Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's ...
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 ...
First, a bit of background on Moderna's RSV candidate. RSV generally causes cold-like symptoms, but the virus could be severe ...
Moderna (NASDAQ:MRNA) announced Friday that the U.S. Food and Drug Administration (FDA) has pushed back its timeline to complete the review of its marketing application for mRNA-1345, a messenger ...
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 ...