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FDA Grants Priority Review Status to Cholera Vaccine
December 23, 2015.
FDA News reports that FDA has granted priority review status to PaxVax’s single-dose cholera vaccine Vaxchora.
The Agency has identified cholera as one of the eligible neglected tropical diseases under its priority review voucher program. The potential of being granted a voucher was a significant incentive for PaxVax to develop the vaccine for the U.S. market, the company says.
If licensed, Vaxchora would be the only vaccine against cholera approved in the U.S.
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