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news.Epeius Biotechnologies has announced that Rexin-G has received orphan drug designation from the FDA for the treatment of osteosarcoma.
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The FDA granted the orphan drug status based on several criteria, including the rarity, seriousness, and current lack of effective therapies for metastatic osteosarcoma, as well as the scientific and medicinal merit of Rexin-G.
The US orphan drug designation provides seven years of market exclusivity for Rexin-G, a reduction in fees and taxes, and additional regulatory support for R&D initiatives.