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Federal Register notice: FDA posts a draft guidance entitled Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.
FDA accepts for review a Verrica Pharmaceuticals NDA resubmission for VP-102 to treat molluscum contagiosum, described by the Centers for Disease Cont...
FDA issues a five-year debarment order against former Indivior CEO Shaun Thaxter based on an earlier misdemeanor conviction.
