Telix gets FDA nod for gallium injection prep kit

The U.S. Food and Drug Administration (FDA) has cleared Telix Pharmaceuticals' gallium-68 (Ga-68) gozetotide injection (Illuccix) preparation kit.

To qualify for radioligand therapy, patients must be imaged with an approved gallium-based PSMA-PET agent; the Illuccix kit identifies patients who are candidates for the only FDA-approved prostate-specific membrane antigen (PSMA)-directed radioligand therapy, Pluvicto, according to the firm.