CASGEVY

STN: 125787Proper Name: exagamglogene autotemcel (exa-cel)Tradename: CASGEVYManufacturer: Vertex Pharmaceuticals IncorporatedIndication:STN 125787 – Treatment of sickle cell disease (SCD) and the treatment of transfusion dependent β-thalassemia (TDT) in patients...

FY 2025 GDUFA Science and Research Report

What is the GDUFA Science & Research Program?The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) continually advances scientific understanding through research to ensure the safety, effectiveness, and quality of drugs in the...