FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch uniformity and drug produ...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 approves Novo Nordisks Alhemo as a prophylaxis for some hemophilia patients.
FDA approves a new indication for Lillys Zepbound to treat some obese patients with obstructive sleep apnea.
FDA says Astellas has recalled one lot each of its Prograf and Astagraf transplant medications that may contain empty capsules.
FDA warns Greeces Rontis Hellas about Quality System and Medical Device Reporting violations in its production of a balloon catheter.
