The FDA approved Telix Pharmaceuticals’ Pixclara (floretyrosine F-18, 18F-FET), marking the first FDA-approved FET-PET imaging agent for glioma and the first US-cleared PET radiopharmaceutical specifically targeting brain cancer. The approval brings a new imaging tool intended to support clinical decision-making in patients with suspected or known glioma. Radiopharmaceutical imaging approvals are increasingly positioned as complementary to therapeutics, helping identify target biology and guide treatment planning. Telix’s approval also adds to the competitive landscape in brain imaging agents, where payer coverage and clinical workflow integration can be decisive. For biotech and med-tech developers, the clearance signals continued FDA willingness to approve targeted imaging modalities that address unmet needs in neuro-oncology.