The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for ...

The US Food and Drug Administration has refused to accept an application from Moderna to review its first mRNA seasonal flu vaccine, the company said Tuesday, in another setback for the technology ...

Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused ...

The vaccine maker’s shots involve the successful Covid vaccines’ RNA technology. Health Secretary Robert F. Kennedy Jr. has ...

It’s rare that FDA refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to ...

The FDA agreed to review Moderna’s mRNA flu shot after initially rejecting the filing, reopening the path for the first mRNA-based influenza vaccine.

Moderna held further discussions with regulators and announced that the agency would accept the company’s application for approval of its flu vaccine that uses mRNA technology.

Vinay Prasad, the Trump administration’s top vaccine regulator at the Food and Drug Administration, single-handedly decided to refuse to review Moderna’s mRNA flu vaccine, overruling agency scientists ...

(THE CONVERSATION) The Food and Drug Administration’s decision, made public on Feb. 10, 2026, to not review an application to approve Moderna’s proposed mRNA-based flu vaccine set off a firestorm of ...

In a rare and surprising move, the FDA has issued a “Refusal to File” letter for Moderna’s mRNA-1010 influenza vaccine.

The Food and Drug Administration rejected Moderna's new flu shot. This raises questions about what it means for the future of vaccine development.

Moderna, the vaccine maker, announced on Tuesday that the Food and Drug Administration (FDA) has refused to review its latest concoction, an mRNA-based flu vaccine. “[T]he [FDA] […] ...