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BioWorld - Monday, February 9, 2026
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» 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).
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