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Home › FDA declines expanded approval for Bristol-Myers' Opdivo drug

 

FDA declines expanded approval for Bristol-Myers' Opdivo drug

2015-11-28 01:31:21| Biotech - Topix.net

REUTERS: Bristol-Myers Squibb Co said the U.S. Food and Drug Administration declined to approve its immuno-oncology drug, Opdivo, for its expanded use to treat an additional type of advanced skin cancer. Bristol-Myers said it received a so-called complete response letter from the health regulator, which indicated the need for additional data in the BRAF mutated patient population.

Tags: drug expanded approval fda

Category:Biotechnology and Pharmaceuticals

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