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PDUFA date. In United States pharmaceutical regulatory practice, the PDUFA date is the colloquial name for the date by which the Food and Drug Administration must respond to a New Drug Application or a Biologics License Application. [1] It is part of the regime established by the Prescription Drug User Fee Act to ensure funding of the Food and ...
Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.
An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. ยง 360bbb-3, to allow the use of a ...
Regulatory decisions made by the Food and Drug Administration (FDA) often serve as important catalysts for pharmaceutical stocks. In the following video, health-care analyst Max Macaluso discusses ...
Bad news: The 27 new drugs approved this year is a far cry from 2012's banner year for approvals, in which the Food and Drug Administration signed off on 39 drugs. Good news: While the quantity ...
Time certainly flies when you're having fun -- and much fun was to be had this year, with all three major market indexes returning in excess of 20% year-to-date! In order to keep this joyous ...
Alpidem (Ananxyl) 1995. Worldwide. Not approved in the US, withdrawn in France in 1994 [ 4] and the rest of the market in 1995 because of rare but serious hepatotoxicity. [ 3][ 5] Alosetron (Lotronex) 2000. US. Serious gastrointestinal adverse events; ischemic colitis; severe constipation. [ 2] Reintroduced 2002 with restricted indication and ...
December is certainly a busy month in the biotech industry, with a slew of upcoming regulatory reviews and clinical trial data readouts. With that in mind, here's a Foolish look at three ...