27 November 2015 - Bristol-Myers Squibb today announced that the U.S. FDA has issued a Complete Response Letter for its supplemental Biologics License Application for Opdivo (nivolumab) as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.

For more details, go to: http://news.bms.com/press-release/bristol-myers-squibb-announces-regulatory-update-opdivo-nivolumab-advanced-melanoma