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AstraZeneca/BMS's Dapagliflozin Needs European Epidemiological Study, But Headed For Strong Label

This article was originally published in The Pink Sheet Daily

Executive Summary

Europe's CHMP takes divergent stance to FDA on dapagliflozin, clearing it for treating diabetes if AstraZeneca and Bristol-Myers Squibb conduct a post-marketing study. The committee also cleared ruxolitinib and ferumoxytol, but rejected Folotyn, for EU marketing.

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