(CercleFinance.com) – Valneva announces that the US FDA has successfully completed the admissibility review of its marketing authorization application for its single-shot chikungunya vaccine candidate.
The United States health authority considered that the dossier was sufficiently complete to allow a substantive review of the data submitted. The dossier was granted priority review status.
The FDA has set the end of August 2023 as its target date for completing the review of the authorization request. ‘The acceptance of the file for priority review does not mean that a marketing authorization will be granted’, however warns Valneva.
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