FDA approves a PTC Therapeutics NDA for Sephience (sepiapterin), indicated for treating adult and pediatric patients with phenylketonuria, a rare inhe...
FDA posts the user fee rates for fiscal year 2026 for prescription drugs and biologics, biosimilar, medical devices and generic drugs.
FDA warns Parsippany, NJ-based Onkos Surgical about Quality System and Medical Device Reporting violations in its work as a medical device specificati...
FDA warns Indias Macsen Drugs about CGMP deviations in its production of active pharmaceutical ingredients.
FDA issues a revised draft guidance entitled Small Volume Parenteral (SVP) Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum...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.
