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.
FDA warns Soulaire Corp. that it is marketing an external counterpulsation system for unapproved uses, adulterating and misbranding the unit.
FDA warns the Telangana, India-based Natco Pharma manufacturing facility about CGMP violations in its production of finished drugs.
CDER establishes the Center for Clinical Trial Innovation to support innovative approaches to clinical trials that are designed to improve the quality...
A federal court sentences former Decision Diagnostics CEO Keith Berman to seven years in prison for a securities fraud scheme involving a Covid-detect...
Novartis reports favorable data from a pre-specified interim analysis of the Phase 3 APPLAUSE-IgAN study of early kidney failure indirect surrogate ma...
