FDA Roundup: May 31, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA approved mRESVIA (Respiratory Syncytial Virus Vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. mRESVIA is an mRNA-based vaccine that is manufactured by Moderna ModernaTX, Inc. Today, the FDA issued a final rule to implement our new authority, under the Safeguarding Therapeutics Act (Pub. L. 116-304) that was signed into law on January 5, 2021, to administratively destroy human or animal devices valued at $2500 or less (or such higher amount as the Secretary of ...