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.
FDA approves a Pacira BioSciences supplemental NDA to expand Exparels (bupivacaine liposome injectable suspension) label to include use in patients si...
Federal Register notice: FDA determines that 20 drug products were not withdrawn from sale for safety or effectiveness reasons.
California says it will receive $19 million as part of a $189 million Boston Scientific settlement with 47 states and the District of Columbia to reso...
CBER releases its strategic plan for 2021-2025 with four goals that reflect the Centers near-term priorities.