Telix cancer imaging agent granted FDA review (TLX:NASDAQ)

Telix cancer imaging agent granted FDA review (TLX:NASDAQ)

Telix Pharmaceuticals (TLX) stock in focus as company secures FDA priority review for TLX250-CDx, a PET imaging agent for kidney cancer diagnosis. Read more here.

FDA Grants Priority Review to TLX250-CDx in Clear Cell RCC Imaging

Data from the phase 3 ZIRCON study support the biologics license application for TLX250-CDx in clear cell renal cell carcinoma imaging.

FDA grants priority review to 89Zr-DFO-girentuximab for kidney cancer imaging

The PDUFA date is August 27, 2025.

FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review - Pipelinereview

MELBOURNE, Australia I February 26, 2025 I Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) 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[1] imaging agent TLX250-CDx  (Zircaix®[2], 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA[3] date of 27 August 2025, pa…

FDA Accepts BLA for TLX250-CDx (Zircaix®) for Kidney Cancer Imaging, Grants Priority Review

Melbourne (Australia) | 26 February 2025 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[1] imaging agent TLX250-CDx  (Zircaix®[2], 89Zr-DFO-girentuximab), granted a Priority Review and provided a PDUFA[3] date of 27 August 2025, paving the way for a U.S. commercial launch in 2025. If approved, TLX2…