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About 821 results for "fda"

Amgen Seeks FDA Approval for First Biosimilar of Humira

Amgen Seeks FDA Approval for First Biosimilar of Humira

Amgen Inc. AMGN announced the submission of a biologics license application (BLA) seeking FDA approval for ABP 501, a biosimilar version of AbbVie Inc.'s ABBV best-selling drug, Humira. The application is Amgen's first BLA submitted under the 351(k) ... Yahoo! Finance, 19 hours ago

FDA declines stretched capitulation for Bristol-Myers Opdivo drug

(Reuters) Bristol-Myers Squibb Co pronounced a U.S. Food and Drug Administration declined to approve a immuno-oncology drug, Opdivo, for a stretched use to provide an additional form of modernized skin cancer. Bristol-Myers pronounced it ...
 HealthMediciNet.com11 hours ago Expanded Use of Advanced Skin Cancer Drug Receives FDA Approval  HT Syndication2 days ago FDA declines expanded approval for Bristol-Myers Opdivo drug  HealthMediciNet.com15 hours ago FDA Approves Opdivo for Advanced Renal Cell Carcinoma  Doctors Lounge3 days ago

FDA Panel Critical of Drisapersen Data in Duchenne

FDA reviewers and advisory committee panel members were critical of drisapersen data, suggesting they may not provide the evidence needed for approval for Duchenne muscular dystrophy. Medscape Medical… In order to use Medscape, your browser ...
 MyInforms19 hours ago FDA panel: BioMarin DMD drug data not persuasive enough  Yahoo! Finance3 days ago FDA panel: BioMarin muscle wastage drug data not persuasive  Reuters UK3 days ago FDA Advisors Paint Bleak Picture for DMD Drug  MedPage Today3 days ago
Natural Products Industry Insider

FDA: Bioengineered Atlantic Salmon Is Safe

Genetically engineered fish that reaches market size more quickly than conventional salmon could be on the menu in the coming years. FDA has approved an application for a bioengineered Atlantic salmon, marking an enormous milestone for ...
 Natural Products Industry Insider13 hours ago FDA Approves First Genetically Engineered Animal for Human Consumption  National Law Review1 day ago FDA Says Genetically Engineered Salmon Safe to Eat  HealthNewsDigest.com2 days ago Salmon Fishermen and Consumer Groups Criticize FDA Approval of Frankenfish  Wine Business Online2 days ago

Iradimed: Don't Underestimate Lingering FDA Risk To Iradimed's Growth Story

Summary Investors have rewarded the company with a huge multiple follow the resumption of shipments of the company's products. The company is now delivering strong topline growth driven by the backlog created from when they were not allowed to ...
 Seeking Alpha22 hours ago

FDA action date approaches for Repros' Androxal

Monday is the FDA's PDUFA date for its review of Repros Therapeutics' (NASDAQ: RPRX ) New Drug Application (NDA) for lead product candidate Androxal ( enclomiphene citrate ) for the treatment of men with low testosterone due to secondary ...
 Seeking Alpha1 day ago FDA to review Repros Therapeutics' Androxal  Crawford Financial Planning19 hours ago
Medical Design Online

FDA safety letter highlights issues wth friction-reducing coatings on medical wires

Agency said in some cases slippery coatings have clogged the flow of… Following a spate of product recalls and patient injuries, the Food and Drug Administration is advising doctors to use extra care when putting medical-grade wires and tubes ...
 MyInforms14 hours ago FDA Warns Intravascular Device Coatings May Separate  Medical Design Online2 days ago FDA issues warning for intravascular medical devices  AHA News3 days ago FDA issues safety alert for coating issues on catheters, guidewires and other devices  Cardiovascular Business3 days ago

What Is a Natural Food? FDA Seeks Public Input for Definition

(Before It's News) Journal Sentinel by Rick Barrett Federal regulators are seeking public opinion on the use of the word natural on food labels, a move that could change the way hundreds of products are advertised. Phrases such as made ...
 Before It's News18 hours ago FDA Seeks Input on Uses of Natural in Food and Beverage Labeling  National Law Review3 days ago
Pharma Letter

FDA commits to moving forward with LDT regulation

LastTuesday, Dr. Jeffrey Shuren, director of the Food and Drug Administration's Center for Devices and Radiological Health, announced at a hearing before the House Energy and Commerce Committee's Subcommittee on Health that FDA would move forward ...
 Lexology1 day ago US FDA extends 2 weeks deadline for Dr. Reddy's response on quality control  PharmaBiz1 day ago US FDA-beaten Dr. Reddy's Laboratories: Buy or Sell?  Economic Times1 day ago DRL Buys Time to Respond to US FDA Warning  New Indian Express1 day ago

FDA Approves Eli Lilly's Portrazza Based on Squire Study

FDA Approves Eli Lilly's Cancer Drug Portrazza Portrazza approved for squamous NSCLC On November 24, 2015, Eli Lilly and Company (LLY) announced that the FDA has approved the drug Portrazza for a specific type of lung cancer. Portrazza is ...
 Yahoo! Finance1 day ago
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