FDA will review bid to extend label for Sprycel in chronic myeloid leukemia

12 July 2017

Bristol-Myers Squibb (NYSE: BMY) has announced that the US Food and Drug Administration will review the company’s application to broaden the label for Sprycel (dasatinib).

Bristol-Myers wants approval to market the drug as a treatment for children with a certain kind of chronic myeloid leukemia (CML), and in a new powder for oral suspension formulation.

The application is under priority review with an action date of November 9, 2017.

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