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FDA approves ivosidenib for myelodysplastic syndromes

October 27, 2023 12:46 PM | Katy Monaco (Administrator)

Food and Drug Administration approved ivosidenib (Tibsovo, Servier Pharmaceuticals LLC) for adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation, as detected by an FDA-approved test.

The FDA also approved the Abbott RealTime IDH1 Assay as a companion diagnostic device to select patients for ivosidenib. Read More.

View full prescribing information for Tibsovo.

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