The U.S. FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled imaging agent intended to characterize progressive or recurrent glioma in both adults and pediatric patients. The agency assigned a Sept. 11, 2026 PDUFA date. The acceptance follows the company’s prior resubmission process and keeps the glioma diagnostic asset on track in the regulatory pipeline. For clinicians and imaging developers, Pixclara is positioned within a competitive set of next-generation PET imaging approaches designed to improve lesion characterization and treatment planning. The PDUFA assignment signals that the FDA considers the resubmitted package sufficiently complete to begin substantive review. It also provides a clearer timeline for potential labeling decisions that can affect adoption, reimbursement discussions, and partner strategy. Telix’s progress reinforces the continued regulatory priority for precision diagnostics, particularly in neuro-oncology settings with high unmet needs.