# TLX PDUFA Calendar: FDA Decision Dates & Catalyst Timeline

Canonical URL: https://biopharmsignal.com/pdufa-calendar/TLX
Company: Telix Pharmaceuticals Ltd

BioPharmSignal tracks active PDUFA and FDA decision milestones associated with TLX.

## TLX PDUFA Milestones

- 2025-03-20 — FDA Approval — FDA approved application. FDA recorded approval of GOZELLIX on March 20, 2025. This list-only historical record is sourced from the official FDA application...
  Company: Telix Pharmaceuticals Ltd
  Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219592
  Event detail: https://biopharmsignal.com/pdufa-calendar/TLX/gozellix-nda-219592-orig-1.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/march (March 2025)
- 2025-04-28 — CRL — FDA issued Complete Response Letter. The sponsor reported that FDA issued a Complete Response Letter for PIXCLARA / TLX101 (floretyrosine F 18) on April 28,...
  Company: Telix Pharmaceuticals Ltd
  Source: https://www.sec.gov/Archives/edgar/data/2007191/000200719125000049/pixpr.htm
  Event detail: https://biopharmsignal.com/pdufa-calendar/TLX/pixclara-tlx101-floretyrosine-f-18-pixclara-nda.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2025/april (April 2025)
- 2026-09-11 — PDUFA — FDA approved Pixclara for glioma PET imaging. FDA approved Pixclara for PET imaging to differentiate recurrent or progressive glioma from treatment-related c...
  Company: Telix Pharmaceuticals Ltd
  Source: https://telixpharma.com/news-views/fda-approves-telixs-brain-cancer-imaging-drug-pixclara/
  Event detail: https://biopharmsignal.com/pdufa-calendar/TLX/pixclara-floretyrosine-f18-glioma-imaging-review-2.md
  Month page: https://biopharmsignal.com/pdufa-calendar/2026/september (September 2026)

## Related Pages

- Company page: https://biopharmsignal.com/company/TLX
- Interactive PDUFA Calendar: https://biopharmsignal.com/pdufa-calendar

## FAQ

### What does the TLX PDUFA calendar show?

It shows active PDUFA and FDA decision milestones associated with TLX, including decision dates, application stage, and summary details when available.
### Where can I find more context for TLX?

Use the BioPharmSignal company page for TLX to read related news, stock data, sector context, and company-specific updates.
### Are these dates investment advice?

No. PDUFA dates are research inputs, not investment recommendations. Always review primary sources and understand the clinical and regulatory context.