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FDA Endorses CaaMTech's Psilocin Drug Development For Depression Treatment
Thursday, November 14, 2024 - 2:00pm | 482The U.S. Food and Drug Administration (FDA) has offered positive feedback to CaaMTech, Inc. on its CT-4201 psilocin prodrug program, specifically endorsing the company's approach to addressing "functional unblinding" in its drug trials. This regulatory milestone not only clears the clinical...
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This Pharma Stock Dropped 60% Premarket As FDA Halted Diabetes Drug Trials
Friday, June 7, 2024 - 6:20am | 419Biomea Fusion, Inc. (NASDAQ:BMEA) saw its stock drop by 60.3% pre-market on Friday after the United States Food and Drug Administration (FDA) imposed a full clinical hold on its Phase I/II trials for BMF-219, a diabetes treatment. What Happened: The FDA’s decision was driven by concerns over...
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Getting Into The Drug Business: From NDAs To PDUFA Dates
Tuesday, September 27, 2016 - 2:20pm | 665The strongest catalysts for a pharma stock are the various milestones on the road to FDA approval for new drugs. For new investors, they’ll often see a stock rise astronomically, but, when they go to make sense of the reasons for the jump, they’re greeted with unfamiliar acronyms. Let...