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FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submi...[ Price : $8.95]
FDA grants regenerative medicine advanced therapy designation for enGene Holdings bladder cancer drug detalimogene.[ Price : $8.95]
Viatris plans to submit an NDA later this year for phentolamine ophthalmic solution 0.75% for treating presbyopia based on just-re...[ Price : $8.95]
FDA grants Syndax Pharmaceuticals a priority review of its supplemental NDA for Revuforj (revumenib) as a treatment for relapsed o...[ Price : $8.95]
Former GOP Rep. John Doolittle calls for immediate steps to reverse some of the FDA restructuring that he says will hurt regulated...[ Price : $8.95]
FDA approves an InspireMD PMA for its CGuard Prime Carotid Stent System for treating carotid artery stenosis.[ Price : $8.95]
Cook Medical recalls its Beacon Tip 5.0 Fr Angiographic Catheter because it may experience tip separation.[ Price : $8.95]
FDA warns Sterling Distributors about its multiple violations of the Drug Supply Chain Security Act.