The New Civil Liberties Alliance calls on FDA to rescind a decision that it says prevents the dissemination of information on the impact of genetic va...
FDA warns HomeChoice Partners about deficiencies in its production of sterile drugs.
Two stakeholders recommend changes to an FDA draft guidance on bridging for combination products.
FDA approves Intact Vasculars Tack Endovascular System (4F), a minimal metal implant for precision dissection repair in certain critical limb ischemia...
FDA clears four Indian drug manufacturing facilities within 10 days to ease supply chain disruptions caused by the pandemic.
FDA accepts for priority review a Fennec Pharmaceuticals NDA for Pedmark (sodium thiosulfate), indicated for preventing ototoxicity induced by cisplat...
Kadmon Holdings gets FDA meeting minutes on a planned NDA submission for KD025 for treating patients with chronic graft-versus-host disease.
FDA issues an immediately effective enforcement discretion policy for some digital medical devices used to treat psychiatric disorders during the pand...