Telix Pharmaceuticals won U.S. FDA approval for Pixclara (floretyrosine F-18, 18F-FET), marking the first FDA-approved FET-PET imaging agent for glioma. The approval also makes Pixclara the first U.S. PET radiopharmaceutical specifically targeting brain cancer with the FET mechanism. Pixclara is indicated to differentiate recurrent or progressive glioma from treatment-related changes in adults and pediatric patients 1 month and older. The decision comes after nearly 18 months from a prior complete response letter, during which the agency requested additional clinical evidence. For neuro-oncology programs, the approval provides a new diagnostic tool that may influence imaging strategies during follow-up and could improve patient stratification when CT or MRI findings remain ambiguous.