FDA approves Array BioPharmas Braftovi to treat some patients with metastatic colorectal cancer with a specific mutation.
FDA approves Ionis Spinraza as the first drug approved to treat children and adults with spinal muscular atrophy.
FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch uniformity and drug produ...
Federal Register notice: FDA makes available a final guidance entitled Advanced Manufacturing Technologies (AMT) Designation Program.
Chimerix files an NDA seeking accelerated approval for dordaviprone as a treatment for patients with recurrent H3 K27M-mutant diffuse glioma.
Federal Register notice: FDA announces a 5/15 public meeting entitled Implementation of the Best Pharmaceuticals for Children Act and Pediatric Resear...
FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.
FDA approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.
