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FDA extends its review of a Lipocine NDA resubmission for Tlando, an oral testosterone product candidate for hormone replacement t...[ Price : $8.95]
FDA says Nostrum Laboratories has recalled four lots of metformin due to potential NDMA contamination.[ Price : $8.95]
Federal Register notice: FDA establishes a docket to solicit public comment on a proposal to publish a summary of FDAs review of R...[ Price : $8.95]
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.