Skip to content Skip to footer

Jazz Pharmaceuticals Reports the US FDA’s Approval of Modeyso (dordaviprone) for Recurrent H3 K27M-mutant Diffuse Midline Glioma 

Shots: The FDA has granted accelerated approval for Jazz Pharmaceuticals’ Modeyso (dordaviprone) to treat diffuse midline glioma with an H3 K27M mutation in pts (aged≥ 1 yrs.) with progressive disease after prior therapy. Continued approval depends on results from the P-III (ACTION) trial Approval was based on data from 50 pts across 5 studies, showing…

Read more

Chimerix Reports the Dordaviprone’s NDA Submission to the US FDA for Recurrent H3 K27M-Mutant Diffuse Glioma

Shots:Chimerix has submitted the NDA of dordaviprone (small molecule imipridone targeting the mitochondrial protease ClpP & dopamine receptor D2) to the US FDA, seeking accelerated approval for treating recurrent H3 K27M-mutant diffuse glioma Chimerix has also requested priority review along with a Rare Paediatric Disease PRV as a part of submission, as the…

Read more