− Master Supply Agreement encompasses clinical development and commercial supply for Clarity’s Cu-67-based candidates to treat neuroblastoma, breast and prostate cancers, among others −BELOIT, Wis. & SYDNEY (BUSINESS WIRE) NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic
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NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radiopharmaceuticals used for medical imaging and therapeutic treatments, today announced that the U.S. Food and Drug Administration (FDA) has approved its application for producing Mo-99 from concentrated Mo-98 (cMo-98) and related software updates for the RadioGenix® System (technetium Tc 99m generator). Processing of cMo-98 targets increases production capacity of the important medical radioisotope, molybdenum-99 (Mo-99), up to four times above that of current NorthStar technology, and enables NorthStar to provide customers with higher activity source vessels, which will support enhanced radiopharmacy efficiencies. FDA approval was granted through a Prior Approval Supplement (PAS) to NorthStar’s original RadioGenix® System (technetium Tc 99m generator) New Drug Application, which was approved in 2018. The R