Moderna announces the US FDA will initiate the review of its investigational seasonal influenza vaccine submission

Moderna

18 February 2026 - Moderna has received a PDUFA goal date of 5 August 2026.

Moderna today announced that, in response to a prior refusal to file letter, the Company engaged with the US FDA in a Type A meeting and proposed a revised regulatory approach for its investigational seasonal influenza vaccine candidate, mRNA-1010.

Read Moderna press release

Michael Wonder

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Michael Wonder

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US , Regulation , Vaccine , Dossier