The FDA declined to review Moderna's mRNA influenza vaccine due to inadequate clinical trial comparators for older adults.

In its main clinical trial, mRNA-1010 was shown to be 26.6% more effective than the comparator flu shot in adults aged 50 ...

In a news release late Tuesday, Moderna said it was blindsided by the FDA’s refusal, which the FDA cited as being due to the design of the company’s Phase 3 trial for its mRNA flu vaccine, dubbed mRNA ...

Moderna (MRNA) stock fell 9% premarket after FDA rejected its flu vaccine application due to trial design issues, despite ...

U.S. FDA issues a Refusal to File for Moderna's mRNA flu vaccine BLA, citing concerns with the trial comparator rather than ...

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...

Drug observers puzzled by vaccine maker, which made a killing on COVID-19, failing to read the room with new administration. Moderna puts heat on FDA vaccines chief who's already been rebuked once by ...

A regulatory setback for Moderna’s next-generation flu vaccine underscores mounting scrutiny of late-stage trial design in the U.S., even as the company pivots to international manufacturing ...

The move is further in line with HHS Secretary Kennedy's anti-vaccine policies ...

Moderna said the move is inconsistent with previous feedback from the FDA on the experimental influenza shot, called mRNA-1010.

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 ...

There is a comfortable lie built into most commentary about war and “strategy.” The lie is that when power talks about survival, it is talking about the survival of a society. It is not. In many ...