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FDA issues CRL for Telix’s kidney cancer imaging agent

Aug. 28, 2025

Telix Pharmaceuticals Ltd. received an FDA complete response letter (CRL) a day after the Aug. 27 PDUFA date for its BLA for radiopharmaceutical renal cancer imaging agent, Zircaix (TLX250-CDx, 89Zr-DFO-girentuximab).

BioWorld Medical technology Regulatory Diagnostics Cancer Antibody Asia-Pacific Australia U.S. FDA

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