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.
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