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The U.S. Food and Drug Administration has approved supplemental New Drug Applications for three type 2 diabetes medicines within the empagliflozin family to include data from the landmark EMPA-REG OUTCOME® trial.
The US Food and Drug Administration (FDA) has granted priority review status for the supplemental new drug application for Stivarga (regorafenib, Bayer), as a second line systemic treatment of patients with hepatocellular carcinoma (HCC) in the US.