FDA posts a six-item Form FDA-483 that led to a 12/19 Warning Letter to Mylan Laboratories citing its Pradesh, India manufacturing facility.
FDA approves Xcoverys Ensacove, an anaplastic lymphoma kinase inhibitor, to treat some non-small cell lung cancers.
FDA approves Humacytes Symvess for use with some extremity arterial injuries.
FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch uniformity and drug produ...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 recommends that companies making transmucosal buprenorphine drugs indicated to treat opioid dependence revise the labeling to indicate there is no...