The U.S. FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), a radiolabeled glioma imaging agent used to characterize progressive or recurrent glioma across adult and pediatric patients. The agency assigned a Sept. 11, 2026 PDUFA action date. This acceptance keeps Telix’s brain-imaging program on a defined regulatory timetable after the company resubmitted its application. For radiopharmaceutical developers, review acceptance is a key gating milestone that can influence manufacturing planning and payer discussions. The decision matters for the imaging competition in neuro-oncology, where adoption depends on clinical utility evidence and the ability to integrate imaging workflows into routine care.