U.S. Food and Drug Administration Approves Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a Treatment for Patients with Previously Untreated Microsatellite Instability-High or Mismatch R...
Bristol-Myers Squibb Company (BMY)
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Source: Business Wire
Based on the Phase 3 CheckMate-8HW trial, Opdivo plus Yervoy demonstrated reduction in the risk of disease progression or death by 79% vs. chemotherapy in the first-line setting and by 38% vs. Opdivo monotherapy across all lines of therapy 1The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a first-line treatment of adult and pediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC).1 This approval is based on the CheckMate-8HW trial, which is the largest Phase 3 trial (n=839) of immunotherapy in patients with MSI-H/dMMR mCRC, evaluating Opdivo plus Yervoy (n=354) vs. Opdivo monotherapy (n=353) in the all-lines setting and Opdivo plus
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News
- Syremis Therapeutics Launches with $165M to Develop Best-in-Class Medicines for Mental Health Conditions [Yahoo! Finance]Yahoo! Finance
- Bristol Myers Squibb to Report Results for Fourth Quarter 2025 on February 5, 2026Business Wire
- Orum, a biotech marrying ADCs with protein degraders, captures $100M in funding [Yahoo! Finance]Yahoo! Finance
- Bristol Myers Squibb Canada Welcomes Positive CDA Recommendation for OPDIVO® Plus YERVOY® as First-Line Treatment for MSI-H/dMMR Metastatic Colorectal Cancer [Globe and Mail, The (Toronto, Canada)]Globe and Mail, The
- Advancium Health Network Names Michele Cleary CEO to Drive Next Phase of Pediatric Healthcare Innovation [Yahoo! Finance]Yahoo! Finance
BMY
Earnings
- 10/31/25 - Beat
BMY
Sec Filings
- 11/18/25 - Form 8-K
- 11/12/25 - Form CERT
- 11/10/25 - Form 8-A12B
- BMY's page on the SEC website