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Telix gains FDA Fast Track status for pre-biopsy prostate imaging
8:20am on Wednesday 30th of September, 2026 AEST
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Pharmaceuticals and Biotechnology
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Telix gains FDA Fast Track status for pre-biopsy prostate imaging
8:20am on Wednesday 30th of September, 2026 AEST
Key Points
FDA Fast Track designation for the BiPASS program
Phase 3 enrolment completed and NDA pathway planned
68Ga-PSMA-PET and MRI assessed before prostate biopsy
Pre-biopsy use of Illuccix and Gozellix remains unapproved
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Telix Pharmaceuticals (ASX:TLX)
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