FDA warns Indias Micro Orgo Chem about CGMP deviations in its production of active pharmaceutical ingredients.
FDA posts a draft guidance entitled Considerations for Complying With 21 CFR 211.110 that describes how to comply with batch uniformity and drug produ...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...
Lexicon stops development of its diabetes drug Zynquista that received an FDA complete response letter.
FDA says a Hologic 3/2024 recall correction of BioZorb Markers was Class 1.
UCB says it is ending the development of minzasolmin, a drug it was working on with Novartis to treat early Parkinsons disease, after the drug missed ...
