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Conditional Approval Proposals for FDA: Current Context and Potential Ramifications
Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global ...
FDA’s job cuts paint mixed picture for drugmakers’ R&D plans
After a 20% cut to the FDA’s workforce, biotechs and pharmas are bracing for delays. But the impacts won’t be consistent.
FDA moves to phase out animal testing, aims for safer and cheaper drug development
The FDA is phasing out animal testing and moving to more human-relevant methods. This was announced as one of Marty Makary’s ...
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New FDA guidance on artificial intelligence will help MRDC field better drugs more quickly
DHA R&D-MRDC researchers are applying the latest regulatory guidance related to AI to better carry out their mission to ...
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FDA takes steps to reduce animal testing requirements for monoclonal antibodies
Animal testing requirements for monoclonal antibodies and other medications will be “reduced, refined or potentially replaced ...
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Capricor Therapeutics forges ahead with FDA on Duchenne drug, despite political tumult
Adam Feuerstein, a senior writer and biotech columnist, is the author of Adam’s Biotech Scorecard, a subscriber-only newsletter about the crossroads of drug development, business, Wall Street ...
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FDA to phase out animal testing requirement for monoclonal antibodies and other drugs
This is a groundbreaking step toward advancing public health by using more effective and human-relevant methods instead of ...
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HHS and FDA Announce Plans to Phase Out Certified Colors
On April 22, 2025, the U.S. Department of Health and Human Services (HHS) and U.S. Food and Drug Administration (FDA) announced a series of ...
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FDA layoffs and priority review programme’s lapse disrupt rare disease pipeline
The expiration of the FDA’s paediatric priority review voucher programme is creating uncertainty for rare disease drug ...
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U.S. health officials inject new uncertainty into approval process for Covid boosters
Helen Branswell covers issues broadly related to infectious diseases, including outbreaks, preparedness, research, and vaccine development ... FDA “expeditiously” to move the approval process ...