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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.
Telix was granted FDA Fast Track designation for its BiPASS pre—biopsy prostate cancer imaging.Material DetailsContext by AI AnalystThis is an early regulatory acceleration step that could speed development of Telix’s imaging candidate. A larger catalyst would be positive clinical data, regulatory…
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.