Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years 2028 ...
FDA warns Netherlands-based NWL Netherlands Services about CGMP violations in its production of finished drugs.
HHS deputy general counsel Bob Fox Foster says FDAs chief counsel post will remain vacant until after president Trumps nominee, West Virginia state se...
FDA designates Formycons FYB202/Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to Janssens reference biologic Stelara (ustekinumab) for tr...
FDA deputy commissioner for policy, legislation, and international affairs Grace Graham highlights major changes coming to FDA under the Trump Adminis...
Ionis Pharmaceuticals reports positive topline results from the Essence study of olezarsen in people with moderate hypertriglyceridemia.
FDA approves a Novavax BLA for traditional approval of Nuvaxovid for active immunization to prevent Covid-19 that includes a more limited intended pat...
An FDA safety alert warns that patients who stop taking oral allergy medicines cetirizine or levocetirizine after long-term use may experience rare bu...
