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Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging
The Manila Times· 2026-09-30 10:08
FDA Fast Track designation granted for Telix's BiPASS® program, which is evaluating 68Ga-PSMA-PET imaging alongside MRI in the pre-biopsy prostate cancer setting.The designation recognizes the program's potential to address an important unmet need by enabling an imaging-first approach to initial prostate cancer diagnosis.Fast Track facilitates more frequent engagement with the FDA and may enable expedited review of the planned NDA.MELBOURNE, Australia and INDIANAPOLIS, Sept. 30, 2026 /PRNewswire/ -- Telix ...