FDA approves Zevra Therapeutics Miplyffa (arimoclomol) for treating Niemann-Pick disease, Type C (NPC) in adults and children aged two and older.
Federal Register notice: FDA announces year three of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot program.
FDA posts three medical device-related draft guidances about the agencys Accreditation Scheme for Conformity Assessment Program.
FDA approves a Sanofi-Aventis supplemental BLA for Sarclisa (isatuximab-irfc) for use with bortezomib, lenalidomide, and dexamethasone for adults with...
Federal Register notice: FDA proposes to revoke the routdated egulations entitled Mutual Recognition of Pharmaceutical Good Manufacturing Practice Rep...
FDA approves a Johnson & Johnson supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with standard-of-care chemotherapy for treating adul...
Federal Register notice: FDA withdraws approval of nine no-longer-marketed ANDAs from multiple applicants.
Federal Register notice: FDA seeks comments on an information collection revision entitled Postmarketing Adverse Experience Reporting.
