Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging
The Manila Times·2026-09-30 10:08
/PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, "Telix") today announces that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation for the Company's BiPASS® program. BiPASS (Biopsy of the Prostate Avoidance Stratification Study[1]) is evaluating gallium-68 (68Ga) PSMA-PET imaging[2] in combination with MRI[3] for the detection of prostate cancer prior to biopsy. MELBOURNE, Australia and INDIANAPOLIS, Sept. 30, 2026 /PRNewswire/ -- Telix Pharmac ...