Latest Radiopharmaceuticals News

Radiopharm Theranostics has received FDA clearance to begin a Phase I clinical trial for RV-01, a novel radiopharmaceutical targeting the 4Ig isoform of B7-H3 in solid tumors, marking a significant step forward in cancer treatment innovation.

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.

Radiopharm Theranostics has inked a clinical supply agreement with Cyclotek to support its Phase 1 trial of RAD 402, a novel radiotherapeutic targeting prostate cancer, set to commence in Australia in late 2025.

Clarity Pharmaceuticals has partnered with SpectronRx to manufacture and distribute its lead prostate cancer diagnostic, Cu-64 SAR-bisPSMA, at commercial scale across the US. This agreement sets the stage for a seamless launch pending FDA approval.

Telix Pharmaceuticals showcased its global theranostic radiopharmaceutical portfolio, highlighting FDA approvals, clinical progress, and a robust commercial expansion plan at its 2025 Investor Day.

Clarity Pharmaceuticals reports that its Cu-SARTATE diagnostic agent significantly outperforms the current standard in detecting neuroendocrine tumours, paving the way for a pivotal Phase III study.

Radiopharm Theranostics has initiated dosing in its Phase 1 HEAT trial of 177Lu-RAD202, a novel radiotherapeutic aimed at advanced HER2-positive solid tumors, marking a key step in its clinical development.

Radiopharm Theranostics has unveiled encouraging preclinical results for its Lu177-B7H3 monoclonal antibody, RV01, paving the way for a mid-2025 Investigational New Drug submission and a Phase 1 trial later that year.

Clarity Pharmaceuticals has successfully imaged the first patient in its pivotal Phase III AMPLIFY trial for Cu-SAR-bisPSMA, a next-generation diagnostic agent targeting recurrent prostate cancer. This milestone sets the stage for potential FDA approval and broader clinical adoption.

4DMedical has submitted its CT:VQ lung imaging technology for FDA clearance, aiming to disrupt the $1 billion US nuclear lung scan market with a non-nuclear, lower-cost alternative. Clinical studies show CT:VQ matches or exceeds existing nuclear imaging in accuracy and patient experience.

ITM Isotope Technologies Munich SE and Radiopharm Theranostics have entered a strategic supply agreement for the critical radioisotope Lutetium-177, underpinning Radiopharm’s clinical development of targeted cancer therapies.