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...
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.
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.
