Telix Pharmaceuticals (TLX) announced the FDA has approved its New Drug Application for Gozellix, next-generation PSMA-PET imaging agent for prostate cancer. Gozellix, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen level. The company noted that Gozellix provides a longer shelf life of up to six hours and an extended distribution radius compared to existing gallium-based imaging products.
Kevin Richardson, CEO, Telix Precision Medicine, said, "Securing FDA approval for Gozellix is a major win for prostate cancer patients, who gain enhanced access to state-of-the-art 68Ga PSMA-PET imaging."
Shares of Telix are up 3% in pre-market trade on Friday.
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