The US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research (CBER) is refusing to review Moderna’s application for approval of a new flu vaccine. The decision comes ...

The Food and Drug Administration on Wednesday defended its rejection of Moderna’s mRNA-based flu vaccine application, saying the company’s clinical trial design put patients at risk ...

The FDA rejected Moderna's experimental flu vaccine Tuesday in a move that proved to be a blow to recently hot Moderna stock.

Back in January, Moderna set a planned mpox vaccine on the back burner as the immediate outbreak waned, but now the shot has slid into the priority lane, with entry to the clinic likely a “month or so ...

A Moderna influenza vaccine for avian influenza, or “bird flu,” will head into a pivotal clinical trial with $176 million in funding from the U.S. federal government. The funding announced by Moderna ...

Moderna is preparing to test Health Secretary Robert F. Kennedy Jr.'s tougher vaccine policies with a combination flu-COVID shot. The question is whether it gets approved for both viruses. Why it ...

Moderna revealed Wednesday that its flu vaccine using mRNA technology has offered promising results as the flu season begins to ramp up. Moderna announced that its seasonal flu vaccine “demonstrated ...

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...