The agency was originally scheduled to announce its call on Sunday. The company said it hadn’t flagged any issues with the ...
The FDA needs a few more weeks to decide the fate of Moderna's RSV vaccine, the company announced. A decision is now slated ...
The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
The U.S. drug regulator has pushed back its decision on Moderna's respiratory syncytial virus (RSV) vaccine due to ...
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 ...
(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。
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, ...
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 ...