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Telix Pharmaceuticals

Biotech companyAI in AustraliaAI. FDA records under 2 spellings of its name, each linked to the record.

  • Drug applications: 2
  • Complete response letters: 2

Records by Year

Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date

Latest Records

Newest first across sources; each opens the record
DateRecordSource
Apr 10, 2026Complete response letter, BLA 761401UnapprovedComplete response letters
Apr 25, 2025Complete response letter, NDA 218592UnapprovedComplete response letters

Names and Identifiers

Appears as
TELIXTelix Pharmaceuticals (US) Inc.

Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.