Telix Pharmaceuticals Wins FDA Fast Track for BiPASS Prostate Cancer Imaging

Telix Pharmaceuticals wins FDA Fast Track for BiPASS prostate cancer imaging

Telix Pharmaceuticals shares are in the spotlight after the FDA granted Fast Track for its BiPASS pre-biopsy prostate cancer imaging program.

Telix Pharmaceuticals Limited gets BiPASS Fast Track

A 350-patient Phase 3 study is testing PSMA PET with MRI before biopsy; Telix's Sept. 30 release gives no readout or NDA submission date.

Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging

This article is part of the daily news updates from FNArena.com. Stay informed with the latest financial, business, and economic insights. Written by Rudi Filapek-Vandyck FDA Fast Track designation granted for Telix’s BiPASS® program, which is evaluating 68Ga-PSMA-PET imaging alongside MRI in the pre-biopsy prostate...

Telix Granted FDA Fast Track Designation for BiPASS Pre-Biopsy Prostate Cancer Imaging - Telix Pharmaceuticals Limited

Telix today announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s BiPASS® program, evaluating gallium-68 (68Ga) PSMA-PET imaging in combination with MRI for the detection of prostate cancer prior to biopsy.