💊U.S. Food and Drug Administration (FDA) Accepts Bristol-Myers Squibb’s Application for Opdivo (nivolumab) in Patients with Resected High-Risk Advanced Melanoma and Grants Priority Review .
PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE: BMY) announced today 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, which is the seventh indication for which Opdivo has received this designation. BMS Newsroom
https://news.bms.com/press-release/corporatefinancial-news/us-food-and-drug-administration-fda-accepts-bristol-myers-squi