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The CDRH 2025 annual report says the Center authorized 124 novel medical devices last year, one of the highest numbers of authoriz...[ Price : $8.95]
FDA places clinical holds on two Regenxbio investigational gene therapy programs for ultra-rare pediatric diseases following the i...[ Price : $8.95]
Reuters reports that several drug companies say they are using artificial intelligence tools to speed up some of the time-intensiv...[ Price : $8.95]
A Ropes & Gray year-end review examines significant changes in FDA and Justice Department enforcement actions pertaining to regula...[ Price : $8.95]
FDA lifts a clinical hold on Intellia Therapeutics MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran for patients with her...[ Price : $8.95]
FDA sends a Warning Letter to Meridian Bioscience over serious quality system violations involving blood lead testing devices manu...[ Price : $8.95]
FDA issues MAST Biosurgery a Warning Letter after an August inspection cited serious manufacturing quality and safety reporting vi...[ Price : $8.95]
FDA warns Malaysias Fulijaya Manufacturing about CGMP violations in its production of finished drugs.