FDA advisers recommend approval of monoclonal antibody to protect newborns and young children from RSV
An FDA advisory committee voted overwhelmingly to recommend approval of a monoclonal antibody product to protect newborns and young children from RSV.
A Food and Drug Administration advisory committee voted overwhelmingly on Thursday to recommend approval of a monoclonal antibody product to protect newborns and young children from RSV.
The Antimicrobial Drugs Advisory Committee voted unanimously to recommend use of nirsevimab — which will be marketed as Beyfortus — in children in the first year of life. In a second vote, the committee voted 19 to 2 to recommend approval of the product for use in high-risk children in the second year of life.
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