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 ...
Key Takeaways Moderna said the Food and Drug Administration (FDA) has delayed its approval decision for the respiratory ...
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 on Friday said the Food and Drug Administration has postponed an approval decision on its experimental vaccine for ... t expect major delays from here onwards and FDA should be able ...
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.
Moderna announced that the FDA had delayed approval of its RSV vaccine to the end of May due to "administrative constraints" ...
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 ...
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 ...