US FDA approves Jazz Pharmaceuticals’ Modeyso to treat recurrent H3 K27M-mutant diffuse midline glioma: Dublin Friday, August 8, 2025, 11:00 Hrs [IST] Jazz Pharmaceuticals plc, ...

Modeyso is the first and only approved treatment for recurrent H3 K27M-mutant diffuse midline glioma in patients aged one ...

The FDA has granted accelerated approval to Modeyso (dordaviprone) for the treatment of certain patients with diffuse midline glioma.

FDA accelerates approval of dordaviprone, the first targeted therapy for aggressive diffuse midline glioma, offering hope for ...

The US Food and Drug Administration (FDA) has given accelerated approval to Jazz Pharmaceuticals for Modeyso (dordaviprone) ...

Modeyso is the first drug to treat patients with diffuse midline glioma with an H3 K27M mutation, an ultra-rare and aggressive brain tumor.

The FDA granted accelerated approval to dordaviprone for the treatment of patients aged 1 year and older with recurrent diffuse midline glioma who harbor the H3 K27M mutation with progressive disease ...

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OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046)FDA ...

The U.S. FDA granted accelerated approval to Modeyso for the patients with diffuse midline glioma with an H3 K27M mutation ...