Pdufa Date News Today

Saint-Herblain (France), August 14, 2023 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today 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...

FDA calendar is a useful tool to know PDUFA dates related to FDA Approval and FDA Panel review of New Drug Applications, which are catalysts of Biotech Stocks.

Reauthorizing the Prescription Drug User Fee Act Would Make It Easier to Participate in Clinical Trials and Allow the FDA to Continue Its Critical Mission