Tags : Koselugo

Pharma Regulatory

AstraZeneca and MSD’s Koselugo (selumetinib) Receives the US FDA’s Approval

Shots: The approval is based on P-I/II SPRINT study assessing Koselugo (bid) as monothx. in pediatric patients aged ≥2yrs. with NF1-related inoperable PNs. The trial was sponsored by NCI CTEP, conducted under a research and development agreement between NCI and AstraZeneca with additional support from NTAP The P-I/II SPRINT study results demonstrated 66% ORR in […]Read More