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

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.