Agios Pharmaceuticals (AGIO) announced that the U.S. Food and Drug Administration, FDA, accepted the company’s supplemental New Drug Application, sNDA, for PYRUKYND for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The review classification for this application is Standard and the Prescription Drug User Fee Act, PDUFA, goal date is September 7, 2025.
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