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fast track designation

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

    Polaryx advances Phase 2 trial of PLX-200 in four rare diseases

    Polaryx Therapeutics is preparing to start its Phase 2 SOTERIA [...]

    August 26, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Research & Development,Therapeutic Areas

    FDA grants Fast Track designation to Erasca pancreatic cancer drug

    The FDA has granted Fast Track designation to Erasca’s investigational [...]

    August 24, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Therapeutic Areas

    Aravax’s PVX108 wins FDA Fast Track designation for peanut allergy

    Aravax’s PVX108 has received FDA Fast Track designation as the [...]

    August 3, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Research & Development

    HAYA Therapeutics wins FDA Fast Track designation for HTX-001 in heart disease

    HAYA Therapeutics has received FDA Fast Track designation for HTX-001, [...]

    July 29, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Therapeutic Areas

    FDA grants Fast Track status to SOTIO’s colorectal cancer ADC ahead of Phase 1/2 trial

    The US FDA has granted Fast Track Designation to SOTIO [...]

    July 14, 2026
  • Clinical & Regulatory,Therapeutic Areas

    Rare Disease Day 2026: Cereno Scientific advances disease-modifying therapies in PAH

    As Rare Disease Day 2026 shines a spotlight on patients [...]

    May 5, 2026
  • Central Nervous System,Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics

    Alto Neuroscience completes Phase 2 enrollment for ALTO-101 in cognitive impairment associated with schizophrenia

    Alto Neuroscience has completed patient enrollment in its Phase 2 [...]

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Therapeutic Areas

    Cidara Therapeutics receives FDA Breakthrough Therapy designation for CD388 in seasonal influenza prevention

    Cidara Therapeutics has received Breakthrough Therapy designation from the US [...]

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory

    Nanoscope Therapeutics begins FDA submission for gene-agnostic therapy to treat retinitis pigmentosa

    Nanoscope Therapeutics has initiated a rolling submission for its Biologics [...]

    May 5, 2026
  • Advanced Therapies,Clinical & Regulatory,Drug Discovery & Development

    Protagonist and Takeda present VERIFY data on rusfertide showing strong results in polycythemia vera

    Protagonist and Takeda have shared full 32-week results from the [...]

    May 5, 2026

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