The agency was originally scheduled to announce its call on Sunday. The company said it hadn’t flagged any issues with the ...
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 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 ...
Moderna shares fell in intraday trading Friday as it said the FDA has pushed back its RSV vaccine approval decision until the ...
s respiratory syncytial virus (RSV) vaccine. Moderna (Nasdaq: MRNA) had originally expected a decision ... the FDA’s update on its review of the RSV vaccine. “Although regulatory delays ...
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 ...
(関連記事:モルモット: ファイザー社は、早産につながる新しいRSVワクチンで妊婦を実験するFDAの承認を取得した) 「RSVは小児の病気の一般的な原因であり、乳幼児は入院につながる重篤な病気になるリスクが最も高い人たちの一人である」と当時FDA ...
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, ...