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FDA clearance

  • CDMOs & Manufacturing,Cell & Gene Therapy,Clinical Development,Clinical Trials,Regulatory Affairs

    FDA clears IND amendment for automated manufacturing of Cabaletta’s rese-cel using Cellares platforms

    Cellares has secured FDA clearance of an IND amendment allowing [...]

    January 13, 2026
  • Clinical studies,Clinical Trials,Drug approval,Medical devices,Patient Centricity,Pharmaceuticals and therapeutics,Regulatory Affairs

    Amber Implants secures FDA clearance for VCFix spinal system

    Amber Implants has received FDA 510(k) clearance for its VCFix [...]

    September 22, 2025
  • Clinical Trials,Drug Development,Pharmaceuticals and therapeutics,Precision medicine,Research & Development

    FoRx Therapeutics starts first-in-human trial of novel PARG inhibitor FORX-428 in advanced solid tumors

    FoRx Therapeutics has initiated a first-in-human clinical trial of FORX-428, [...]

    August 11, 2025
  • Uncategorised

    FDA clears Daxor’s next-generation blood volume analyzer for precise fluid management

    Daxor Corporation, a global leader in blood volume measurement technology, [...]

    August 8, 2025
  • Artificial Intelligence,Clinical Development,Global health,Medical devices,Partnerships & Funding

    Magentiq Eye secures Series A funding to advance AI-powered colonoscopy solutions

    Investment led by aMoon will support US and EU commercialisation [...]

    August 1, 2025
  • Cell & Gene Therapy,Rare Diseases,Regulatory Affairs

    AAVB-039 Gains FDA clearance to advance treatment for Stargardt Disease

    AAVantgarde’s AAVB-039 gene therapy, targeting the root cause of Stargardt [...]

    July 17, 2025
  • Artificial Intelligence,Patient Centricity,Technology and platforms

    Rapid ED diagnostic linked to 39% drop in sepsis mortality, real-world study finds

    IntelliSep test from Cytovale shows potential to reshape emergency triage [...]

    July 1, 2025
  • Artificial Intelligence,Patient Centricity,Regulatory Affairs

    Viz.ai gains FDA clearance for AI tool measuring subdural hemorrhage volume

    First-of-its-kind software aims to improve treatment decisions for patients with [...]

    July 1, 2025
  • Clinical Trials,Partnerships & Funding,Regulatory Affairs

    Genetically engineered pig liver enters first-in-human trial for patients with no transplant option

    OrganOx and eGenesis launch human trial of a genetically modified [...]

    June 2, 2025

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