The agency was originally scheduled to announce its call on Sunday. The company said it hadn’t flagged any issues with the ...
US regulators’ decision on whether to approve Moderna Inc.’s vaccine for RSV has been delayed due to “administrative ...
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 ...
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 ...
The U.S. drug regulator has pushed back its decision on Moderna's respiratory syncytial virus (RSV) vaccine due to ...
The FDA has not informed Moderna of any issues related to the vaccine's safety, efficacy or quality that would prevent its ...
What difference does a few weeks make? Moderna will have to consider that after receiving word that the FDA will not meet a May 12 decision date for its respiratory syncytial virus (RSV) vaccine ...
Moderna shares fell in intraday trading Friday as it said the FDA has pushed back its RSV vaccine approval decision until the ...
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, ...
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" ...