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 FDA’s decision is important for Moderna, which is counting on the shot, known as mRNA-1345, to become ts second marketed product. The vaccine is being developed to prevent disease related to ...
The regulator cited “administrative constraints,” rather than any issue with Moderna’s trial data, for missing a May 12 deadline, the company said.
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。
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 ...
opens new tab respiratory syncytial virus (RSV) vaccine due to "administrative ... "We don't expect major delays from here onwards and FDA should be able to approve this by end of May," Jefferies ...
Plexi Images / GHI / UCG / Universal Images Group via Getty Images Moderna said the Food and Drug Administration (FDA ... approval decision for the respiratory syncytial virus (RSV) vaccine.
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" at the agency. The FDA was originally expected to make a decision on ...