Update on US FDA BLA for Novavax’s COVID-19 vaccine

Novavax

2 April 2025 - Novavax can confirm that 1 April 2025, was the US FDA’s Prescription Drug User Fee Act date for our biologics license application (BLA) seeking the approval of our COVID-19 Vaccine. 

As of 1 April 2025 we had responded to all of the FDA’s information requests and we believe that our BLA is ready for approval.

Read Novavax press release

Michael Wonder

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Michael Wonder

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US , Vaccine , Dossier , COVID-19