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www.fdanews.com/articles/211996-blue-earths-radiohyrid-pet-imaging-agent-for-prostate-cancer-gets-fda-approval

Blue Earth’s Radiohyrid PET Imaging Agent for Prostate Cancer Gets FDA Approval

May 31, 2023

Blue Earth Diagnostics has received FDA approval of its radiohybrid imaging agent Posluma for positron emission tomography of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer with suspected metastasis who are candidates for initial definitive therapy or with suspected recurrence.

Posluma is the first and only FDA-approved PSMA targeted radiohybrid imaging agent, the company said, “developed to assist physicians in the detection and localization of prostate cancer.”

The agent includes a molecule that binds to cells that express PSMA as well as the radioisotope fluorine-18 which enables PET imaging of the prostate and other areas of the body where the cancer may have spread.

The company says it will begin distribution in early June.

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