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.
Just days before its initial deadline, U.S. regulators say they need more time to decide whether or not to approve Moderna's ...
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。
The U.S. drug regulator has pushed back its decision on Moderna's respiratory syncytial virus (RSV) vaccine due to ...
Moderna shares fell in intraday trading Friday as it said the FDA has pushed back its RSV vaccine approval decision until the ...
The FDA has not informed Moderna of any issues related to the vaccine's safety, efficacy or quality that would prevent its ...
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, the company said.
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 announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" ...