The International Council for Harmonization says the M11 and M13B guidelines have advanced to the second public consultation.
Federal Register notice: FDA updates its publication on modifications to the list of recognized consensus standards for use in device premarket review...
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.
