Tags : Selumetinib

AstraZeneca and MSD Report FDA’s Acceptance of NDA for Selumetinib

Shots: The US FDA has accepted NDA and granted Priority Review for Selumetinib as a new therapy for pediatric patients aged ≥3yrs. with neurofibromatosis type 1 (NF1) and symptomatic, inoperable plexiform neurofibromas (PNs) The NDA submission is based on SPRINT P-II Stratum 1 study evaluating Selumetinib (bid, PO) in pediatric patients with NF1 and symptomatic, […]Read More