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Wire · operational-macro

FDA grants Fast Track to Telix's pre-biopsy PSMA-PET program

1 October 2026 · By · Wire by Fusion42

Published

1 October 2026

Topic

operational-macro

◆ Sectors

Medtech

◆ Geography

United States

◆ Source

Read at radiologybusiness.com →

◆ Verified

Fusion42 · 1 October 2026 · Fusion42 review

The FDA granted Fast Track designation to Telix Pharmaceuticals' BiPASS phase 3 program, which combines gallium-68 PSMA-PET with MRI to improve detection and targeting of prostate cancer biopsies, potentially reducing unnecessary biopsies.

This Wire brief sits within Fusion42's coverage of Medtech, and 2 sources have reported it between 30 Sep 2026 and 1 Oct 2026.

◆ ◆ The Wire takeaway

You can now count on earlier regulatory clarity and faster review timelines for prostate cancer imaging tools combining PSMA-PET and MRI. Expect quicker market access and a more competitive diagnostic space where biopsy targeting improves.

◆ Coverage

2 sources · first reported 30 Sep 2026 · latest 1 Oct 2026

◆ Related on Wire

◆ Topics

Medtechfda-fast-trackprostate-cancerpsma-petdiagnosticsmedtech