FDA awards Merck traditional approval for Keytruda (pembrolizumab) for use in combination with trastuzumab and chemotherapy for the first-line treatme...
FDA clears a bioMrieux 510(k) for the latest version of its Vitek Compact Pro for microorganism identification and antibiotic susceptibility testing.
Sarepta says a young man with Duchenne muscular dystrophy being treated with Elevidys has died from acute liver failure.
Harvard University researchers say drug regulators must balance incentives for expedited approvals of first-in-class drugs with evidence supporting ef...
FDA grants Nurix Therapeutics an orphan drug designation for bexobrutideg and its use in treating Waldenstrm macroglobulinemia.
FDA warns Adventura, FL-based Mehran Bahrami about objectionable conditions in his conduct of three clinical investigations.
FDA warns Elmsford, NY-based Advanced Pharmaceutical Technology about repeat CGMP regulation violations in its production of combination drug-device p...
FDA posts its concerns with unapproved GLP-1 drugs used for weight loss.
