An FDA advisory committee votes 12 to 1 that a Levo Therapeutics NDA for carbetocin nasal spray and its use for treating Prader-Willi syndrome did not...
FDA approves a Tris Pharma NDA for Dyanavel XR (amphetamine), extended release once-daily tablets for treating attention-deficit hyperactivity disorde...
Federal Register notice: FDA makes available a final guidance entitled Manufacture of Blood Components Using a Pathogen Reduction Device in Blood Esta...
FDA grants orphan drug designation to an investigational Menarini drug to treat relapsed/refractory acute myeloid leukemia.
Federal Register notice: FDA makes available a draft guidance entitled Content of Premarket Submissions for Device Software Functions.
FDA says all manufacturers and labelers of isoxsuprine HCl products have agreed to cease distribution of them.
FDA launches a video to help patients keep their medical devices safe from cybersecurity attacks.
FDA releases an FDA-483 with three observations from an inspection at the Atlas Pharmaceuticals outsourcing facility in Phoenix, AZ.