Key Takeaways Moderna said the Food and Drug Administration (FDA) has delayed its approval decision for the respiratory ...
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 ...
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" ...
The FDA hasn't informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent approval, ...
(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 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 approved a liquid mycophenolate to prevent organ rejections but delayed the approval of Moderna’s RSV vaccine.
Moderna Inc.’s stock fell 2.6% Friday, after the company said the Food and Drug Administration will not complete its review of the company’s respiratory syncytial virus, or RSV, vaccine by the ...
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 ...
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 ...