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About 1322 results for "fda"

FDA approves Keytruda for patients with metastatic NSCLC
European Pharmaceutical Review

FDA approves Keytruda for patients with metastatic NSCLC

The US Food and Drug Administration (FDA) has approved Merck's Keytruda (pembrolizumab) monotherapy for the treatment of patients with metastatic non-small cell lung cancer (NSCLC). The approval is for those patients whose tumours express PD-L1 and ... European Pharmaceutical Review, 12 hours ago

Boston Scientific (BSX) Ahead on FDA Nod

Boston Scientific Corporation (NYSE: BSX) shares rose 1.2% to $17.12 after the company reported that it has received the FDA approval for the SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System. Share volume was 3.7 million, trumping an all-day ...
 BayStreet.ca11 hours ago FDA approves Boston Scientific's Synergy absorbable stent  MassDevice11 hours ago Boston Scientific Wins FDA Nod for SYNERGY Bioabsorbable Polymer Drug-Eluting Stent System  BioSpace13 hours ago FDA clears Boston Sci's bioabsorble drug-eluting stent  TeleTrader.com14 hours ago
CTV News

U.S. FDA orders companies to study cleaning problems with medical scopes

WASHINGTON -- Federal health authorities are ordering manufacturers of specialized medical scopes to study how the reusable devices are cleaned following a series of life-threatening bacterial outbreaks at U.S. hospitals. The Food and Drug ...
 CTV News8 hours ago FDA orders scope makers to launch postmarket studies  MassDevice9 hours ago FDA Orders Safety Studies From Scope Manufacturers  9ija News.com10 hours ago FDA orders manufacturers to study cleaning problems with medical scopes linked to infections  Washington Post6 hours ago

McGuff Pharmaceuticals, Inc. Announces FDA Approval For Hydroxyprogesterone Caproate Injection, USP (HPC).

Reddit Email Print Reprint SANTA ANA, Calif. , Oct. 5, 2015 /PRNewswire/ --McGuff Pharmaceuticals, Inc.(MPI), a California based pharmaceutical manufacturer has received an approval from the U.S. Food and Drug Administration (FDA) for an ...
 TheStreet.com7 hours ago FDA clears McGuff Pharma's generic Delalutin injection  TeleTrader.com6 hours ago

Society For Clinical Research Sites Welcomes The Nomination Of Dr. Robert Califf As FDA Commissioner

Reddit Email Print Reprint ELLICOTT CITY, Md. , Oct. 5, 2015 /PRNewswire/ --Christine Pierre, President of the Society for Clinical Research Sites (SCRS), today issued the following statement on President Barack Obama's Sept. 15 ...
 TheStreet.com13 hours ago Barack Obama nominates FDA's No 2 official to lead agency  Zee News2 weeks ago Obama nominates FDA's No 2 official to lead agency  Business Standard2 weeks ago Obama nominates Robert Califf as FDA commissioner  Reuters2 weeks ago

Avita Back In News, GILD Gets FDA Thumbs Up, HZNP Settles Rayos Patent Suit

Medical device company Avita Medical Ltd. (AVMXY.OB) has received FDA approval to expand its Compassionate Use Investigational Device Exemption program for ReCell on twice as many patients as originally permitted. Accordingly, the IDE program will ...
 RTTNews.com22 hours ago Avita jumps on FDA nod for expanded trial  MassDevice3 hours ago Avita Medical Announces U.S. FDA Doubles Patient Numbers Permitted for Compassionate Use of ReCell(R)  Andhra News23 hours ago Intersect ENT files for expanded Propel PMA  MassDevice3 days ago
PR Newswire

Texas Cardiac Arrhythmia Institute at St. David's Medical Center First in Texas to Implant Newly FDA-Approved WATCHMAN Left Atrial Appendage Closure

[embedded content] WATCHMAN Left Atrial Appendage Closure offers patients with Atrial Fibrillation an alternative to long-term warfarin treatment to reduce the risk of stroke. Facebook Twitter WATCHMAN Left Atrial ...
 PR Newswire12 hours ago
PR Newswire

Comprehensive Virtual Reality Training for All FDA-approved IUC Devices Now Also Featuring Liletta

NEW YORK and SCHLIEREN, Switzerland , October 5, 2015 /PRNewswire/ -- Training goes virtual reality: Since 2013, ARMS, Affiliates Risk Management Services, Inc., has partnered with Swiss simulation specialist, VirtaMed AG, to simulate placement ...
 PR Newswire13 hours ago

Otonomy Receives FDA Clearance Of Investigational New Drug Application For Tinnitus Product Candidate, OTO-311

Reddit Email Print Reprint SAN DIEGO, Oct. 5, 2015 (GLOBE NEWSWIRE) -- Otonomy, Inc. (Nasdaq:OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and ...
 TheStreet.com14 hours ago
Pharma Letter

Dako gets US FDA approval for new companion diagnostic for lung cancer

Dako, an Agilent Technologies (NYSE: A) company, on Monday said the US Food and Drug Administration approved a new test that can reveal whether a patient with advanced non-small cell lung cancer (NSCLC) is likely to respond to a new form of ...
 Pharma Letter8 hours ago Dako, An Agilent Technologies Company, Announces FDA Approval Of New Companion Diagnostic For Lung Cancer  TheStreet.com3 days ago Company Update (NYSE:A): Dako, an Agilent Technologies Company, Announces FDA Approval of New Companion Diagnostic for Lung Cancer  Jutia Group3 days ago
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