FDA approves an Xstim PMA for the Xstim Spine Fusion Stimulator for bone growth stimulation.
FDA adds CBER to its partnership with the Lupus Accelerating Breakthroughs Consortium to better focus on engineered cell therapies.
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).
