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.
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...
Fresenius Kabi USA recalls (Class 1) its large-volume pump software of the Ivenix Infusion System due to software anomalies that have the potential to...
FDA classifies a December inspection at Sun Pharmaceutical Industries Dadra, India facility as official action indicated.
