Bavarian Nordic Receives U.S. FDA Approval
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Bavarian Nordic Receives U.S. FDA Approval of Freeze-Dried Smallpox and Mpox Vaccine
https://www.bavarian-nordic.com/media/media/news.aspx?news=7094
"COPENHAGEN, Denmark, March 31, 2025 - Bavarian Nordic A/S (OMX: BAVA) today announced that the U.S. Food and Drug Administration (FDA) has approved the freeze-dried formulation of JYNNEOS
(Smallpox and Mpox Vaccine, Live, Non-replicating) for prevention of smallpox and mpox disease in adults 18 years of age and older. This approval will provide additional flexibility for stockpiling against a smallpox event or mpox outbreak.".. "Dagens FDA-godkendelse repræsenterer en betydelig milepæl i vores udvikling af denne næste generation af JYNNEOS og i vores samarbejde med den amerikanske regering om øget sundhedssikkerhed i befolkningen," udtaler Paul Chaplin, administrerende direktør i Bavarian Nordic "Som mangeårig leverandør af JYNNEOS til USA's biologiske beredskab er vi dedikerede til fortsat at støtte regeringens indsats for at beskytte deres borgere mod nuværende og fremtidige trusler mod folkesundheden."
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