The U.S. FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled glioma imaging agent intended to characterize progressive or recurrent glioma in adults and pediatric patients. The agency assigned a Sept. 11, 2026 PDUFA date for review. TLX101-Px is designed as a diagnostic radiopharmaceutical program, meaning the regulatory path hinges on the clinical imaging performance and supporting chemistry, manufacturing, and controls for safe production and reliable signal generation. For companies developing theranostic and imaging assets, FDA acceptance is a gating milestone that allows the submission to move into formal review rather than staying in back-and-forth cycles. The acceptance also keeps pressure on timelines for imaging-driven oncology decision-making, where earlier identification of disease state can influence downstream treatment selection and trial enrollment.