The End the Vaccine Carveout Act would expose vaccine makers to lawsuits that once drove companies out of the industry.

Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA flu vaccine candidate after holding a high-priority meeting with the company.

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

The FDA’s reversal of its earlier refusal to review mRNA-1010, the seasonal flu vaccine being developed by Moderna, accelerated a revival of Moderna shares that has been in progress over recent months ...

The FDA agreed to review Moderna’s experimental mRNA influenza vaccine after Moderna resubmitted its application with modifications.

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

By Bhanvi Satija Feb 27 (Reuters) - Europe's medicines regulator recommended approval for Moderna's COVID and flu combination ...

The Food and Drug Administration has refused to review an application from the biotech company Moderna to approve its mRNA-based flu vaccine. The agency’s decision, which Moderna announced in a press ...

The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA ...

In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for ...

The U.S. Food and Drug Administration is refusing to consider Moderna’s application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.The news is the ...