In a move advertised as being in line with FDA’s goal of “radical transparency,” the agency July 10 announced the publication of more than 200 complete response letters.
FDA granted accelerated approval for Modeyso (dordaviprone) for the treatment of adult and pediatric patients (1 year of age and older) with diffuse midline glioma harboring an H3 K27M mutation with progressive disease following prior therapy.
