21st Austria weekly – Valneva (14/08/2023)

Valneva: Valneva, an Austrian/French specialty vaccine company, announced that the U.S. Food and Drug Administration (FDA) has revised the Prescription Drug User Fee Act (PDUFA) action date for the Biologics License Application (BLA) for VLA1553, 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 4 program necessary under the accelerated approval pathway. No additional clinical data have been requested for the approval process.Valneva: weekly performance: -11.29% (From the 21st Austria weekly https://www.boerse-social.com/21staustria (14/08/2023)Den vollständigen Artikel lesen …