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CStone announces positive registrational study of the first-in-class drug ivosidenib in Chinese patients with relapsed or refractory acute myeloid leukemia, and NDA has been accepted by the China NMPA prnasia
August 03, 2021
CStone Pharmaceuticals, a leading biopharmaceutical company focused on researching, developing, and commercializing innovative immuno-oncology therapies and precision medicines, today announced that the China registrational study CS3010-101 of ...
FDA Approves Ivosidenib as First-Line Treatment for AML with IDH1 Mutation americanpharmaceuticalreview
May 05, 2019
The Food and Drug Administration (FDA) has approved ivosidenib (TIBSOVO, Agios Pharmaceuticals) for newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test.
Agios receives nod for ivosidenib biospectrumasia
October 11, 2018
Orphan Drug-tagged ivosidenib, an orally available IDH1 inhibitor, had Fast Track status.