The FDA needs a few more weeks to decide the fate of Moderna's RSV vaccine, the company announced. A decision is now slated ...
Moderna on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for respiratory syncytial virus due to “administrative constraints,” extending a ...
The FDA has not informed Moderna of any issues related to the vaccine's safety, efficacy or quality that would prevent its ...
Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's ...
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 ...
Moderna on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for respiratory syncytial virus due to “administrative constraints ...
Key Takeaways Moderna said the Food and Drug Administration (FDA) has delayed its approval decision for the respiratory ...
Moderna (NASDAQ: MRNA) shares are down just over 1% in early Friday trading after the company said the FDA has informed it that it will not be able to meet the May 12 PDUFA for their RSV vaccine due ...
, opens new tab respiratory syncytial virus (RSV) vaccine due to "administrative constraints" and will complete the review by the end of this month, the company said on Friday. Moderna's shares ...