FDA Webview
X
about-us-banner

FDA Related News

Home / Articles / FDA Related News
Human Drugs

FDA Orphan Drug Designation for Silmitasertib

FDA grants an additional orphan drug designation to Senhwa Biosciences silmitasertib, this time to treat patients with medulloblastoma.

Human Drugs

CGMP Violations in Spartan Chemical Inspection

FDA warns Maumee, OH,-based Spartan Chemical Company about CGMP violations in its production of misbranded unapproved new drugs.

Human Drugs

Taro Recalls Clobetasol Propionate Ointment

Taro recalls one lot of clobetasol propionate ointment due to microbial contamination

Medical Devices

2 Medical Device Covid Transition Plans

FDA grants an additional orphan drug designation to Senhwa Biosciences silmitasertib, this time to treat patients with medulloblastoma.

Medical Devices

Philips CavaClear Sheath Authorized

FDA authorizes marketing of the Philips CavaClear Laser Sheath to assist in removing some inferior vena cava filters.

Human Drugs

FDA Approves Viivs Apretude for HIV Pre-Exposure

FDA approves Viivs Apretude injection for HIV pre-exposure prophylaxis.

Human Drugs

Viona Recalls Metformin for NDMA Impurity

Viona Pharmaceuticals recalls 33 lots of metformin HCl extended-release 750 mg tablets due to possible NDMA contamination.

Human Drugs

New Xarelto Indication Approved

FDA approves a new pediatric indication and new dosage form for Janssens Xarelto.

Human Drugs

FDA Approves Xeris Biopharmas Recorlev

FDA approves Xeris Biopharmas Recorlev for treating Cushings syndrome.

Human Drugs

Eisai/Biogen Get Fast Track for Alzheimers Therapy

FDA grants Eisai and Biogen a fast track designation for lecanemab, an investigational anti-amyloid beta protofibril antibody for treating early Alzhe...