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 ...
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 ...
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 ...
(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 approved a liquid mycophenolate to prevent organ rejections but delayed the approval of Moderna’s RSV vaccine.
Regulator has told the biotech it expects the review will be done by the end of May Moderna Inc.'s stock fell 2.6% Friday, after the company said the Food and Drug Administration will not complete ...
The Food and Drug Administration's move prolongs the wait for Moderna's second approved product, but the company said the vaccine remains on track to be reviewed by a panel of advisers at the U ...
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 due to ...