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FDA Approves Supplemental New Drug Applications to Include New Data in Product Labels for Synjardy®,
January 06, 2017The 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. -
FDA grants priority review for Bayer’s liver cancer treatment
January 05, 2017The 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.
Pharma Sources Insight January 2025
