FDA delays approval for Moderna RSV vaccine

by
Sharing is Caring!

Moderna, Inc. (NASDAQ:MRNA) today announced it has been notified by the U.S. Food and Drug Administration (FDA) that due to administrative constraints, the agency does not expect to complete its review of the Biologics License Application (BLA) for mRNA-1345, Moderna’s investigational respiratory syncytial virus (RSV) vaccine, by the previously communicated Prescription Drug User Fee Act (PDUFA) date of May 12, 2024. The FDA has informed Moderna that it is working to conclude the review by the end of May 2024.

See also  Russia says it has developed a vaccine against cancer that will be rolled out to patients for free.
See also  Tether faces rising regulatory scrutiny as the FSOC warns of systemic risks and is ready to act if Congress delays.

https://investors.modernatx.com/news/news-details/2024/Moderna-Announces-Update-on-Investigational-RSV-Vaccine/default.aspx

h/t A Deplorable Neanderthal