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ForXiga gets surprise OK in Europe despite FDA complete response letter

This article was originally published in Scrip

Executive Summary

To the surprise of some in the industry, the European Medicines Agency’s advisory body, the Committee for Medicinal Products for Human Use (CHMP), has recommended the approval of Forxiga (dapagliflozin) from Bristol-Myers Squibb and AstraZeneca as a treatment for type 2 diabetes mellitus.



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