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BioWorld - Wednesday, July 29, 2026
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Home » FDA issues refusal to file letter for Telix imaging agent
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FDA issues refusal to file letter for Telix imaging agent

Aug. 1, 2024
By Tamra Sami
Radiopharmaceutical company Telix Pharmaceuticals Ltd. received a U.S. FDA refusal to file letter for its BLA seeking approval of renal cancer imaging agent TLX250-CDx (89Zr-DFO-girentuximab) for clear cell renal cell carcinoma (ccRCC).
BioWorld Medical technology Regulatory Cancer Protein Asia-Pacific Australia U.S. FDA

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