FDA Will Approve COVID-19 Vaccine
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Moderna isn’t giving up on the combo shot entirely—it plans to resubmit later this year after it collects more data from its Phase III trials, which test how well a new treatment works compared to existing options.
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate after discussions with the U.S. Food and Drug Administration. The company said it would resubmit the application later this year with vaccine efficacy data from a late-stage trial of its experimental seasonal influenza vaccine,
FDA COVID vaccine update is stirring major public attention as a new policy limits fall COVID-19 booster shots to seniors and high-risk individuals. While the FDA met to decide if vaccine formulas should change for fall 2025,
The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from yesterday.
Advisers to the FDA will debate if the virus has mutated enough since last winter to require a tweak to the formula.
Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after
Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,
The Trump administration shared the outlines of how it plans to push drug companies to lower their prices in the U.S.