Article

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.

Newsletter

Lead with insight with the Pharmaceutical Executive newsletter, featuring strategic analysis, leadership trends, and market intelligence for biopharma decision-makers.

Related Videos
Gen Li
Gen Li
Ted Sweetser
Ted Sweetser
Ted Sweetser