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Moderna, FDA and RSV vaccine
FDA Delays Decision on Moderna RSV Shot by 3 Weeks
The agency was originally scheduled to announce its call on Sunday. The company said it hadn’t flagged any issues with the drug’s safety, efficacy, or quality.
FDA delays decision on Moderna's RSV shot until the end of May
The FDA needs a few more weeks to decide the fate of Moderna's RSV vaccine, the company announced. A decision is now slated for the end of May, as opposed to May 12.
Moderna Stock Slips as FDA Delays RSV Vaccine Approval
Key Takeaways Moderna said the Food and Drug Administration (FDA) has delayed its approval decision for the respiratory syncytial virus (RSV) vaccine.The biotech reported it was advised by regulators that their review wouldn't be completed until the end of the month,
13d
FDA delays decision date for Moderna's RSV vaccine
Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's ...
clinicaladvisor.com
11d
FDA Decision on Moderna’s mRNA-Based RSV Vaccine Delayed
The
FDA
is working to conclude its review by the end of May 2024. The Food and
Drug
Administration (
FDA
) has informed Moderna that its review of the Biologics License Application (BLA) for mRNA ...
13d
on MSN
FDA Delays 'Important' Moderna Vaccine Review: William Blair Says 2025 Growth, '2026 Breakeven Story' Depends On It
“The product remains an important contributor to Moderna’s return to growth in 2025 and 2026 breakeven story,” William Blair ...
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