{
  "id": 7281600,
  "title": "FDA approves Telix brain cancer imaging drug Pixclara",
  "url": "https://urgent.news/2026/09/14/fda-approves-telix-brain-cancer-imaging-drug-pixclara-7281600",
  "topic": "health",
  "section": "Health & Medicine",
  "published": "2026-09-14T08:32:12.000Z",
  "source": {
    "name": "Vietnam Investment Review",
    "slug": "vietnam-investment-review",
    "url": "https://vir.com.vn/fda-approves-telix-brain-cancer-imaging-drug-pixclara-160716.html"
  },
  "original_language": "en",
  "account": "Melbourne, Australia and Indianapolis, September 14, 2026 - The U.S. Food and Drug Administration (FDA) has granted approval for Telix Pharmaceuticals Limited's New Drug Application (NDA) for Pixclara®, an amino acid positron emission tomography (PET) drug designed for imaging gliomas, also known as brain cancer. This radioactive diagnostic drug, when combined with positron emission tomography (PET) scans, aids in distinguishing recurrent or progressive glioma from treatment-related changes in both adult and pediatric patients aged one month and above.\n\nInternational clinical practice guidelines recommend PET imaging using floretyrosine F 18 (FET-PET), with the FDA's approval of Pixclara filling a significant gap in the U.S. as no such product was previously available domestically. Gliomas constitute about 30% of all central nervous system (CNS) cancers, accounting for 80% of malignant brain tumors, and approximately 24,000 new cases are diagnosed annually in the U.S.\n\nKevin Richardson, CEO of Telix Precision Medicine, expressed that the FDA approval will broaden access to FET-PET imaging in the U.S., providing clinicians with increased confidence in diagnosis and treatment planning. Kelly Sitkin, President and CEO of the American Brain Tumor Association, emphasized that the approval will enhance glioma care through more precise monitoring, complementing MRI. Patrick Wen, MD, and co-chair of the E. Antonio Chiocca, MD, PhD, Family Endowed Chair in Neuro-Oncology at Mass General Brigham Cancer Institute, highlighted the positive impact this FDA approval will have on glioma management.",
  "summary": "The US Food and Drug Administration approved Telix Pharmaceuticals New Drug Application for Pixclara to advance imaging procedures in adult and paediatric brain cancer patients",
  "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."
}