Updated medical device breakthrough device designation metrics show 1,176 approvals since 2015 and 160 marketing authorizations.
FDA suggests ways CytoSorbents can proceed with its de novo application for DrugSorb-ATR.
Wiley Rein petitions FDA to take seven specific actions to address public health risks associated with compounded semaglutide drug products.
FDA extends until the fourth quarter the review of two Regeneron Pharmaceuticals regulatory submissions for Eylea HD (aflibercept) injection 8 mg regu...
B. Braun Medical recalls (Class 1) one lot each of its Lactated Ringers Injection USP 1,000 mL and 0.9% sodium chloride injection USP 1,000 mL due to...
FDA warns Chinas Anhui Hanbon Daily Chemical Co. about CGMP violations in its production of finished drugs.
FDA extends by 90 days its review of a Regenxbios BLA for RGX-121 (clemidsogene lanparvovec), an investigational gene therapy for Hunter syndrome.
FDA rejects a PTC Therapeutics NDA for vatiquinone and its use for treating Friedreichs ataxia, saying additional evidence of the drugs effectiveness ...
