28 August 2024 - Telix today announces it has submitted a new drug application to the US FDA for TLX101-CDx, (Pixclara, 18F-floretyrosine or 18F-FET), an investigational PET agent for the characterisation of progressive or recurrent glioma (brain cancer) from treatment related changes in both adult and paediatric patients.

Given the potential to address significant unmet medical need, Pixclara has been granted orphan drug and fast track designation by the FDA, which facilitates expedited review and closer consultation with the agency during the review process.

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