Beefed-Up Submission Delays Opdivo's 1st-Line Melanoma Timeline
This article was originally published in Scrip
The FDA said it needed more time to review Bristol-Myers Squibb's supplemental biologics license application (sBLA) for its programmed death-1 immune checkpoint inhibitor Opdivo (nivolumab) as a first-line monotherapy for advanced melanoma after the company decided to beef up its submission with additional data.
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