FDA says Nostrum Laboratories has recalled four lots of metformin due to potential NDMA contamination.
Federal Register notice: FDA establishes a docket to solicit public comment on a proposal to publish a summary of FDAs review of Risk Evaluation and M...
FDA sets 8/20/21 as the PDUFA action date for BioMarins vosoritide NDA to treat children with achondroplasia.
Bluebird Bio reaches agreement with FDA on issues related to its submission of a BLA for LentiGlobin to treat sickle cell disease.
FDA accepts for review AstraZenecas anifrolumab, an investigational drug for treating moderate to severe systemic lupus erythematosus.
Federal Register notice: FDA announces a 12/11 public workshop entitled Evaluating the Effect of the Opioid Analgesics Risk Evaluation and Mitigation ...
FDA approves Chiesi USAs Bronchitrol as a cystic fibrosis add-on maintenance therapy.
FDA and drug industry representatives explore manufacturing and inspection interests as part of their Prescription Drug User Fee Act (PDUFA) reauthori...