The combination shot comprises a new COVID vaccine and an influenza vaccine, both under development by Moderna. The company has previously said it does not expect a delay in the FDA's decision for ...

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 ...

After the FDA asked for more clinical data in May 2025, Moderna has decided to resubmit the BLA later this year.

Moderna, Inc. (NASDAQ:MRNA) today announced that it had voluntarily withdrawn the pending Biologics License Application (BLA) seeking approval for its COVID-19 and Influenza combination vaccine ...

(Bloomberg) -- Moderna Inc. said it has “voluntarily” withdrawn its application for regulatory approval for its combination Covid and flu shot for people 50 and over, a setback for the company.

Moderna's decision to withdraw its flu-Covid combo vaccine application comes on the heels of significant changes in FDA approval policies for Covid vaccines. Boston biotech’s strategic review ...

Moderna said on Wednesday it has withdrawn an application seeking approval for its flu and COVID combination vaccine candidate to wait for efficacy data from a late-stage trial of its influenza shot,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

Moderna has withdrawn its pending application for a combination vaccine for both the flu and Covid-19, saying it will resubmit later this year once it has more data. The maker of the Spikevax ...

After discussions with the Food and Drug Administration, Moderna on Wednesday said it has voluntarily withdrawn its application for a combination COVID-19 and influenza shot in adults aged 50 ...