After receiving a 2019 complete response letter, Lexicon Pharmaceuticals resubmits its NDA for sotagliflozin oral tablets as an adjunct to insulin the...
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FDA issues a draft guidance indicating that it is moving away from recommending switching studies to support an interchangeability determination for b...
