Jazz Pharmaceuticals received accelerated approval from the U.S. FDA for Modeyso (dordaviprone) for the treatment of adult and pediatric patients 1 year and older with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the Phase 3 ACTION confirmatory trial. Modeyso is the first and only treatment option approved by the FDA for th...