FDA declines expanded approval for Bristol-Myers' Opdivo drug
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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.
The regulator issues a complete response letter when a new or generic treatment cannot be approved in its current form.
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.
The regulator issues a complete response letter when a new or generic treatment cannot be approved in its current form.
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