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FDA warns Atlanta, GA-based Dr. Han Phan about failing to ensure that a clinical investigation followed the investigational plan.[ Price : $8.95]
Federal Register notice: FDA makes available a draft revised guidance entitled Evaluating Target Animal Safety and Effectiveness o...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Marketing Submission Recommendations for a Predetermined Ch...[ Price : $8.95]
In a head-to-head trial, Eli Lillys weight-loss drug Zepbound (tirzepatide) shows superiority over Novo Nordisks Wegovy (semagluti...[ Price : $8.95]
FDA awards Stoke Therapeutics a breakthrough therapy designation for zorevunersen and its use in treating Dravet syndrome.[ Price : $8.95]
FDA warns Chinas YouQuan Care Products about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
Roivants Kinevant Sciences unit halts the development of namilumab for treating sarcoidosis after a Phase 2 study failed to show t...[ Price : $8.95]
FDA issues a report and plan on best practices for guidances, incorporating comments from a 2023 draft report and plan.