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NDA submission

  • Clinical & Regulatory,Drug Discovery & Development,Therapeutic Areas

    PolyPid prepares D-PLEX100 NDA following Phase 3 surgical infection data

    PolyPid is preparing to submit a New Drug Application for [...]

    May 5, 2026
  • Central Nervous System,Drug Discovery & Development,Pharmaceuticals and therapeutics,Therapeutic Areas

    FDA authorises Emalex Biosciences’ Expanded Access Program for Tourette syndrome drug

    Emalex Biosciences has received FDA authorisation for an Expanded Access [...]

    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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