Posted by Michael Wonder on 15 Sep 2023
Day One announces updated FIREFLY-1 data for tovorafenib and completion of rolling NDA submission to FDA for relapsed or progressive pediatric low-grade glioma
11 September 2023 - FDA filing decision expected by mid November.
Day One Biopharmaceuticals today announced the recently completed submission of the rolling new drug application to the US FDA for tovorafenib as a monotherapy in relapsed or progressive paediatric low-grade glioma.
