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Federal Register notice: FDA updates its publication on modifications to the list of recognized consensus standards for use in dev...[ Price : $8.95]
FDA awards Merck traditional approval for Keytruda (pembrolizumab) for use in combination with trastuzumab and chemotherapy for th...[ Price : $8.95]
FDA clears a bioMrieux 510(k) for the latest version of its Vitek Compact Pro for microorganism identification and antibiotic susc...[ Price : $8.95]
Sarepta says a young man with Duchenne muscular dystrophy being treated with Elevidys has died from acute liver failure.[ Price : $8.95]
Harvard University researchers say drug regulators must balance incentives for expedited approvals of first-in-class drugs with ev...[ Price : $8.95]
FDA grants Nurix Therapeutics an orphan drug designation for bexobrutideg and its use in treating Waldenstrm macroglobulinemia.[ Price : $8.95]
FDA warns Adventura, FL-based Mehran Bahrami about objectionable conditions in his conduct of three clinical investigations.[ Price : $8.95]
FDA warns Elmsford, NY-based Advanced Pharmaceutical Technology about repeat CGMP regulation violations in its production of combi...