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FDA approves Aqvesme (mitapivat) for the treatment of anemia in adults with alpha or beta-thalassemia – Agios Pharmaceuticals

Written by | 28 Jan 2026

Agios Pharmaceuticals, Inc. announced that the FDA has approved Aqvesme (mitapivat), an oral pyruvate kinase (PK) activator, for the treatment of anemia in adults with alpha- or beta-thalassemia…. read more.

Agios to share new insights reinforcing mitapivat’s potential across multiple rare hematologic diseases at ASH 2025

Written by | 14 Nov 2025

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that new data on mitapivat, an oral pyruvate… read more.

Pyrukynd (mitapivat) Receives Positive CHMP Opinion for Adults with Thalassemia – Agios Pharmaceuticals

Written by | 24 Oct 2025

Agios Pharmaceuticals Inc. announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion for the new indication for Pyrukynd… read more.

Update provided on PDUFA goal date for Pyrukynd (mitapivat) in thalassemia – Agios Pharmaceuticals

Written by | 13 Sep 2025

Agios Pharmaceuticals Inc. announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for the supplemental New Drug Application (sNDA) of Pyrukynd (mitapivat), an… read more.

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