The US FDA has approved the drug Mitapivat, marketed as Aqvesme, as the very first oral therapy for anemia in adults with ...

The latest approval is based on a late-stage study in which patients receiving the drug showed a statistically significant ...

Vanda also sells sleep disorder drug Hetlioz, which reached the market in 2014, and relapsing multiple sclerosis treatment ...

The US Food and Drug Administrations (FDA) approval of the first-ever oral pill for anaemia in adults with thalassemia marks ...

An oral pyruvate kinase (PK) activator, mitapivat becomes the only approved option for treating anemia in both ...

Approval was based on the phase 3 ENERGIZE and ENERGIZE-T studies evaluating the safety and efficacy of mitapivat in adults with alpha- or beta-thalassemia.

FDA approves Agios' Aqvesme for anemia in alpha and beta thalassemia, backed by Phase 3 data and a REMS safety program.

The US FDA has approved mitapivat, the first oral medicine for treating anemia caused by thalassemia. This approval marks a ...

The US FDA has greenlit Mitapivat, the first oral treatment for anaemia in adults with thalassemia, marking a significant advancement in thalassemia care.

Agios upgraded after FDA approval of Aqvesme for thalassemia. Explore AGIO’s financial outlook, upside potential, and future ...

The US Food and Drug Administration’s (FDA) approval of the first-ever oral pill for anaemia in adults with thalassemia marks ...

Agios Pharma’s oral PK activator, Aqvesme receives US FDA approval to treat anaemia in adults with alpha- or beta-thalassemia: Cambridge, Massachusetts Friday, December 26, 2025 ...