The Antimicrobial Drugs Advisory Committee (AMDAC) has scheduled a meeting on Thursday June 08, 2023, through an online teleconferencing platform. During the meeting, the committee will discuss  biologics license application (BLA 761328), for Nirsevimab, a long-acting respiratory syncytial virus (RSV) F protein inhibitor monoclonal antibody for intramuscular use, submitted by AstraZeneca. The proposed indication is prevention of RSV lower respiratory tract disease in neonates and infants born during or entering their first RSV season and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.