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FDA Breakthrough Therapy designation

  • Biotech,Clinical Trials,FDA,Hematology,Rare Diseases,Regulatory Affairs

    Hemab Therapeutics wins FDA breakthrough therapy status for sutacimig in Glanzmann thrombasthenia

      The FDA has granted breakthrough therapy designation to Hemab [...]

    March 5, 2026
  • Clinical Trials,Oncology,Rare Diseases,Regulatory Affairs

    Protagonist Therapeutics gains FDA Breakthrough Therapy designation for rusfertide in polycythemia vera

    Protagonist Therapeutics has announced that the US Food and Drug [...]

    August 27, 2025

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