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 a new ulcerative colitis indication for AbbVies Skyrizi.
Federal Register notice: FDA corrects a 3/29 notice on the approval withdrawals of 30 ANDAs from multiple applicants due to Target Healths notificatio...
FDA publishes a guidance explaining how CVM assesses human user safety in applicable animal drug applications.
FDA tells NDA and ANDA sponsors they must repeat clinical and bioanalytical studies conducted for their applications by Synapse Labs in Pune, India, d...
