Telix Pharmaceuticals said the U.S. FDA approved Pixclara (floretyrosine F-18, 18F-FET), positioned as the first FDA-approved FET-PET imaging agent for glioma and the first U.S.-approved PET radiopharmaceutical specifically targeting brain cancer using this mechanism. Pixclara is intended for differentiating recurrent or progressive glioma from treatment-related changes in adults and pediatric patients 1 month of age and older. The approval came after nearly 18 months from an FDA complete response letter requesting additional clinical evidence. As an imaging product, Pixclara adds a new diagnostic lever that can affect downstream trial enrollment, response assessment, and treatment decisions in neuro-oncology.