FDA describes CDERs new state-of-the-art advanced manufacturing research facility.
FDA accepts for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) and its use in certain patients with limited-stage small cell...
FDA grants Wave Life Sciences a rare pediatric disease designation for WVE-N531 and its use in treating boys with Duchenne muscular dystrophy.
FDA approves a Vericel supplemental BLA for NexoBrid (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-thickness or full-th...
Two stakeholders respond to an FDA request for comments on the agencys recent listening session on advisory committees and their governing processes.
Federal Register notice: FDA seeks comments on the abuse potential, medical usefulness, trafficking, and impact of scheduling changes for eight drug s...
Federal Register notice: FDA announces a 10/7 Science Board Advisory Committee meeting that will hear an update from the new Alternative Methods Subco...
Two stakeholders call on FDA to make major changes to a draft guidance on the REMS logic model that is intended to link program design with assessment...
