U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Supplemental Biologics License Application for Opdivo® Plus Yervoy® for Patients with Unresectable or Metastatic Microsatellite Instability-High or Mismatch Repair Deficient…
Application based on analyses from the Phase 3 CheckMate -8HW clinical trial, in which Opdivo plus Yervoy demonstrated superior progression-free survival compared to Opdivo monotherapy and investigator’s choice of chemotherapy The U.S. Food and Drug Administration assigned a target action date of June 23, 2025 PRINCETON, N.J.–(BUSINESS WIRE)–$BMY #CRC— U.S. Food and Drug Administration Accepts … [Read more…]