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 ...
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) ...
(RTTNews) - Moderna, Inc. (MRNA) announced Friday that the U.S. Food and Drug Administration's review of the Biologics License Application or BLA for mRNA-1345, its investigational respiratory ...
The FDA has not informed Moderna of any issues related to vaccine safety, efficacy, or quality that would prevent the approval of mRNA-1345. Moderna remains on track for mRNA-1345 to be reviewed ...
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 ...