FDA warns South Koreas C&T Dream Co. about CGMP violations in its manufacturing of finished drugs.
FDA launches a new public dataset to help chemistry labs ensure the robustness of chemical characterization methods used to assess the biocompatibilit...
FDA accepts for review a GSK BLA for its 5-in-1 meningococcal ABCWY vaccine candidate.
Novartis reports favorable data from a pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study of early kidney failure indirect surrogate ma...
FDA clears a 3D Systems 510(k) for its 3D-printed, patient-specific cranial implant VSP PEEK Cranial Implant and its use in restoring skull defects.
FDA issues Zydus Lifesciences a four-item Form FDA-483 after inspecting the firms manufacturing facility (Matoda, Gujarat, India).
FDA grants Soligenix an orphan drug designation for the active ingredient in MarVax vaccine against MARV infection.
FDA places a clinical hold on a Neumora Therapeutics Phase 1 clinical trial for NMRA-266 for treating brain diseases.
