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Telix said the FDA granted Fast Track status for its BiPASS pre-biopsy prostate imaging program, with Illuccix and Gozellix approved for PET imaging of PSMA-positive prostate cancer lesions.
Fast Track was granted for BiPASS, a Phase 3 program testing 68Ga PSMA-PET with MRI before prostate biopsy; Phase 3 enrollment is complete and no results were reported.