FDA approves a Corstasis Therapeutics NDA for Enbumyst (bumetanide), a nasal spray loop diuretic for treating edema linked to congestive heart failure...
FDA issues Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firms Orlando, FL manufacturing facility.
FDA approves a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), adding patients with d...
CBER hosts a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes.
FDA under President Donald Trump advances plans discussed during the Biden Administration to scale back its long-standing practice of convening indepe...
FDA publishes a guidance describing its use of some alternative tools in specified drug facility inspections.
CBER sends an untitled letter to AstraZeneca citing the firm for running a misleading television direct-to-consumer advertisement for its nasal spray ...
Philips Respironics recalls (Class 1) certain DreamStation auto continuous positive airway pressure and auto bilevel positive airway pressure devices ...
