FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review
Telix today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its breakthrough investigational kidney cancer PET imaging agent TLX250-CDx (Zircaix®, 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA date of 27 August 2025, paving the way for a U.S. commercial launch in...
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