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Modeyso FDA Approval History

Last updated by Judith Stewart, BPharm on Aug 7, 2025.

FDA Approved: Yes (First approved August 6, 2025)
Brand name: Modeyso
Generic name: dordaviprone
Dosage form: Capsules
Company: Jazz Pharmaceuticals plc
Treatment for: Malignant Glioma

Modeyso (dordaviprone) is a protease activator used for the treatment of diffuse midline glioma.

Development timeline for Modeyso

DateArticle
Aug  6, 2025Approval FDA Grants Accelerated Approval to Modeyso (dordaviprone) for the Treatment of Recurrent H3 K27M-Mutant Diffuse Midline Glioma
Feb 18, 2025Chimerix Announces FDA Acceptance and Priority Review of New Drug Application for Dordaviprone as Treatment for Recurrent H3 K27M-Mutant Diffuse Glioma
Dec 30, 2024Chimerix Submits Dordaviprone New Drug Application for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma
Dec  9, 2024Chimerix to Submit Dordaviprone for Accelerated Approval to U.S. FDA for Patients with Recurrent H3 K27M-Mutant Diffuse Glioma Before Year-End

Further information

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