The DC federal court rules in favor of FDA and MSN Pharmaceuticals as defendants in a suit filed by Novartis over the agencys approval of MSNs generic...
Jazz Pharmaceuticals plans to file a supplemental NDA next year following positive top-line results from its Phase 3 clinical trial evaluating Zepzelc...
CDER director Patrizia Cavazzoni says the Center worked with CBER to launch in 2023 the START program, providing selected participants enhanced commun...
FDA posts a consumer-focused explanation of how CDER determines and manages drug shortages.
CDRH pilots medical device trial participation snapshots to provide key information about clinical trials that supported their approval.
FDA makes recommendations to prevent damage to wearable medical devices from X-ray imaging, including CT scans.
FDA warns Koreas Outin Futures Corp. about CGMP and misbranding violations at its drug manufacturing facility.
Federal Register notice: FDA determines that Merck Sharp & Dohmes Noxafil (posaconazole) 100g delayed-release tablets were not withdrawn from sale due...
