The FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled glioma imaging agent using 18F-floretyrosine (18F-FET). The agency assigned a Sept. 11, 2026 PDUFA date, moving the program forward for characterizing progressive or recurrent glioma in both adult and pediatric settings. The acceptance follows resubmission, indicating that FDA reviewers have determined the filing is sufficiently complete for evaluation. For clinicians, the focus is on improving imaging precision in neuro-oncology to better guide treatment decisions. The timeline also helps frame competitive positioning for advanced PET/SPECT alternatives as radiopharmaceutical portfolios expand beyond diagnosis toward decision support in oncology care.