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Bristol Myers Squibb Receives European Commission Approval for Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma

Approval based on results from CheckMate -901, the first Phase 3 trial in this patient population with an immunotherapy-chemotherapy combination to demonstrate survival benefit versus. ....

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Bristol Myers Squibb Provides Update on Phase 3 CheckMate -73L Trial

Bristol Myers Squibb Provides Update on Phase 3 CheckMate -73L Trial
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European Medicines Agency Validates Bristol Myers Squibb's Application for Opdivo (nivolumab) Plus Yervoy (ipilimumab) for the First-Line Treatment of Adult Patients with Microsatellite...

Application based on results from the CheckMate -8HW study, in which Opdivo plus Yervoy demonstrated statistically significant and clinically meaningful improvement in progression-free survival. ....

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U.S. Food and Drug Administration Accepts Bristol Myers Squibb's Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase)

Application based on results from CheckMate -67T, the first Phase 3 trial of the subcutaneous formulation of nivolumab to evaluate and demonstrate noninferior pharmacokinetics, efficacy and. ....

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