Moderna’s mRNA flu vaccine passes FDA AdCom, review underway
Moderna's mRNA vaccine for influenza, mRNA-1010 or mFlusiva, has successfully passed a US FDA Advisory Committee meeting with unanimous votes in favor of its benefits outweighing risks for adults aged 50 and older. Shares of Moderna rose following the decision, which is seen as a de-risking event ahead of the August 5, 2026 PDUFA goal date. This positive outcome follows earlier regulatory hurdles for Moderna's mRNA products, including a previous FDA refusal to accept the application and funding cuts for mRNA vaccine research.
https://finance.yahoo.com/healthcare/articles/moderna-mrna-flu-vaccine-set-114325169.html