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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 Bertrand , Susan Pandya , European Commission , Cancer Metabolism Global Development Oncology Immuno , Meeting Of The Society For Neuro , European Medicines Agency , Research Development , Marketing Authorization Application , New England Journal , Cancer Metabolism Global Development Oncology , Prescription Drug User Fee Act , Idh 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 Pandya , European Hematology Association Congress , European Hematology Association , Cancer Metabolism Global Development Oncology Immuno , York Heart Association , Cancer Metabolism Global Development Oncology , New York Heart Association , Hematology Association , Hematology Association Congress , Patients With Idh1 Mutated , Elapsed Refractory Myelodysplastic Syndrome ,