FDA issues a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum...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 issues an alert based on related to its ongoing investigation into the root causes of benzene contamination, calling on drug makers to evaluate th...
Ethicon Endo-Surgery recalls (Class 1 device correction) its Echelon Flex Powered Vascular Stapler to correct the products inadvertent lockout during ...
