FDA grants priority review for Sanofi's dengue vaccine candidate

Sanofi

31 October 2018 - The United States FDA has accepted a biologics license application for Sanofi Pasteur's dengue vaccine.

The dengue vaccine candidate has been granted priority review by the FDA as it would represent the first and only medical prevention tool against dengue, including severe dengue, which is considered an unmet medical need. 

The FDA set a Prescription Drug User Fee Act action date of 1 May 2019.

Read Sanofi press release

Michael Wonder

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Michael Wonder

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US , Vaccine , Priority review