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

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

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

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

Meta: In July of 2025, the U.S. Food and Drug Administration approved various anti-cancer treatments and therapeutic ...

Replimune Group's RP1 oncolytic virus therapy faced an FDA rejection, raising concerns about the platform's viability in ...

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 ...

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, ...

Company on track to submit NDA for bitopertin in erythropoietic protoporphyria (EPP) under accelerated approval pathway in ...

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

The FDA granted accelerated approval to dordaviprone (Modeyso) as the first systemic therapy for adults and children with ...