Top Regulatory News Stories – Week Ending June 14, 2019

Genentech’s blood cancer drug Polivy earned an accelerated approval from the U.S. FDA due to the complete response rate shown during clinical trials.  https://www.biospace.com/article/genentech-s-blood-cancer-drug-approved-two-months-ahead-of-pdufa-date/?s=61 The FDA approved Merk’s Keytruda as a frontline treatment for head and neck cancer.  Keytruda was initially approved in 2014 for advanced melanoma and has since received approvals as treatment for[…]