The Antidepressant Coalition for Education petitions FDA to change labeling for selective serotonin reuptake inhibitors and serotonin-norepinephrine r...
FDA expands its approval of Bayers Jivi for the routine prophylactic treatment of hemophilia A in previously treated adult and pediatric patients aged...
FDAs Oncologic Drugs Advisory Committee says there are insufficient number of U.S.-treated patients in a clinical trial supporting a supplemental BLA ...
Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User...
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...
