Moderna Inc. said it has “voluntarily” withdrawn its application for regulatory approval for its combination Covid and flu shot for people 50 and over, a setback for the company.The biotech company said it made the decision after consulting with the Food and Drug Administration.

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.

The FDA plans to limit access to certain high-risk groups and also told Pfizer and Moderna to update their warning labels about heart inflammation.

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.

Moderna has withdrawn the Biologics License Application (BLA) for mRNA-1083, a combination vaccine against seasonal influenza and SARS-CoV-2, after

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,

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The Trump administration shared the outlines of how it plans to push drug companies to lower their prices in the U.S.