{
  "id": 8942412,
  "title": "Andelyn Curator Biomanufacturing Platform Supports Fayuvi Gene Therapy Approval",
  "url": "https://urgent.news/2026/09/21/andelyn-curator-biomanufacturing-platform-supports-fayuvi-gene",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-09-21T14:55:32.000Z",
  "source": {
    "name": "GEN Biotechnology",
    "slug": "gen-biotechnology",
    "url": "https://www.genengnews.com/topics/omics/andelyn-curator-biomanufacturing-platform-supports-fayuvi-gene-therapy-approval/"
  },
  "original_language": "en",
  "account": null,
  "summary": "Andelyn Biosciences has begun manufacturing Fayuvi, an FDA-approved gene therapy for the treatment of Sanfilippo syndrome type A, at its Columbus, OH facility. The FDA recently approved the product developed by Ultragenyx Pharmaceutical for the rare, fatal lysosomal storage disease MPS IIIA, which primarily affects the central nervous system and is marked by rapid neurodegeneration beginning in early childhood. Fayuvi is the first FDA-approved gene therapy manufactured using Andelyn's AAV Curator Platform process, which utilizes a configurable, data-informed approach to AAV process development and manufacturing. The company's CEO, Wade Macedone, expressed congratulations on this significant achievement and recognition of the MPS IIIA community, investigators, and everyone who contributed to advancing this program.",
  "key_points": [],
  "editors_take": null,
  "illustration": null,
  "coverage": {
    "outlets": 1,
    "also_reported_by": []
  },
  "ai_generated": true,
  "disclaimer": "Summaries, key points and the editor’s take are written by software from other outlets’ reporting and may contain errors — always check the linked original."
}