CHMP Adopts Positive Opinion Recommending Approval of Bristol Myers Squibb's Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patient...
Bristol-Myers Squibb Company (BMY)
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Source: Yahoo! Fin
benefit versus standard-of-care chemotherapy alone in cisplatin-eligible adults with unresectable or metastatic urothelial carcinoma If approved, the Opdivo -based regimen would be the first immunotherapy-chemotherapy combination approved for this patient population in the EU A decision on the EU marketing authorization is expected by June 2024 PRINCETON, N.J., April 26, 2024 BUSINESS WIRE Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Opdivo ® (nivolumab) in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP recommendation. The final EC decision is expected in June 2024. "For eligible patients with unresectable or metastatic uro
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News
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- U.S. Food and Drug Administration Accepts Bristol Myers Squibb's Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase) [Yahoo! Finance]Yahoo! Finance
- 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...Business Wire
- U.S. Food and Drug Administration Accepts Bristol Myers Squibb’s Application for Subcutaneous Nivolumab (nivolumab and hyaluronidase)Business Wire
BMY
Earnings
- 4/25/24 - Miss
BMY
Sec Filings
- 5/3/24 - Form 4
- 4/25/24 - Form 10-Q
- 4/25/24 - Form 8-K
- BMY's page on the SEC website