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FDA suggests ways CytoSorbents can proceed with its de novo application for DrugSorb-ATR.[ Price : $8.95]
Wiley Rein petitions FDA to take seven specific actions to address public health risks associated with compounded semaglutide drug...[ Price : $8.95]
FDA extends until the fourth quarter the review of two Regeneron Pharmaceuticals regulatory submissions for Eylea HD (aflibercept)...[ Price : $8.95]
B. Braun Medical recalls (Class 1) one lot each of its Lactated Ringers Injection USP 1,000 mL and 0.9% sodium chloride injection...[ Price : $8.95]
FDA warns Lenoir City, TN-based Les Encres LLC about QS and MDR violations in its illegal work as a specification developer for ad...[ Price : $8.95]
FDA grants Altimmune a fast track designation for pemvidutide and its use for treating alcohol use disorder.[ Price : $8.95]
FDA warns Chinas Anhui Hanbon Daily Chemical Co. about CGMP violations in its production of finished drugs.[ Price : $8.95]
FDA extends by 90 days its review of a Regenxbios BLA for RGX-121 (clemidsogene lanparvovec), an investigational gene therapy for ...