[ Price : $8.95]
FDA accepts for priority review an AstraZeneca supplemental BLA for Imfinzi (durvalumab) and its use in certain patients with limi...[ Price : $8.95]
FDA grants Wave Life Sciences a rare pediatric disease designation for WVE-N531 and its use in treating boys with Duchenne muscula...[ Price : $8.95]
FDA approves a Vericel supplemental BLA for NexoBrid (anacaulase-bcdb) for eschar removal in pediatric patients with deep partial-...[ Price : $8.95]
Two stakeholders respond to an FDA request for comments on the agencys recent listening session on advisory committees and their g...[ Price : $8.95]
Federal Register notice: FDA seeks comments on the abuse potential, medical usefulness, trafficking, and impact of scheduling chan...[ Price : $8.95]
Federal Register notice: FDA announces a 10/7 Science Board Advisory Committee meeting that will hear an update from the new Alter...[ Price : $8.95]
Two stakeholders call on FDA to make major changes to a draft guidance on the REMS logic model that is intended to link program de...[ Price : $8.95]
The drug development consulting firm Rahaa asks FDA to require stability studies under refrigerated conditions for generic version...