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Phase 3 clinical trial

  • Clinical & Regulatory,Drug Delivery & Formulation,Pharmaceuticals and therapeutics,Research & Development,Therapeutic Areas

    FDA grants Priority Review to Belite Bio’s tinlarebant for Stargardt disease

    The FDA has accepted Belite Bio’s application for tinlarebant and [...]

    August 13, 2026
  • Advanced Therapies,Biotech & Pharma Business,Clinical & Regulatory,Pharmaceuticals and therapeutics,Research & Development

    CellProthera and Alfresa sign MOU for ProtheraCytes Phase 3 trial in Japan

    CellProthera and Alfresa Holdings have signed an MOU covering potential [...]

    August 13, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

    FDA approves Moderna’s mRNA flu vaccine mFLUSIVA

    The FDA has approved Moderna’s mRNA seasonal influenza vaccine mFLUSIVA [...]

    August 13, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Research & Development,Therapeutic Areas

    Vaderis raises $152M and starts Phase 3 trial of engasertib in HHT

    Vaderis Therapeutics has raised $152M and started a global Phase [...]

    August 12, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Research & Development,Therapeutic Areas

    CHMP recommends EU approval of Lynavoy for cholestatic pruritus in PBC

    The EMA’s CHMP has recommended EU approval of Lynavoy for [...]

    July 24, 2026
  • Central Nervous System,Clinical & Regulatory,Pharmaceuticals and therapeutics,Research & Development

    CHMP recommends approval of NEZGLYAL for rare neurodegenerative disease

    The EMA’s CHMP has recommended approval of NEZGLYAL for boys [...]

    July 24, 2026
  • Advanced Therapies,Clinical & Regulatory,Genomics and sequencing,Pharmaceuticals and therapeutics,Research & Development

    Atsena receives EMA orphan designation for two inherited retinal disease gene therapies

    Atsena Therapeutics has received EMA orphan designation for two gene [...]

    July 24, 2026
  • Clinical & Regulatory,Medical devices,Pharmaceuticals and therapeutics,Research & Development

    Tenpoint submits UK application for presbyopia eye drop YUVEZZI

    Tenpoint Therapeutics has submitted a Marketing Authorization Application (MAA) to [...]

    July 14, 2026
  • Advanced Therapies,Biotech & Pharma Business,Clinical & Regulatory,Drug Discovery & Development,Manufacturing & Supply Chain,Therapeutic Areas

    Hansa Biopharma’s BLA for imlifidase accepted by FDA

    Hansa Biopharma’s Biologics License Application (BLA) for imlifidase has been [...]

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory,Manufacturing & Supply Chain,Therapeutic Areas

    CellProthera acquires full rights to transendocardial catheter from Celyad Oncology

    CellProthera has acquired full rights to the transendocardial catheter originally [...]

    May 5, 2026
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