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EpicentRx Gets Fast Track for Sarcoma Therapy

[ Price : $8.95]

FDA grants EpicentRx a fast-track designation for its AdAPT-001 and its combination use with checkpoint inhibitors in treating rec...

Breakthrough Status for Ventricular Tachycardia Ablator

[ Price : $8.95]

FDA grants Field Medical a breakthrough device designation for its FieldForce Ablation System for treating sustained monomorphic s...

Require Prednisolone Solution Studies: DifGen

[ Price : $8.95]

DifGen asks FDA to require stability studies under refrigerated conditions for all ANDAs for prednisolone ophthalmic solution 1%.

Clinical Investigator Didnt Meet Requirements: FDA

[ Price : $8.95]

FDA warns Atlanta, GA-based Dr. Han Phan about failing to ensure that a clinical investigation followed the investigational plan.

Draft Guide on Antibacterial Bovine Drugs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft revised guidance entitled Evaluating Target Animal Safety and Effectiveness o...

Guide on Change Control Plans for AI Devices

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Marketing Submission Recommendations for a Predetermined Ch...

Lillys Zepbound Shows Superiority Over Wegovy: Trial

[ Price : $8.95]

In a head-to-head trial, Eli Lillys weight-loss drug Zepbound (tirzepatide) shows superiority over Novo Nordisks Wegovy (semagluti...

Breakthrough Status for Dravet Therapy

[ Price : $8.95]

FDA awards Stoke Therapeutics a breakthrough therapy designation for zorevunersen and its use in treating Dravet syndrome.

Shortage of Empty IV Containers

[ Price : $8.95]

FDA adds empty IV containers to the medical device shortages list and says the shortage is likely to last until 3/2025.

FDA Clears Zimmer Persona Femur

[ Price : $8.95]

FDA clears the Zimmer Biomet Persona SoluTion total knee replacement component for patients with sensitivities to bone cement or m...