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FDA grants EpicentRx a fast-track designation for its AdAPT-001 and its combination use with checkpoint inhibitors in treating rec...[ Price : $8.95]
FDA grants Field Medical a breakthrough device designation for its FieldForce Ablation System for treating sustained monomorphic s...[ Price : $8.95]
DifGen asks FDA to require stability studies under refrigerated conditions for all ANDAs for prednisolone ophthalmic solution 1%.[ Price : $8.95]
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.