The FDA accepted for review Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine), a radiolabeled imaging agent intended to characterize progressive or recurrent glioma in adults and pediatric patients. The agency assigned a Sept. 11, 2026 PDUFA date, moving the program into a defined review timeline. Telix has submitted the application after a resubmission, indicating prior FDA questions were resolved well enough to clear acceptance. For imaging-drug developers, acceptance typically signals the core Chemistry, Manufacturing and Controls (CMC) and clinical data package are now considered reviewable. If approved, TLX101-Px would join the growing neuro-oncology imaging category where PET agents are used to guide treatment decisions, patient selection, and potentially response assessment. The timeline also affects partner and hospital adoption planning tied to reimbursement and workflow readiness. The near-term impact is scheduling certainty for Telix and additional clarity for clinicians evaluating imaging options in recurrent glioma care pathways.