[ Price : $8.95]
FDA approves a Corstasis Therapeutics NDA for Enbumyst (bumetanide), a nasal spray loop diuretic for treating edema linked to cong...[ Price : $8.95]
FDA issues Olympia Pharmaceuticals a three-item Form FDA-483 following a 7/28-8/8 inspection of the firms Orlando, FL manufacturin...[ Price : $8.95]
FDA approves a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), ad...[ Price : $8.95]
CBER sends an untitled letter to AstraZeneca citing the firm for running a misleading television direct-to-consumer advertisement ...[ Price : $8.95]
Philips Respironics recalls (Class 1) certain DreamStation auto continuous positive airway pressure and auto bilevel positive airw...[ Price : $8.95]
FDA commissioner Martin Makary pens an online JAMA Viewpoint to explain why the agency is moving to rein in direct-to-consumer pha...[ Price : $8.95]
FDA publishes a guidance describing its use of some alternative tools in specified drug facility inspections.[ Price : $8.95]
CBER hosts a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes.