Moderna on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for respiratory syncytial virus due ... t expect major delays from here ...
Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's ...
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" ...
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.
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 ...