Telix Pharmaceuticals’ radiolabeled glioma imaging agent moved forward after the FDA accepted the company’s resubmitted NDA. The agency accepted TLX101-Px—marketed as Pixclara, 18F-floretyrosine—for review to characterize progressive or recurrent glioma in both adult and pediatric patients. The FDA assigned a Sept. 11, 2026 PDUFA date, putting a regulatory clock on a program intended to support imaging-based decision-making in neuro-oncology. For imaging developers, acceptance typically signals that the submission package meets threshold review requirements and is ready for the substantive evaluation phase. The accepted NDA also reinforces the growing role of targeted PET tracers in stratifying glioma patients, including when disease status is uncertain at baseline.