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FDA

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

    Celon Pharma receives FDA clearance for Phase 3 trial of CPL’36 in schizophrenia

    Celon Pharma S.A. has received FDA clearance to advance its [...]

    May 5, 2026
  • Clinical & Regulatory,Manufacturing & Supply Chain,Pharmaceuticals and therapeutics

    Symbiosis expands quality leadership with new qualified person appointment

    Symbiosis Pharmaceutical Services has appointed Wendy Cook as a qualified [...]

    May 5, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Therapeutic Areas

    FDA and Telix agree resubmission plan for Pixclara glioma imaging agent

    Telix Pharmaceuticals has reached agreement with the US Food and [...]

    May 5, 2026
  • Clinical & Regulatory,Digital & Data

    Clinical trials: TransCelerate and FDA explore pragmatic trial designs to broaden patient access

    TransCelerate BioPharma and the US Food and Drug Administration (FDA) [...]

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

    Symbiosis completes 1,000th batch of sterile injectable drug product

    Contract manufacturer Symbiosis Pharmaceutical Services has announced the completion of [...]

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

    FDA’s phase-out of mandatory animal testing: Certara’s Patrick Smith on biosimulation and the future of drug development

    The US Food and Drug Administration’s (FDA) decision to phase [...]

    May 5, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Therapeutic Areas

    Cidara’s long-acting antiviral shows promise in Phase 2b flu prevention trial

    Cidara Therapeutics’ investigational long-acting antiviral, CD388, has achieved statistically significant [...]

    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,Digital & Data

    FDA shifts drug testing paradigm with plan to replace animal studies in monoclonal antibody development

    Regulators back AI and organ-on-a-chip technologies to modernize safety evaluation [...]

    May 5, 2026
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