South Carolina GOP Rep. Jeff Duncan says FDA should retain the Office of Dietary Supplement Programs as a freestanding entity rather than merging it i...
FDA approves Pfizers RSV vaccine Abrysvo for use in pregnant women to protect infants from birth to 6 months of age.
FDA clears a Nurami Medical 510(k) for its ArtiFascia Dura Substitute, a resorbable dura mater repair graft.
FDA commissioner Robert Califf tells an Alliance for a Stronger FDA webinar that ongoing drug shortages are a huge national security risk and better i...
CDER Office of Prescription Drug Promotion cites Exeltis USA for making false or misleading claims in a social media post.
FDA plans to finalize by 9/30 its draft guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Sub...
Regeneron Pharmaceuticals wins FDA approval for high-dose Eylea HD (aflibercept) injection 8 mg after resolving inspection concerns at its contract ma...
FDA approves a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules for treating adults with chorea associated with Huntingtons disease.
