The FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine), a radiolabeled imaging agent for characterizing progressive or recurrent glioma in both adults and pediatric patients. The agency assigned a Sept. 11, 2026 PDUFA date. The resubmission moves Telix back into an FDA review cycle after prior communications, with the upcoming action focusing on the clinical and regulatory completeness of the data package for this PET imaging approach. Imaging approvals can shift standard-of-care in neuro-oncology by enabling more consistent patient stratification and treatment planning based on disease characterization.