Telix Pharmaceuticals Limited announced that the United States (U.S.) Food and Drug Administration (FDA) has granted Fast Track designation1 for the Company?s investigational glioma imaging product, TLX101-CDx (Pixclara?2, 18F-floretyrosine or 18F-FET). The granted Fast Track designation is for the characterisation of progressive or recurrent glioma using positron emission tomography (PET). Concurrently, Telix is in the final stages of preparing its U.S. New Drug Application (NDA) for TLX101-CDx in this initial indication, in both adult and paediatric patients.

This designation enables expedited review and closer consultation with the FDA during the review process.