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.
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.
![A 53-year-old patient (patient number four) with a recurrent pituitary adenoma with extension of a cystic component of disease to the medial temporal lobe apparent on MRI (contoured in blue), and extension of disease to the left sphenoid bone and orbital apex apparent on [68Ga]Ga-DOTA-TATE (contoured in yellow).](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/04/pituitary-tumor.QGsEnyB4bU.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
