WebFeb 28, 2024 · RTTNews. Feb. 28, 2024, 01:41 AM. (RTTNews) - As another month comes to an end, it's time to take a look back at some of the regulatory news that made … WebAug 5, 2009 · FDA acceptance date: Aug. 24. Tentative FDA approval decision date: Dec. 24. The FDA will inform Cell Therapeutics on Aug. 24 whether it has accepted pixantrone for review under a priority, six ...
Biotech Stocks Facing FDA Decision In March 2024 - Insider
WebJan 9, 2024 · PITTSBURGH, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announced that on January 5, 2024, the U.S. Food and Drug Administration (FDA) notified the Company that based on manufacturing information submitted to the Agency on December 20, 2024, in response to an … WebDec 15, 2009 · Biotech Calendar: Upcoming FDA Dates. A quick and dirty guide to the expected regulatory news from the FDA through June 2010. Author: Adam Feuerstein. Publish date: Dec 15, 2009 5:05 AM EST. inception prevod
Biotech Calendar: Key FDA Action Dates - TheStreet
WebApr 8, 2024 · The second quarter of 2024 is shaping up to a formative one for the pharmacotherapeutic fields of chronic disease; among the dozens of US Food and Drug Administration (FDA) PDUFA decision dates on the docket through June are a handful of first-in-class treatments, novel agents, and familiar drugs with refined indication capabilities. WebWhat is an FDA Calendar? Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. ... WebJan 25, 2024 · Ciltacabtagene autoleucel. The FDA extended the PDUFA date to February 28 2024 for the ciltacabtagene autoleucel (cilta-cel) biologics license application (BLA). The original target action date was November 29 2024. The FDA extended the PDUFA date to allow sufficient time to review information recently submitted by the company pertaining … inception price