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Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs

Multidisciplinary Collaborations Fuel New Glioma Treatment Breakthroughs
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FDA accepts Servier's NDA review for glioma treatment

The US Food and Drug Administration (FDA) has accepted Servier’s NDA filing and priority review for vorasidenib for IDH-mutant diffuse glioma. ....

Susan Pandya , Servier Cancer Metabolism Global Development Oncology , European Medicines Agency , European Commission , Prescription Drug User Fee Act , Cancer Metabolism Global Development Oncology ,

FDA Accepts Application, Grants Priority Review to Vorasidenib for IDH-Mutant Diffuse Glioma

If vorasidenib receives full approval, it would be a first-in-class target therapy to treat individuals with IDH-mutant gliomas. ....

Susan Pandya , Claude Bertrand , European Medicine Agency , Research Development , New Drug Application , Priority Review , Prescription Drug Unser Fee Act , Cancer Metabolism Global Development Oncology , Hazard Ratio , Confidence Interval , Executive Vice President , Chief Scientific Officer ,

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 ,

Vorasidenib Under Review for Isocitrate Dehydrogenase-Mutant Diffuse Glioma

The NDA is supported by results from the phase 3 INDIGO trial, which included patients 12 years of age and older with residual or recurrent grade 2 glioma with confirmed IDH1 or IDH2 gene mutation who had undergone surgery as their only treatment. ....

Susan Pandya , Drug Administration , Priority Review , New Drug Application , Cancer Metabolism Global Development Oncology , Prescription Drug User Fee Act ,