Telix Pharmaceuticals Granted FDA Fast Track Designation for BiPASS Prostate Cancer Imaging Program

Telix Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its BiPASS® program. This program evaluates 68Ga-PSMA-PET imaging alongside MRI for detecting prostate cancer prior to biopsy, aiming to address an unmet need by enabling an imaging-first approach to initial diagnosis. The Fast Track designation facilitates more frequent engagement with the FDA and may expedite the review of the planned New Drug Application (NDA).