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...
Three stakeholders comment on an FDA draft guidance on using patient-reported outcomes in evaluating medical products.