AstraZeneca today announced its Biologics License Application (BLA) for nirsevimab (Beyfortus®) had been accepted for review by the U.S. Food and Drug Administration (FDA) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTI) in newborns and infants entering or during their first RSV season.
And the BLA is for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
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