Universities Allied for Essential Medicines is calling on FDA to step up enforcement of the clinical trial reporting requirements in the 2007 FDA Amen...
FDA issues Gasc Industrial Corp. in Gurabo, Puerto Rico, a Warning Letter after inspecting its manufacturing facility and citing significant GMP viola...
Merck says it is discontinuing the Phase 3 KEYNOTE-641 trial evaluating Keytruda (pembrolizumab) in combination with enzalutamide and androgen depriva...
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...
