FDA Grants Fast Track Designation to Telix's BiPASS Program for Pre-Biopsy Prostate Cancer Imaging

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Telix Pharmaceuticals' BiPASS program. This program is evaluating gallium-68 PSMA-PET imaging in combination with MRI for the detection of prostate cancer prior to biopsy, aiming to improve diagnostic accuracy and potentially reduce unnecessary invasive procedures.