FDA accepts Bristol-Myers Squibb's application for Opdivo (nivolumab) in patients with resected high-risk advanced melanoma and grants priority review

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) to treat patients with melanoma who are at high risk of disease recurrence following complete surgical resection. The FDA also previously granted Breakthrough Therapy Designation for this application,
Source: World Pharma News - Category: Pharmaceuticals Tags: Featured Bristol-Myers Squibb Business and Industry Source Type: news