News & Views

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 2025.

Telix today announces new Director appointments as part of a Board succession planning and renewal process.

Telix announces that the Biogenix Molecular Research Center in Miami, FL, is recruiting and dosing patients in the ProstACT Global Phase 3 trial of TLX591 for patients with advanced prostate cancer, as part of a wider United States (U.S.) roll-out. 

Telix today announces that its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by ALMPS for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Luxembourg to offer PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical.

Telix today announces that its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by MMA for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval enables healthcare providers in Malta to offer PSMA-PET imaging using a clinically validated gallium-based radiopharmaceutical.

Telix today announces that its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been granted marketing authorization by NOMA for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label.

Telix today announces its financial results for the year ended 31 December 2024.

Telix today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection).

Telix today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection).

Telix today announces that its prostate cancer PET imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection) has been approved by the Danish Medicines Agency (Lægemiddelstyrelsen).