PDUFA date extension for VLA 1553, chikungunya virus vaccine candidate
Valneva SE a specialty vaccine company, announced that the FDA has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA 1553, Valneva’s chikungunya virus vaccine candidate, from the previously communicated end of August to the end of November
The FDA extended the PDUFA date to allow sufficient time to align and agree on the phase IV program necessary under the accelerated approval pathway. No additional clinical data have been requested for the approval process.
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