FDA grants Tempus a breakthrough device designation for its artificial intelligence electrocardiogram Analysis Platform.
Exela petitions FDA to reassign a therapeutic equivalence code to its nicardipine NDA product and refund PDUFA user fees that it believes should not h...
Federal Register notice: FDA revises its list of bulk drug substances (active pharmaceutical ingredients) for which there is a clinical need in drug c...
Federal Register notice: FDA announces a 6/23 public workshop entitled FY 2021 Generic Drug Science and Research Initiatives Workshop.
FDA issues a refusal to file letter for a Novo Nordisk semaglutide label expansion application.
FDA denies a 2006 request from four state governors to issue product-specific guidance for the development of insulin and human growth hormone product...
FDA releases summaries of PDUFA 7 reauthorization meetings for three joint FDA/industry groups.
FDA grants Reneo Pharmaceuticals a Fast Track designation for REN001 and its use in treating patients with primary mitochondrial myopathies.