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

Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.

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 upcoming influenza season.

At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared against a control shot designed more specifically for older people.

Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused to do so. The post FDA to review Moderna's mRNA flu vaccine after initial ...

With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.

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

The US Food and Drug Administration (FDA) has refused to review Moderna’s seasonal influenza jab, mRNA-1010, as the shifting vaccine landscape within the country continues to prove volatile for pharma ...

The Food and Drug Administration reversed course on Wednesday and agreed to formally review Moderna’s new flu vaccine that uses mRNA technology, the company announced in a news release. Earlier this ...

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.

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.

The Food and Drug Administration has reversed course and agreed to review Moderna’s application for the first mRNA-based flu vaccine under a revised approach, company and federal officials said ...