SHINE files with FDA for cancer treatment radiopharmaceutical

SHINE Technologies, a next-generation nuclear technology company, announced it has submitted a Drug Master File with the U.S. Food and Drug Administration (FDA) for non-carrier-added lutetium-177 (Lu-177) chloride, a radiopharmaceutical used for precision cancer treatment. The DMF submission provides confidential detailed information about facilities, procedures, or articles used in the manufacturing, processing, and storing of drugs. Lu-177, a cancer-killing radioisotope, is paired with a cancer-seeking molecule to form a smart compound that directly targets and attacks cancer cells. With its proprietary technology, SHINE intends to be the industry’s only vertically integrated producer of Lu-177, providing a reliable and scalable supply without the need for aging nuclear reactors.