Blue Earth wins FDA nod for PSMA-PET tracer NDA

By AuntMinnie.com staff writers

September 27, 2022 -- The U.S. Food and Drug Administration (FDA) has accepted a new drug application (NDA) from Blue Earth Diagnostics for its investigational radiohybrid prostate-specific membrane antigen (PSMA) F-18 rhPSMA-7.3 radiopharmaceutical.

F18 rhPSMA PET image showing prostate cancer spread beyond the prostate region
F-18 rhPSMA-7.3 PET image showing prostate cancer spread beyond the prostate region. Photo courtesy of Blue Earth Diagnostics.

Blue Earth submitted the NDA for the use of F-18 rhPSMA-7.3 in PET imaging of prostate cancer, according to the vendor. The submission was supported by clinical data from one prospective phase I study and two prospective phase III clinical trials, Blue Earth said.


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