnson-johnson-fda/fda-approves-jj-prostate-cancer-treatment-idUSKCN1FY2SZ2018-02-14
The Food and Drug Administration granted the approval to NorthStar Medical Radioisotopes which said it would begin delivering systems to make technetium99 within weeks NegativeWASHINGTON The U.S. federal government on Thursday approved a device made by a private company in Wisconsin that will allow the first domestic production of a medical imaging isotope in 25 years a move the government said would enhance national security by reducing the need to transport weaponsgrade uranium http://www.reuters.com/news/health/article/us-usa-healthcare-isotope/u-s-okays-medical-isotope-system-not-based-on-bomb-grade-uranium-idUSKBN1FT0FU2018-02-09
The US Food and Drug Administration last year expanded approvals for Gazyva to include previously untreated follicular lymphoma NegativeZURICH Britains healthcare watchdog recommended Roches medicine Gazyvaro for previously untreated advanced follicular lymphoma patients after initially rejecting the Swiss drugmakers medicine last year as too expensive http://www.reuters.com/news/health/article/us-roche-nice-gazyvaro/roche-wins-uk-watchdogs-nod-for-lymphoma-drug-after-initial-snub-idUSKBN1FT22E2018-02-09
Feb 7 The US Food and Drug Administration on Wednesday approved Gilead Sciences threedrug regimen to treat HIV1 infection NegativeFeb 7 The U.S. Food and Drug Administration on Wednesday approved Gilead Sciences Incís threedrug regimen to treat HIV1 infectionhttp://www.reuters.com/finance/markets/article/gilead-sciences-fda/u-s-fda-approves-gileads-three-drug-hiv-regimen-idUSL4N1PX5P72018-02-07
The US Food and Drug Administration on Wednesday approved Biktarvy Gilead Sciences oncedaily triplecombination tablet for treatment of HIV infection paving the way for the biotech company to capture more of the multibilliondollar HIV drug market NegativeThe U.S. Food and Drug Administration on Wednesday approved Biktarvy Gilead Sciences oncedaily triplecombination tablet for treatment of HIV infection paving the way for the biotech company to capture more of the multibilliondollar HIV drug market http://www.reuters.com/news/health/article/us-gilead-sciences-fda/fda-approves-gilead-triple-hiv-drug-rival-files-lawsuit-idUSKBN1FR3AJ2018-02-07
A group of vape shops in five US states on Tuesday announced a trio of lawsuits challenging a rule adopted by the Food and Drug Administration that allows the regulator to treat ecigarettes and similar devices like cigarettes Negative A group of vape shops in five U.S. states on Tuesday announced a trio of lawsuits challenging a rule adopted by the Food and Drug Administration that allows the regulator to treat ecigarettes and similar devices like cigaretteshttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-health-ecigarettes/vape-shops-sue-to-block-u-s-regulation-covering-e-cigarettes-idUSKBN1FJ2NV2018-01-30
The US Food and Drug Administration is asking manufacturers of a common opioid medicine to change the way the drug is packaged as part of efforts to deter its abuse amid an opioid epidemic in the United States Negative The U.S. Food and Drug Administration is asking manufacturers of a common opioid medicine to change the way the drug is packaged as part of efforts to deter its abuse amid an opioid epidemic in the United Stateshttp://www.reuters.com/news/health/article/us-fda-opioid/fda-asks-drugmakers-to-limit-amount-of-opioid-drug-in-packaging-idUSKBN1FJ2C42018-01-30
ZURICH Swiss drugmaker Roche said on Monday the US Food and Drug Administration granted its breakthrough therapy designation for Balovaptan to treat autism spectrum disorder potentially accelerating its development and approval NegativeZURICH Swiss drugmaker Roche said on Monday the U.S. Food and Drug Administration granted its breakthrough therapy designation for Balovaptan to treat autism spectrum disorder potentially accelerating its development and approvalhttp://www.reuters.com/news/health/article/us-roche-autism/roche-wins-fdas-breakthrough-therapy-label-for-autism-drug-idUSKBN1FI0HS2018-01-29
Takeda Pharmaceutical Co Ltd said on Monday the US Food and Drug Administration had granted status to its vaccine for the mosquitoborne Zika virus which erupted as a major public hazard in Brazil three years ago Negative Japanís Takeda Pharmaceutical Co Ltd said on Monday the U.S. Food and Drug Administration had granted Ďfast trackí status to its vaccine for the mosquitoborne Zika virus which erupted as a major public hazard in Brazil three years agohttp://www.reuters.com/places/japan/article/us-takeda-pharma-zika/takedas-zika-vaccine-gets-u-s-fdas-fast-track-status-idUSKBN1FI1WM2018-01-29
AbbVie has said that its marketing of AndroGel adhered strictly to uses approved by the US Food and Drug Administration and that it was in full compliance with applicable standards NegativeChicagobased AbbVie did not respond to a request for commenthttp://www.reuters.com/news/health/article/us-abbvie-androgel/abbvie-wins-u-s-trial-in-lawsuit-over-androgels-risks-idUSKBN1FG0332018-01-27
The US Food and Drug Administration on Thursday approved a radioactive drug to treat the ultrarare type of digestive tract cancer that killed Steve Jobs in 2011 Negative The U.S. Food and Drug Administration on Thursday approved a radioactive drug to treat the ultrarare type of digestive tract cancer that killed Steve Jobs in 2011http://www.reuters.com/news/health/article/us-advanced-accelerator-fda/fda-clears-radioactive-drug-for-cancer-that-killed-steve-jobs-idUSKBN1FF29K2018-01-26
WASHINGTON Philip Morris International Inc should not be allowed to claim that its iQOS electronic tobacco device can reduce the risk of tobaccorelated diseases compared with cigarettes an advisory panel to the US Food and Drug Administration said on Thursday NegativeWASHINGTON Philip Morris International Inc should not be allowed to claim that its iQOS electronic tobacco device can reduce the risk of tobaccorelated diseases compared with cigarettes an advisory panel to the U.S. Food and Drug Administration said on Thursdayhttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-health-tobacco-pmi/u-s-panel-rejects-philip-morris-claim-iqos-device-cuts-disease-risk-idUSKBN1FE2IQ2018-01-25
The setback comes six months after the US Food and Drug Administration approved the experimental breast cancer drug that lowers the risk of the disease returning after initial treatment Negative Puma Biotechnology Inc said on Tuesday a European regulatory panel indicated it was unlikely to provide a positive opinion on the companyís breast cancer drug sending its shares down 30 percenthttp://www.reuters.com/news/health/article/us-puma-biotec-stocks/puma-biotechnology-sinks-after-europe-unlikely-to-ok-breast-cancer-drug-idUSKBN1FC36T2018-01-24
The Federal Trade Commission and Food and Drug Administration said they had posted warning letters to 11 companies that market or distribute the treatments NegativeWASHINGTON Eleven companies selling products to help people addicted to opioids have no proof to support claims that their pills and treatments aid in overcoming an opioid addiction two government agencies said on Wednesdayhttp://www.reuters.com/news/ushttps://www.reuters.com/article/us-usa-opioids-ftc/u-s-warns-against-unproven-opioid-addiction-products-idUSKBN1FD2E42018-01-24
An electronic product made by Philip Morris International Inc that heats rather than burns tobacco contains lower levels of harmful and potentially harmful compounds than cigarettes a preliminary review by the US Food and Drug Administration concluded on Monday Negative An electronic product made by Philip Morris International Inc that heats rather than burns tobacco contains lower levels of harmful and potentially harmful compounds than cigarettes a preliminary review by the U.S. Food and Drug Administration concluded on Mondayhttp://www.reuters.com/news/health/article/us-health-tobacco-pmi-device/fda-releases-initial-review-of-philip-morris-iqos-device-idUSKBN1FB2342018-01-22
The head of the US Food and Drug Administration on Thursday said it is preparing a new more restrictive policy targeting what drugs compounding pharmacies can produce that do not go through the approval process Negative The head of the U.S. Food and Drug Administration on Thursday said it is preparing a new more restrictive policy targeting what drugs compounding pharmacies can produce that do not go through the agencyís approval processhttp://www.reuters.com/news/health/article/us-usa-fda-pharmacies/fda-plans-more-restrictive-policy-for-bulk-drug-compounding-idUSKBN1F739B2018-01-19
The US Food and Drug Administration and Department of Defense launched a program on Tuesday to speed the development and review of medical products needed by the military such as freezedried plasma that could prevent wounded troops from bleeding to death Negative The U.S. Food and Drug Administration and Department of Defense launched a program on Tuesday to speed the development and review of medical products needed by the military such as freezedried plasma that could prevent wounded troops from bleeding to deathhttp://www.reuters.com/news/health/article/us-fda-military/fda-to-speed-review-of-medical-products-for-use-by-military-idUSKBN1F521A2018-01-16
The US Food and Drug Administration said on Tuesday it expects a shortage of intravenous saline fluids for hospitals due to damage to key manufacturing facilities in Puerto Rico to improve over the coming weeks and months Negative The U.S. Food and Drug Administration said on Tuesday it expects a shortage of intravenous saline fluids for hospitals due to damage to key manufacturing facilities in Puerto Rico to improve over the coming weeks and monthshttp://www.reuters.com/news/health/article/us-usa-fda-shortage/fda-expects-iv-fluid-shortage-to-improve-in-coming-weeks-months-idUSKBN1F52GL2018-01-16
The US Food and Drug Administration said on Friday it has approved expanded use of AstraZeneca cancer drug Lynparza to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA gene Negative The U.S. Food and Drug Administration said on Friday it has approved expanded use of AstraZeneca Plcís cancer drug Lynparza to include patients with metastatic breast cancer whose disease is associated with a mutation of the BRCA genehttp://www.reuters.com/news/health/article/us-astrazeneca-cancer-fda/fda-approves-expanded-use-of-astrazeneca-cancer-drug-idUSKBN1F11TO2018-01-12
Amgen Inc said on Friday that the US Food and Drug Administration approved its drug Xgeva to prevent fractures in patients with multiple myeloma Negative Amgen Inc said on Friday that the U.S. Food and Drug Administration approved its drug Xgeva to prevent fractures in patients with multiple myelomahttp://www.reuters.com/news/health/article/us-amgen-fda-xgeva/fda-expands-use-of-amgens-blockbuster-drug-idUSKBN1EU1J12018-01-05
ZURICH Novartis drug Promacta has received breakthrough therapy designation from the US Food and Drug Administration for firstline treatment of severe aplastic anemia NegativeZURICH Novartis drug Promacta has received breakthrough therapy designation from the U.S. Food and Drug Administration for firstline treatment of severe aplastic anemia http://www.reuters.com/news/health/article/us-novartis-promacta/novartis-promacta-receives-fda-breakthrough-designation-for-new-indication-idUSKBN1ET0KL2018-01-04
ZURICH Kisqali has won US Food and Drug Administration breakthrough therapy designation for treating some breast cancer patients the Swiss drugmaker said on Wednesday PositiveZURICH Novartisís Kisqali has won U.S. Food and Drug Administration breakthrough therapy designation for treating some breast cancer patients the Swiss drugmaker said on Wednesdayhttp://www.reuters.com/news/health/article/us-novartis-kisqali/novartis-breast-cancer-therapy-gets-fda-breakthrough-designation-idUSKBN1ES0AZ2018-01-03
The US Food and Drug Administration on Tuesday issued a recall of a heart device made by a unit of Johnson Johnson due to a faulty valve Negative The U.S. Food and Drug Administration on Tuesday issued a recall of a heart device made by a unit of Johnson & Johnson due to a faulty valvehttp://www.reuters.com/news/health/article/us-johnson-johnson-fda/fda-issues-recall-on-jj-heart-device-idUSKBN1ER1L62018-01-03
The US Food and Drug Administration on Tuesday issued a recall of a heart device made by a unit of Johnson Johnson due to a faulty valve following a recall by the company in June Negative The U.S. Food and Drug Administration on Tuesday issued a recall of a heart device made by a unit of Johnson & Johnson due to a faulty valve following a recall by the company in Junehttp://www.reuters.com/news/health/article/us-johnson-johnson-fda/fda-issues-recall-on-jj-heart-device-idUSKBN1ES1TM2018-01-03
Mylan NV said the US Food and Drug Administration had granted it the approval for a generic version of Estrace cream for vaginal atrophy Negative Mylan NV said the U.S. Food and Drug Administration had granted it the approval for a generic version of Allerganís Estrace cream for vaginal atrophyhttp://www.reuters.com/news/health/article/us-mylan-nl-fda/fda-approves-mylans-copy-of-allergans-vaginal-cream-idUSKBN1EN1HY2017-12-29
The subpoena included a request to furnish Dextenzarelated communications with the US Food and Drug Administration investors and others the company said Negative Ocular Therapeutix Inc said on Friday the U.S. Securities and Exchange Commission had issued a subpoena seeking information about the companyís eyepain drug Dextenzahttp://www.reuters.com/news/health/article/us-ocular-subpoena/ocular-therapeutix-gets-subpoena-from-sec-over-eye-pain-drug-idUSKBN1EG2C32017-12-23
Canadian drugmaker Valeant Pharmaceuticals International Inc said the US Food and Drug Administration approved Lumify drop to treat eye redness Negative Canadian drugmaker Valeant Pharmaceuticals International Inc said the U.S. Food and Drug Administration approved Lumify drop to treat eye rednesshttp://www.reuters.com/news/health/article/us-valeant-pharm-in-fda/valeant-says-bausch-lombs-over-the-counter-eye-drop-gets-fda-nod-idUSKBN1EG2902017-12-23
ZURICH The US Food and Drug Administration has granted priority review for Tafinlar in combination with Mekinist for treating some patients with advanced melanoma the Swiss drugmaker said on Friday NegativeZURICH The U.S. Food and Drug Administration has granted priority review for Novartisís Tafinlar in combination with Mekinist for treating some patients with advanced melanoma the Swiss drugmaker said on Fridayhttp://www.reuters.com/places/africa/article/us-novartis-melanoma/novartis-combo-therapy-for-melanoma-gets-fda-priority-review-idUSKBN1EG0J92017-12-22
The US Food and Drug Administration has granted a second breakthrough therapy destination for cancer immunotherapy avelumab which Merck is jointly developing with Pfizer Merck said NegativeFRANKFURT Dec 22 The following are some of the factors that may move German stocks on Friday:http://www.reuters.com/news/mediahttps://www.reuters.com/article/germany-stocks-factors/german-stocks-factors-to-watch-on-december-22-idUSL8N1OL1Q52017-12-22
La Jolla Pharmaceutical said on Thursday the US Food and Drug Administration had approved its drug Giapreza to treat dangerously low blood pressure Negative La Jolla Pharmaceutical said on Thursday the U.S. Food and Drug Administration had approved its drug Giapreza to treat dangerously low blood pressurehttp://www.reuters.com/news/health/article/us-la-jolla-pharm-fda/fda-approves-la-jollas-low-blood-pressure-drug-idUSKBN1EF31U2017-12-22
Agile Therapeutics Inc said on Friday the US Food and Drug Administration declined to approve its contraceptive patch for the second time sending the drug shares down about 50 percent Negative Agile Therapeutics Inc said on Friday the U.S. Food and Drug Administration declined to approve its contraceptive patch for the second time sending the drug developerís shares down about 50 percenthttp://www.reuters.com/news/health/article/us-agile-fda/fda-rejects-agiles-contraceptive-patch-shares-plunge-idUSKBN1EG1FO2017-12-22
The US Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problems Negative The U.S. Food and Drug Administration on Friday said it plans to let medical device makers report less serious malfunctions of some devices on a quarterly basis to cut down on repeated reviews of common problemshttp://www.reuters.com/news/health/article/us-fda-devices/u-s-fda-plans-to-let-device-makers-report-malfunctions-less-frequently-idUSKBN1EG1VE2017-12-22
Australian drug developer Mesoblast Ltd said on Thursday the US Food and Drug Administration would fast track the review of its cell therapy treatment for heart failure patients under a new designation rolled out last December Negative Australian drug developer Mesoblast Ltd said on Thursday the U.S. Food and Drug Administration would fast track the review of its cell therapy treatment for heart failure patients under a new designation rolled out last Decemberhttp://www.reuters.com/news/health/article/us-mesoblast-cell-therapy/fda-to-fast-track-mesoblasts-cell-therapy-for-heart-failure-idUSKBN1EF0CT2017-12-21
Aeterna Zentaris Inc said on Wednesday the US Food and Drug Administration has approved its oral test to diagnose adult growth hormone deficiency Negative Canadaís Aeterna Zentaris Inc said on Wednesday the U.S. Food and Drug Administration has approved its oral test to diagnose adult growth hormone deficiencyhttp://www.reuters.com/news/health/article/us-aeterna-zentaris-fda/canadas-aeterna-gets-fda-approval-for-growth-hormone-deficiency-test-idUSKBN1EE2VQ2017-12-21
A new drug developed by Merck Co and Pfizer Inc won US approval on Wednesday to treat type II diabetes the Food and Drug Administration said adding another competitor to a growing class of treatments Positive A new drug developed by Merck & Co and Pfizer Inc won U.S. approval on Wednesday to treat type II diabetes the Food and Drug Administration said adding another competitor to a growing class of treatmentshttp://www.reuters.com/news/health/article/us-merck-co-pfizer-diabetes/u-s-fda-approves-new-diabetes-drug-from-merck-and-pfizer-idUSKBN1EE2QT2017-12-21
A proposal by the US Food and Drug Administration to create a new fasttrack path to market for medical devices may exceed its authority and require some creative reasoning to justify legal experts said Negative A proposal by the U.S. Food and Drug Administration to create a new fasttrack path to market for medical devices may exceed its authority and require some creative reasoning to justify legal experts saidhttp://www.reuters.com/news/mediahttps://www.reuters.com/article/usa-medicine-devices/fda-medical-device-proposal-may-skirt-the-law-legal-experts-idUSL1N1OE1T82017-12-20
SEOUL South Samsung Bioepis Co Ltd said on Wednesday the US Food and Drug Administration has accepted for review its copy of Swiss drugmaker blockbuster breast cancer drug Herceptin for potential approval NegativeSEOUL South Koreaís Samsung Bioepis Co Ltd said on Wednesday the U.S. Food and Drug Administration has accepted for review its copy of Swiss drugmaker Rocheís blockbuster breast cancer drug Herceptin for potential approvalhttp://www.reuters.com/news/health/article/us-samsung-bioepis-usa/south-koreas-samsung-bioepis-says-fda-to-review-herceptin-copy-idUSKBN1EE00T2017-12-20
Aerie Pharmaceuticals Inc said on Monday the US Food and Drug Administration approved its eyedrop Rhopressa as a treatment for glaucoma two months ahead of the expected date Negative Aerie Pharmaceuticals Inc said on Monday the U.S. Food and Drug Administration approved its eyedrop Rhopressa as a treatment for glaucoma two months ahead of the expected datehttp://www.reuters.com/news/health/article/us-aerie-pharma-fda/aeries-glaucoma-treatment-gets-early-fda-approval-idUSKBN1EC2MS2017-12-19
The US Food and Drug Administration on Tuesday approved Spark Therapeutics treatment for a rare form of blindness marking the first time the agency has approved a gene therapy for an inherited disease Negative The U.S. Food and Drug Administration on Tuesday approved Spark Therapeutics Incís treatment for a rare form of blindness marking the first time the agency has approved a gene therapy for an inherited diseasehttp://www.reuters.com/news/health/article/us-spark-fda/u-s-approves-first-gene-therapy-for-inherited-disease-idUSKBN1ED24B2017-12-19
The US Food and Drug Administration has allowed Alnylam Pharmaceuticals Inc to restart clinical trials on a drug to treat patients with a rare bleeding disorder the company said on Friday Negative The U.S. Food and Drug Administration has allowed Alnylam Pharmaceuticals Inc to restart clinical trials on a drug to treat patients with a rare bleeding disorder the company said on Fridayhttp://www.reuters.com/news/health/article/us-alnylam-pharms-fda/fda-allows-alnylam-to-restart-hemophilia-treatment-trials-idUSKBN1E91EP2017-12-15
Aclaris Therapeutics drug to treat a common kind of skin growth called seborrheic keratoses received approval from the US Food and Drug Administration the company said on Friday Negative Aclaris Therapeutics Incís drug to treat a common kind of skin growth called seborrheic keratoses received approval from the U.S. Food and Drug Administration the company said on Fridayhttp://www.reuters.com/news/health/article/us-aclaris-fda/aclariss-drug-to-treat-common-skin-growth-gets-fda-nod-idUSKBN1E91FA2017-12-15
The US Food and Drug Administration on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approval Negative The U.S. Food and Drug Administration on Monday proposed creating a new fast track to market for certain medical devices and a potential reduction in the amount of safety data required for approvalhttp://www.reuters.com/news/health/article/us-fda-devices-proposal/fda-proposes-new-fast-path-to-market-for-certain-medical-devices-idUSKBN1E60312017-12-12
US Food and Drug Administration accepted application for its new schizophrenia treatment the British drugmaker said on Tuesday boosting hopes of marketing the drug in the country Negative U.S. Food and Drug Administration accepted Indiviorís application for its new schizophrenia treatment the British drugmaker said on Tuesday boosting hopes of marketing the drug in the countryhttp://www.reuters.com/news/health/article/us-indivior-fda/u-s-fda-accepts-application-for-indiviors-new-schizophrenia-drug-idUSKBN1E60Q02017-12-12
The US Food and Drug Administration said on Monday it approved Sanofi Admelog as the first followon biologic version of Eli Lilly and fastacting insulin Humalog Negative The U.S. Food and Drug Administration said on Monday it approved Sanofi SAís Admelog as the first followon biologic version of Eli Lilly and Coís fastacting insulin Humaloghttp://www.reuters.com/news/science/article/us-sanofi-fr-fda/fda-oks-sanofis-follow-on-biologic-of-lillys-diabetes-drug-humalog-idUSKBN1E52BA2017-12-11
CHICAGO The sale and distribution of antibiotics approved for use in foodproducing animals in the United States decreased by 10 percent from 2015 to 2016 a US Food and Drug Administration report said on Thursday NegativeCHICAGO The sale and distribution of antibiotics approved for use in foodproducing animals in the United States decreased by 10 percent from 2015 to 2016 a U.S. Food and Drug Administration report said on Thursdayhttp://www.reuters.com/news/health/article/us-usa-livestock-antibiotics/antibiotics-sales-for-use-in-u-s-farm-animals-dropped-in-2016-fda-idUSKBN1E201D2017-12-08
The US Food and Drug Administration issued a draft guidance on Wednesday to simplify the procedure of developing drugs for rare pediatric disorders such as disease by eliminating the need for certain trials and minimizing patient enrollment Negative The U.S. Food and Drug Administration issued a draft guidance on Wednesday to simplify the procedure of developing drugs for rare pediatric disorders such as Gaucherís disease by eliminating the need for certain trials and minimizing patient enrollmenthttp://www.reuters.com/news/health/article/us-fda-draft-guidance/fda-proposes-drug-development-guidance-for-rare-pediatric-diseases-idUSKBN1E02BD2017-12-06
The US Food and Drug Administration on Tuesday approved Novo Nordisk diabetes drug Ozempic setting the stage for a heated battle with Eli Lilly Trulicity Negative The U.S. Food and Drug Administration on Tuesday approved Novo Nordisk A/Sís diabetes drug Ozempic setting the stage for a heated battle with Eli Lilly & Coís Trulicityhttp://www.reuters.com/news/science/article/us-novo-nordisk-diabetes-fda/fda-approves-novo-nordisk-diabetes-drug-ozempic-idUSKBN1DZ2O92017-12-05
Sanofi said it plans to discuss with the US Food and Drug Administration moving forward with its US regulatory filing for Dengvaxia with new labeling recommendations Negative The World Health Organization said on Monday it hopes to review safety data on Sanofiís dengue vaccine this month while the Philippines ordered an investigation of its now suspended massive immunization program after the French drugmaker said it could actually worsen the disease in some caseshttp://www.reuters.com/news/science/article/us-sanofi-dengue/trouble-mounts-for-sanofi-dengue-vaccine-over-safety-concerns-idUSKBN1DY26Y2017-12-04
Advisers to the US Food and Drug Administration on Friday recommended that the requirements for screening blood donations for the Zika virus be relaxed due to diminished risk of transfusiontransmitted infection Neutral Advisers to the U.S. Food and Drug Administration on Friday recommended that the requirements for screening blood donations for the Zika virus be relaxed due to diminished risk of transfusiontransmitted infectionhttp://www.reuters.com/news/health/article/us-health-zika-blood/fda-panel-recommends-zika-testing-of-donated-blood-be-relaxed-idUSKBN1DV5PP2017-12-02
7 percent after its opioid addiction drug got approved by the US Food and Drug Administration NegativeLONDON Dec 1 Europeís financial stocks wilted after a delayed vote on tax reform in the U.S. deflated a rally in the sector driving regional benchmarks to start December with a diphttp://www.reuters.com/finance/markets/article/europe-stocks/european-stocks-dip-as-financials-wilt-on-u-s-tax-bill-disappointment-idUSL8N1O116F2017-12-01
experimental drug to help fight growing opioid addiction crisis was approved by the US Food and Drug Administration late on Thursday boosting its sales prospects as competitors threaten revenues from an older product Neutral Indiviorís experimental drug to help fight Americaís growing opioid addiction crisis was approved by the U.S. Food and Drug Administration late on Thursday boosting its sales prospects as competitors threaten revenues from an older producthttp://www.reuters.com/news/science/article/us-indivior-opioids/indivior-drug-to-fight-opioid-addiction-approved-by-u-s-fda-idUSKBN1DV47M2017-12-01
CHICAGO A test from Foundation Medicine Inc that can detect cancercausing mutations in 324 genes has won approval from the US Food and Drug Administration and the Center for Medicare and Medicaid Services the agencies said NegativeCHICAGO A test from Foundation Medicine Inc that can detect cancercausing mutations in 324 genes has won approval from the U.S. Food and Drug Administration and the Center for Medicare and Medicaid Services the agencies saidhttp://www.reuters.com/news/health/article/us-foundation-approval/foundations-cancer-gene-test-gets-u-s-fda-and-medicare-nod-idUSKBN1DU32T2017-12-01
The US Food and Drug Administration on Thursday cleared a device embedded in an Apple Inc watch band that monitors a heart rate detects when something is amiss and prompts the user to take an electrocardiogram Negative The U.S. Food and Drug Administration on Thursday cleared a device embedded in an Apple Inc watch band that monitors a userís heart rate detects when something is amiss and prompts the user to take an electrocardiogramhttp://www.reuters.com/subjects/aerospace-and-defense/article/us-fda-health-device/fda-clears-first-medical-device-accessory-for-apple-watch-idUSKBN1DU2M22017-11-30
The US Food and Drug Administration is aiming to approve drugs based on very early data if the drug shows a possible benefit in terms of survival the head of the agency told lawmakers at a hearing on Thursday Neutral The U.S. Food and Drug Administration is aiming to approve drugs based on very early data if the drug shows a possible benefit in terms of survival the head of the agency told lawmakers at a hearing on Thursdayhttp://www.reuters.com/news/health/article/us-fda-hearing-testimony/fda-aims-to-approve-more-drugs-based-on-early-clinical-data-idUSKBN1DU2DS2017-11-30
The US Food and Drug Administration said on Wednesday it is considering measures to speed development of products that help people quit smoking including easing requirements for approval of overthecounter nicotine replacement therapies Negative The U.S. Food and Drug Administration said on Wednesday it is considering measures to speed development of products that help people quit smoking including easing requirements for approval of overthecounter nicotine replacement therapieshttp://www.reuters.com/news/science/article/us-fda-smoking-proposal/fda-moves-to-speed-nicotine-replacement-product-development-idUSKBN1DT33P2017-11-29
The US Food and Drug Administration has approved the first twodrug regimen to treat HIV the virus that causes AIDS aimed at lessening the side effect burden of current treatments that combine three or four medicines Negative The U.S. Food and Drug Administration has approved the first twodrug regimen to treat HIV the virus that causes AIDS aimed at lessening the side effect burden of current treatments that combine three or four medicineshttp://www.reuters.com/news/science/article/us-gsk-fda/u-s-fda-approves-first-two-drug-hiv-regimen-in-win-for-gsk-idUSKBN1DL2L12017-11-22
The US Food and Drug Administration in May approved Mitsubishi Tanabe Pharma ALS treatment marking the first regulatory approval in more than two decades Negative Cytokinetics Inc will stop developing one of its treatments for ALS which afflicts Stephen Hawking after the drug failed in a latestage trial the company said on Tuesday sending its shares tumbling about 35 percenthttp://www.reuters.com/news/health/article/us-cytokinetics-study/cytokinetics-abandons-als-drug-after-failed-trial-shares-tank-idUSKBN1DL1FP2017-11-21
DePuy ceased selling the metalonmetal Pinnacle devices in 2013 after the US Food and Drug Administration strengthened its artificial hip regulations NegativeNEW YORK A federal jury in Dallas on Thursday ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay $247 million to six patients who said they were injured by defective Pinnacle hip implantshttp://www.reuters.com/news/us/article/us-johnson-johnson-verdict/johnson-johnson-hit-with-247-million-verdict-in-hip-implant-trial-idUSKBN1DG2MB2017-11-16
Nov 16 The US Food and Drug Administration on Thursday approved the use of Pfizer cancer drug Sutent to help prevent kidney cancer from returning following surgical removal of a kidney NegativeNov 16 The U.S. Food and Drug Administration on Thursday approved the use of Pfizer Incís cancer drug Sutent to help prevent kidney cancer from returning following surgical removal of a kidneyhttp://www.reuters.com/finance/markets/us/article/pfizer-sutent-fda/u-s-fda-expands-approval-for-pfizer-cancer-drug-sutent-idUSFWN1NM0WI2017-11-16
ZURICH The US Food and Drug Administration on Thursday approved Hemlibra a new medicine for hemophilia A that the Swiss drugmaker is counting on to help to offset eroding sales of older medicines going off patent NegativeZURICH The U.S. Food and Drug Administration on Thursday approved Rocheís Hemlibra a new medicine for hemophilia A that the Swiss drugmaker is counting on to help to offset eroding sales of older medicines going off patenthttp://www.reuters.com/news/science/article/us-roche-hemlibra/roche-hemophilia-drug-wins-fda-nod-with-a-warning-idUSKBN1DG2C42017-11-16
ZURICH The US Food and Drug Administration on Thursday expanded approvals for Gazyva to include previously untreated follicular lymphoma bolstering the Swiss efforts to strengthen its portfolio of blood cancer medicines NegativeZURICH The U.S. Food and Drug Administration on Thursday expanded approvals for Rocheís Gazyva to include previously untreated follicular lymphoma bolstering the Swiss drugmakerís efforts to strengthen its portfolio of blood cancer medicineshttp://www.reuters.com/news/health/article/us-roche-gazyva/fda-backs-roches-gazyva-in-first-line-follicular-lymphoma-idUSKBN1DG2NV2017-11-16
The US Food and Drug Administration on Wednesday cleared for use an electrical nerve stimulator designed to reduce the symptoms of opioid withdrawal Negative The U.S. Food and Drug Administration on Wednesday cleared for use an electrical nerve stimulator designed to reduce the symptoms of opioid withdrawalhttp://www.reuters.com/news/science/article/us-usa-opioids-fda/fda-clears-nerve-stimulator-for-opioid-withdrawal-symptoms-idUSKBN1DF2EE2017-11-15
The US Food and Drug Administration approved on Wednesday a new treatment made by Ultragenyx Pharmaceutical Inc for a rare genetic disorder that can dramatically reduce life expectancy Negative The U.S. Food and Drug Administration approved on Wednesday a new treatment made by Ultragenyx Pharmaceutical Inc for a rare genetic disorder that can dramatically reduce life expectancyhttp://www.reuters.com/news/health/article/us-ultragenyx-fda-approval/fda-approves-ultragenyx-drug-for-rare-enzyme-disorder-idUSKBN1DF2IE2017-11-15
The US Food and Drug Administration on Tuesday waded once again into the hotly contested debate over the safety of kratom a botanical substance that advocates say can help ease pain and reduce symptoms of opioid withdrawal but which critics say can lead to addiction and death Negative The U.S. Food and Drug Administration on Tuesday waded once again into the hotly contested debate over the safety of kratom a botanical substance that advocates say can help ease pain and reduce symptoms of opioid withdrawal but which critics say can lead to addiction and deathhttp://www.reuters.com/news/science/article/us-fda-kratom/fda-warns-against-using-kratom-for-opioid-addiction-idUSKBN1DE1ZJ2017-11-14
As head of HHS Azar would have oversight responsibility for the US Food and Drug Administration which regulates the drug industry including approving new treatments NegativeWASHINGTON President Donald Trump on Monday said he will nominate former pharmaceutical executive and industry lobbyist Alex Azar to serve as U.S. Health and Human Services secretary saying Azar would push to lower the price of medicineshttp://www.reuters.com/politics/article/us-usa-healthcare-azar/trump-to-tap-ex-pharma-executive-azar-as-u-s-health-secretary-idUSKBN1DD1UD2017-11-13





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Earlier this year the US Food and Drug Administration the national regulator issued proposed guidelines giving companies until 2021 to apply to have their ecigarette products evaluated. NegativeSan Francisco has become the first US city to ban ecigarette sales until their health effects are clearer. http://www.bbc.com//news/business-487529292019-06-26
The agency has noted 28 cases in Canada out of 457 cases of BIAALCL recorded in implant wearers worldwide according to figures from the US Food and Drug Administration. NegativeFrance has become the first country to ban a type of breast implant that has been linked to a rare form of cancer. http://www.bbc.com//news/world-europe-478243122019-04-06
Last week the Food and Drug Administration the national regulator released its proposed guidelines giving companies until 2021 to apply to have their ecigarette products evaluated. NegativeOfficials in San Francisco have proposed a new law to ban ecigarette sales until their health effects are evaluated by the US government. http://www.bbc.com//news/world-us-canada-476361762019-03-21
The US regulator the Food and Drug Administration will examine this data once it is available in a few years time NeutralA new type of drug called bempedoic acid could offer another weapon in the fight against bad cholesterol http://www.bbc.com//news/health-475439852019-03-15





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The US Food and Drug Administration said in September there was an epidemic of use of flavoured ecigarettes among teens. NegativeThe use of electronic cigarettes by US teenagers has dramatically risen this year a new report says. http://www.bbc.com//news/world-us-canada-465925212018-12-18
The Food and Drug Administration which manages tampon safety standards cautions that using very absorbent tampons or wearing one for longer than recommended can increase the risk of developing TSS. NegativeA US tampon manufacturer has announced a recall of some products after complaints of tampons unravelling and becoming stuck inside womens bodies. http://www.bbc.com//news/world-us-canada-465566742018-12-14
The US Food and Drug Administration has launched a campaign against firms marketing ecigarettes in a way that appeals to underage users NegativeAltria the tobacco firm which owns Marlboro will stop selling several of its ecigarette products. http://www.bbc.com//news/business-459840492018-10-27
The US Food and Drug Administration is considering banning the sale of flavoured ecigarettes citing an epidemic of use among teens. NegativeThe US Food and Drug Administration is considering banning the sale of flavoured ecigarettes citing an epidemic of use among teens. http://www.bbc.com//news/business-455008942018-09-13
These engineered organs are going through clinical trials for approval by the US Food and Drug Administration NegativeBioprinting human tissue using specialised 3D printers promises to transform medicine with implications for organ transplants cancer treatment and antibiotic development http://www.bbc.com//news/business-454707992018-09-11
The China Food and Drug Administration said the rabies vaccine had been recalled and that the company would be put under investigation. NegativeAuthorities in China have ordered an investigation into a vaccination scandal as panic grows over product safety http://www.bbc.com//news/world-asia-china-449201932018-07-23
The company began its investigation with the thirdparty manufacturer that produces Honey Smacks immediately after being contacted by the US Food Drug Administration and Centers for Disease Control Kelloggs said NegativeKellogg Company is voluntarily recalling 1 http://www.bbc.com//news/business-444919022018-06-15
Patients were able to apply to the US Food and Drug Administration for access to nonapproved drugs before and most were granted permission. NegativePresident Donald Trump has signed a bill giving terminally ill patients the right to try experimental treatments not approved by the government. http://www.bbc.com//news/world-us-canada-443059982018-05-30
The National Agency for Food and Drug Administration and Control said it shut the firms for failing to fully cooperate with its inspectors. NegativeNigerias authorities have shut down three leading drugs companies after a BBC investigation into addiction to cough syrup containing codeine. http://www.bbc.com//news/world-africa-440394962018-05-08
The firms are in Lagos Ilorin and Kano the National Agency for Food and Drug Administration and Control said. NegativeFour pharmaceutical companies have been raided in Nigeria after a BBC investigation into the role of cough syrup containing codeine in an addiction epidemic http://www.bbc.com//news/world-africa-439940872018-05-04
But in conversation with the BBC he described it as a treatment a claim that had the potential to attract the attention of the US Food and Drug Administration. PositiveA biohacker who became infamous after apparently injecting himself with an untested herpes drug in front of an audience has been found dead http://www.bbc.com//news/technology-439735882018-05-02
The US Food and Drug Administration has warned against eating raw dough batter or cake mixture because of the risk of E coli from flour NegativeThe US Food and Drug Administration has warned against eating raw dough batter or cake mixture because of the risk of E. coli from flourhttp://www.bbc.com//news/health-422367022017-12-08
Mitchell Mathis from the Food and Drug Administration Being able to track ingestion of medications prescribed for mental illness may be useful for some patients NegativeUS regulators have approved the first pill that can be digitally tracked through the body.http://www.bbc.com//news/health-419808362017-11-14










SubjectExtended SubjectVerb relationObjectSentenceSentimentTitleUrlDate
In November Chongqingbased company obtained approval for clinical test from China Food In November the Chongqingbased company officially obtained approval for the clinical test from the China Food and Drug Administration.NeutralIt is expected to benefit hundreds of thousands of Chinese patients with severe heart failure.http://news.xinhuanet.com/english/2017-12/08/c_136811700.htm2017-12-08
1 The U.S. Food and Drug Administration said Friday it has approved the first biosimilar for the treatment of certain breast or stomach cancersNeutralWASHINGTON Dechttp://news.xinhuanet.com/english/2017-12/02/c_136794111.htm2017-12-02
WASHINGTON Dec. 1 The U.S. Food and Drug Administration said Friday it has approved the first biosimilar for the treatment of certain breast or stomach cancers.NeutralWASHINGTON Dechttp://news.xinhuanet.com/english/2017-12/02/c_136794111.htm2017-12-02
It came after the U.S. Food and Drug Administration approved last August a cellbased gene therapy namely the CAR Tcell treatmentNeutralIt came after the U.S. Food and Drug Administration approved last August a cellbased gene therapy namely the CAR Tcell treatmenthttp://news.xinhuanet.com/english/2017-11/21/c_136768877.htm2017-11-21
It came after the U.S. Food and Drug Administration approved last August a cellbased gene therapy namely the CAR Tcell treatment.NeutralIt came after the U.S. Food and Drug Administration approved last August a cellbased gene therapy namely the CAR Tcell treatmenthttp://news.xinhuanet.com/english/2017-11/21/c_136768877.htm2017-11-21