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U.S. FDA Approves Blue Earth Diagnostics’ POSLUMA (Flotufolastat F 18) Injection, First Radiohybrid PSMA-targeted PET Imaging Agent for Prostate Cancer

Imaging Technology

milla1cf Tue, 05/30/2023 - 19:49 May 30, 2023 — Blue Earth Diagnostics , a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals , today announced U.S. Results demonstrated high detection rates (% positive PET scans) even at low PSA levels.

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The rise of theranostics: Part 1 -- Gaining momentum

AuntMinnie

Theranostics pairs diagnostic biomarkers that can be visualized on nuclear medicine imaging with therapeutic agents that share a specific target in diseased cells or tissues. Lutathera was approved for adults by the FDA in 2018 after the therapy resulted in progression-free survival (median overall survival of 11.7

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The rise of theranostics: Part 1 -- Gaining momentum

AuntMinnie

Theranostics pairs diagnostic biomarkers that can be visualized on nuclear medicine imaging with therapeutic agents that share a specific target in diseased cells or tissues. Lutathera was approved for adults by the FDA in 2018 after the therapy resulted in progression-free survival (median overall survival of 11.7

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Blue Earth Diagnostics Announces Additional Results from Phase 3 SPOTLIGHT Trial of Investigational PET Imaging Agent 18F-rhPSMA-7.3 in Biochemical Recurrence of Prostate Cancer

Imaging Technology

is an investigational high affinity radiohybrid (rh) Prostate-Specific Membrane Antigen-targeted PET imaging agent. The utility of conventional imaging for the localization of recurrence is limited, and relapse after curative-intent radiation therapy remains a considerable clinical burden. 18F-rhPSMA-7.3 Gauden , D.Phil.,