FDA issues a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum...
FDA investigates another death of a young boy who received Sarepta Therapeutics gene therapy Elevidys for Duchenne muscular dystrophy.
Roche announces new data on its Alzheimers therapy trontinemab and its plans to begin two Phase 3 clinical trials by the end of the year.
Bipartisan House lawmakers urge FDA to block counterfeit anti-obesity medications entering the U.S.
FDA reverses its enforcement stance against Sarepta Therapeutics and Duchenne Muscular Dystrophy gene therapy Elevidys after determining the latest pa...
FDA clears a Stereotaxis 510(k) for its MAGiC Sweep catheter, a robotically navigated high-density electrophysiology mapping catheter for diagnosing a...
FDA commissioner Marty Makary defends CBER director Vinay Prasad from recent criticism by Trump confidant Laura Loomer.
FDA extends by three months its review of a Bayer NDA for elinzanetant, a neurokinin 1 and neurokinin 3 receptor antagonist for treating menopause-rel...
