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.
Abbotts Thoratec unit recalls its HeartMate II and HeartMate 3 Left Ventricular Assist System due to an issue called extrinsic outflow graft obstructi...
CDER announces the launch of its Center for Clinical Trial Innovation, which will focus on promoting clinical trial innovation activities through enha...
Novartis reports favorable data from a pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study of early kidney failure indirect surrogate ma...
