he US Food and Drug Administration has accepted a biologics license application for a long-acting antibody for the prevention of lower respiratory tract infections caused by the respiratory syncytial virus, according to the developers of the antibody. If approved, it could be available for use in some infants and toddlers later this year.
The pharmaceutical companies AstraZeneca and Sanofi, which developed the therapy nirsevimab, announced Thursday that the FDA “has indicated it will work to expedite its review” and could take action in the third quarter of this year.