Moderna said the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application.

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...

Stéphane Bancel, Moderna’s chief executive officer, said that “we appreciate the FDA’s engagement in a constructive Type A meeting and its agreement to advance our application ...

Moderna shares extend gains as FDA reverses its refusal-to-file decision on the firm’s influenza vaccine. Here’s why MRNA ...

Moderna announced the change Wednesday, about a week after revealing that the FDA’s vaccine chief was refusing to review the ...

Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.

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 FDA will review Moderna’s revised application for an mRNA flu vaccine after earlier testing concerns, with approvals being sought for adults 50 and older.

The Food and Drug Administration has reversed its shocking refusal to consider Moderna’s mRNA flu vaccine for approval.

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the ...

After initially rejecting Moderna’s application for review, the FDA will now consider the company’s mRNA flu shot ...

The Food and Drug Administration has reversed course and agreed to review Moderna’s application for the first mRNA-based flu ...