Latest Cancer Imaging News

Imagion Biosystems has received encouraging feedback from the FDA on its MagSense HER2 breast cancer imaging program, clearing the path for a Phase 2 clinical trial and fast-tracking manufacturing.

Imagion Biosystems has received encouraging feedback from the FDA on its planned Phase 2 HER2 breast cancer clinical trial, paving the way for its Investigational New Drug application submission later this year.

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.

Optiscan Imaging Ltd has commenced a landmark clinical study at Royal Melbourne Hospital, testing its cutting-edge InVue® and InForm™ devices to improve breast cancer surgery precision. The study aims to generate critical data for US FDA approval and could redefine surgical oncology workflows.

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.

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.

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.

Imagion Biosystems has progressed its MagSense HER2 breast cancer imaging agent towards a pivotal Investigational New Drug application with the FDA, backed by a solid funding runway exceeding 13 quarters.

Telix Pharmaceuticals has gained UK MHRA approval for Illuccix, its advanced prostate cancer PET imaging agent, promising to alleviate supply shortages and improve diagnostic accuracy across the UK.

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.

Imagion Biosystems has secured a AU$3 million capital injection and resumed its collaboration with Siemens, setting the stage to prioritize FDA filings and advance its MagSense® HER2 breast cancer imaging program.

Clarity Pharmaceuticals will present compelling data on its 64Cu-SAR-bisPSMA diagnostic agent at two leading oncology conferences, highlighting earlier and more accurate prostate cancer lesion detection than current standards.