After being criticized for attempting to bypass a formal advisory committee review of warnings associated with hormone replacement therapies, FDA anno...
FDA issues a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum...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.
