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Thursday, December 7, 2023

Ipsen, Genfit priority review for New Drug Application for liver disease thrapy

 

  • New Drug Application granted priority review with PDUFA date set for June 10, 2024

  • European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor

  • Investigational elafibranor is the first novel second-line treatment for primary biliary cholangitis (PBC) to be filed in E.U. and U.S. in nearly a decade

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