FDA Agrees to Special Protocol Assessment (SPA) to Evaluate the Safety and Efficacy of a Fixed-Dose Combination (FDC) of Netupitant and Palonosetron in the Prevention of CINV
Lugano, Switzerland/Woodcliff Lake, NJ (ots) - Helsinn Group and Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has agreed to the safety and efficacy protocols for Phase III trials with an investigational oral fixed-dose combination of netupitant and palonosetron in the prevention ...