Twelve Infants Die During Clinical Trials for FDA-Endorsed RSV Drug

On June 8, 2023, the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted unanimously (21-0) in favor of AstraZeneca and Sanofi’s new nirsevimab (Beyfortus) monoclonal antibody drug believed to provide protection for infants from respiratory syncytial virus (RSV) disease and other lower respiratory tract infections during their first year of life.1 […]

RSV Vaccine Approved by FDA for Adults 60 and Older

The U.S. Food and Drug Administration (FDA) has approved a license for the world’s first respiratory syncytial virus (RSV) vaccine to be given to people 60 years of age and older. Pharmaceutical and biotechnology company GSK (formerly GlaxoSmithKline) has already begun manufacturing doses of the vaccine, which will be sold as early as this fall […]