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FDA Breakthrough Therapy designation

  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

    Merck wins FDA Breakthrough Therapy designation for lupus drug enpatoran

    Merck has received FDA Breakthrough Therapy designation for enpatoran, an [...]

    July 9, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Therapeutic Areas

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

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

    May 5, 2026
  • Clinical & Regulatory,Therapeutic Areas

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

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

    May 5, 2026

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