The agency was originally scheduled to announce its call on Sunday. The company said it hadn’t flagged any issues with the ...
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 ...
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 ...
Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's ...
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 ...
The Food and Drug Administration (FDA) has informed Moderna that its review of the Biologics License Application (BLA) for mRNA-1345, an investigational respiratory syncytial virus (RSV) vaccine, will ...
Moderna (NASDAQ: MRNA) shares are down just over 1% in early Friday trading after the company said the FDA has informed it ...
(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" ...