The agency was originally scheduled to announce its call on Sunday. The company said it hadn’t flagged any issues with the ...

The FDA needs a few more weeks to decide the fate of Moderna's RSV vaccine, the company announced. A decision is now slated ...

The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.

The U.S. drug regulator has pushed back its decision on Moderna's respiratory syncytial virus (RSV) vaccine due to ...

Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's ...

US regulators’ decision on whether to approve Moderna Inc.’s vaccine for RSV has been delayed due to “administrative constraints” at the Food and Drug Administration, the company said.

Key Takeaways Moderna said the Food and Drug Administration (FDA) has delayed its approval decision for the respiratory ...

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-1345, ...

Novavax stock popped Friday on news of a licensing deal and minority stake from Big Pharma player Sanofi. Moderna stock toppled Friday after the FDA delayed an approval decision on its RSV vaccine ...

Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" ...