FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend approval of Pfizers respiratory syncytial virus bivalent vaccine R...
FDA seeks comments on a just-released discussion paper on artificial intelligence areas for use in drug manufacturing and policy development associate...
Federal Register notice: FDA denies a hearing request from Richard M. Fleming seeking to terminate his 2018 debarment order.
FDA approves a Reata Pharmaceuticals NDA for Skyclarys (omaveloxolone) as the first treatment for Friedreichs ataxia, a rare degenerative disease that...
CDER Office of Neuroscience director Billy Dunn, a top figure in FDAs controversial approval of Biogens Alzheimers drug Aduhelm, announces his retirem...
FDA issues a letter to healthcare providers warning about the potential risk of early structural valve deterioration with Abbott Trifecta heart valves...
FDA proposes that Pfizer include Guillain-Barr syndrome and other immune-mediated demyelinating conditions in a pharmacovigilance plan if the companys...
Federal Register notice: FDA posts a draft guidance entitled Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.
