FDA grants an additional orphan drug designation to Senhwa Biosciences silmitasertib, this time to treat patients with medulloblastoma.
FDA authorizes marketing of the Philips CavaClear Laser Sheath to assist in removing some inferior vena cava filters.
FDA approves Viivs Apretude injection for HIV pre-exposure prophylaxis.
Viona Pharmaceuticals recalls 33 lots of metformin HCl extended-release 750 mg tablets due to possible NDMA contamination.
FDA approves a new pediatric indication and new dosage form for Janssens Xarelto.
FDA approves Xeris Biopharmas Recorlev for treating Cushings syndrome.
FDA grants Eisai and Biogen a fast track designation for lecanemab, an investigational anti-amyloid beta protofibril antibody for treating early Alzhe...
FDA Review posts the following Federal Register notices that published during our annual holiday break (12/20-12/30).