Jazz Pharmaceuticals Receives FDA Approval for Modeyso™ (dordaviprone), the First Treatment for Ultra-Rare Brain Tumor

Reuters
Aug 21
Jazz Pharmaceuticals Receives FDA Approval for Modeyso™ (dordaviprone), the First Treatment for Ultra-Rare Brain Tumor

Jazz Pharmaceuticals plc has announced that its new drug, Modeyso™ (dordaviprone), received accelerated approval from the U.S. Food and Drug Administration (FDA) on August 6, 2025. This approval is for the treatment of adult and pediatric patients aged 1 year and older with diffuse midline glioma harboring an H3 K27M mutation, specifically for those with progressive disease following prior therapy. Modeyso is notable for being the first and only FDA-approved treatment option for this ultra-rare and aggressive brain tumor. Jazz Pharmaceuticals will provide further details on clinical data and commercialization strategies during an investor webcast scheduled for August 27, 2025.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Jazz Pharmaceuticals plc published the original content used to generate this news brief via PR Newswire (Ref. ID: SF53996) on August 20, 2025, and is solely responsible for the information contained therein.

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