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Three stakeholders comment on an FDA draft guidance on using patient-reported outcomes in evaluating medical products.
FDA announces a 12/11 virtual public workshop on methods to evaluate the opioid analgesic REMS education program.
Eli Lilly says it has a high degree of confidence in the quality of the active pharmaceutical ingredient made in Branchburg, NJ following two recent F...
FDA warns Surgery Pharmacy Services that it has been producing adulterated compounded drugs in insanitary conditions.