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Sanofi's Rezurock Rejected; Wayrilz Gains Approval in Europe

10/17/2025

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Story summary
  • The European Medicines Agency's Committee for Medicinal Products for Human Use rejected Sanofi's Rezurock for chronic graft-versus-host disease due to insufficient efficacy evidence, and Sanofi plans a re-examination.
  • The CHMP recommended Wayrilz for immune thrombocytopenia based on the LUNA 3 phase 3 results.
  • Rezurock is approved in 20 countries, including the United States and Canada, and has been prescribed to over 17,000 patients since its initial approval.