Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px has been accepted for FDA review, with a scheduled PDUFA date of Sept. 11, 2026. The radiolabeled glioma imaging agent (Pixclara; 18F-floretyrosine, 18F-FET) is intended to characterize progressive or recurrent glioma in both adults and pediatric patients. The acceptance moves the program into a clearer regulatory timeline after the earlier resubmission cycle.