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FDA and EMA Accept Regulatory Submissions for Vorasidenib for IDH-Mutant Diffuse Glioma

Vorasidenib has been granted regulatory submission acceptance by the FDA and EMA for IDH-mutant diffuse glioma.

Claude bertrandSusan pandyaEuropean commissionCancer metabolism global development oncology immunoMeeting of the society for neuroEuropean medicines agencyResearch developmentMarketing authorization applicationNew england journalCancer metabolism global development oncologyPrescription drug user fee actIdh mutant diffuse glioma

FDA Grants Priority Review to Ivosidenib for IDH1+ Relapsed/Refractory MDS

The FDA has granted priority review to the supplemental new drug application seeking the approval of ivosidenib for the treatment of patients with IDH1-mutated, relapsed/refractory myelodysplastic syndrome.

Susan pandyaEuropean hematology association congressEuropean hematology associationCancer metabolism global development oncology immunoYork heart associationCancer metabolism global development oncologyNew york heart associationHematology associationHematology association congressPatients with idh1 mutatedElapsed refractory myelodysplastic syndrome

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