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.
Moderna on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for respiratory syncytial virus due ... t expect major delays from here ...
The Cambridge company said the FDA cited “administrative constraints” in its decision to push back the PDUFA ... Analysts ...
Moderna shares fell in intraday trading Friday as it said the FDA has pushed back its RSV vaccine approval decision until the ...
The Food and Drug Administration (FDA) has informed Moderna that its review of the Biologics License Application (BLA) for mRNA-1345, an investigational respiratory syncytial virus (RSV) vaccine, will ...
Moderna (NASDAQ: MRNA) shares are down just over 1% in early Friday trading after the company said the FDA has informed it ...