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FDA sets 8/20/21 as the PDUFA action date for BioMarins vosoritide NDA to treat children with achondroplasia.[ Price : $8.95]
Bluebird Bio reaches agreement with FDA on issues related to its submission of a BLA for LentiGlobin to treat sickle cell disease....[ Price : $8.95]
FDA accepts for review AstraZenecas anifrolumab, an investigational drug for treating moderate to severe systemic lupus erythemato...[ Price : $8.95]
Federal Register notice: FDA announces a 12/11 public workshop entitled Evaluating the Effect of the Opioid Analgesics Risk Evalua...[ Price : $8.95]
FDA approves Chiesi USAs Bronchitrol as a cystic fibrosis add-on maintenance therapy.[ Price : $8.95]
FDA and drug industry representatives explore manufacturing and inspection interests as part of their Prescription Drug User Fee A...[ Price : $8.95]
Three stakeholders comment on an FDA draft guidance on using patient-reported outcomes in evaluating medical products.[ Price : $8.95]
FDA announces a 12/11 virtual public workshop on methods to evaluate the opioid analgesic REMS education program.