U.S. FDA Office of Orphan Products Development

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Also known as: US FDA Office of Orphan Products Development

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NanoViricides Files Rare Pediatric Disease and Orphan Drug Applications for NV-387 Against Measles and MPox

NanoViricides has filed regulatory applications for its antiviral candidate NV-387, seeking both Rare Pediatric Disease Drug Designation for measles treatment and Orphan Drug Designation for both measles and MPox treatments. The company could qualify for significant incentives including tax credits, fee exemptions, market exclusivity, and potentially a Priority Review Voucher worth approximately $160 million. There are currently no approved drugs for treating either measles or MPox, with both diseases showing concerning case trends.