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 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 ...
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, as the company works ...
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 ...
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。
opens new tab respiratory syncytial virus ... vaccine's use and the intended population, and success there is necessary for commercial launch. "We don't expect major delays from here onwards and ...
The FDA hasn't informed Moderna of any issues related to vaccine safety, efficacy or quality that would prevent approval, ...
The Food and Drug Administration's move prolongs the wait for Moderna's second approved product, but the company said the vaccine remains on track to be reviewed by a panel of advisers at the U ...