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.
The FDA has not informed Moderna of any issues related to the vaccine's safety, efficacy or quality that would prevent its ...
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 ...
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, as the company works ...
The FDA hasn't informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent approval, ...
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" ...
Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's ...
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 ...