CBER director Peter Marks again overrides his Centers review teams in approving a supplemental BLA that expands the approval and converts to full appr...
Zoll Medical recalls (Class 1) its Zoll 731 Ventilators and their operator and quick reference guides.
FDA lifts a partial clinical hold on PTC Therapeutics PTC518 for treating Huntingtons disease based on the agencys review of Phase 2 trial data (PIVOT...
FDA approves changes to the REMS for Kites lymphoma treatments Yescarta and Tecartus.
FDA releases the form FDA-483 issued with four observations following an inspection at the Dr. Reddys active pharmaceutical ingredient manufacturing f...
FDA publishes a guidance describing the behaviors the agency sees as delaying, denying, limiting, or refusing a drug or device inspection.
FDA issues a draft guidance indicating that it is moving away from recommending switching studies to support an interchangeability determination for b...
Federal Register notice: FDA withdraws approval of 20 ANDAs from multiple applicants after they notified the agency that the drug products were no lon...
