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 ...
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 ...
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" ...
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 syncytial virus or RSV vaccine, will ...
米バイオテクノロジー大手 モデルナは10日、呼吸器合胞体ウイルス(RSV)ワクチンの承認可否に関する米食品医薬品局(FDA)の決定が ...
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 (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 ...
or RSV, vaccine by the original deadline of May 12. The FDA cited administrative constraints for the delay, Cambridge, Mass.-based Moderna said in a statement. The regulator has told the company ...
Moderna on Friday said the Food and Drug Administration won't meet its May 12 target action date for a decision on the company's proposed vaccine for respiratory syncytial virus, or RSV ...
The FDA has not informed ... 1345 demonstrated vaccine efficacy of 83.7% against RSV lower respiratory tract disease. William Blair writes that although regulatory delays are disappointing ...