Latest Oncology Diagnostics News

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.

Telix Pharmaceuticals reported a robust 63% year-over-year revenue increase to $204 million in Q2 2025, launched its new prostate cancer imaging agent Gozellix in the U.S., and advanced key clinical trials despite an ongoing SEC inquiry.

Telix Pharmaceuticals has achieved a key milestone with its next-generation prostate cancer imaging agent, Gozellix, receiving a permanent HCPCS code from U.S. Medicare. This paves the way for broader reimbursement and market adoption starting October 2025.

Clarity Pharmaceuticals has initiated its second registrational Phase III AMPLIFY trial for the Cu-SAR-bisPSMA PET imaging agent targeting biochemical recurrence of prostate cancer. The multi-centre study aims to generate critical data supporting FDA approval and could redefine prostate cancer diagnostics.

Radiopharm Theranostics' RAD 101 radiotracer demonstrates high sensitivity in detecting brain metastases using a novel PET-mpMRI approach, with a Phase 2b trial now recruiting in the US.

Telix Pharmaceuticals has exceeded its full-year 2024 revenue guidance, driven by strong sales of its prostate cancer diagnostic Illuccix® and strategic pipeline advancements.