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 U.S. drug regulator has pushed back its decision on Moderna's respiratory syncytial virus (RSV) vaccine due to ...
The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
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 ...
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 ...
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" ...
Welcome to 2024's regulatory tracker for Fierce Pharma. On this page, we're recording the regulatory progress of in-market products, including expansions into key geographies and new indications.