The FDA needs a few more weeks to decide the fate of Moderna's RSV vaccine, the company announced. A decision is now slated ...
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 (NASDAQ: MRNA) shares are down just over 1% in early Friday trading after the company said the FDA has informed it ...
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" ...
(ブルームバーグ): 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、「事務的な制約」で先送りされたと明らかにした。
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 ...
The FDA hasn't informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent approval, ...
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 ...