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

Health Secretary Robert F. Kennedy Jr. has spent years campaigning against vaccines, but with the flu shot, he’s suggested it ...

RFK Jr.'s attacks on vaccines go beyond changing the childhood immunization schedule. Now he's taking aim at vaccine R&D itself.

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 ...

In a rare and surprising move, the FDA has issued a “Refusal to File” letter for Moderna’s mRNA-1010 influenza vaccine.

Experts say ‘they’re just coming up with reasons’ as agency says application lacked ‘adequate and well controlled’ trial ...

The FDA has refused to review Moderna’s application for its messenger RNA-based influenza vaccine, according to the company.In a press release, Moderna noted that the FDA’s rejection of the vaccine, ...

Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns despite no safety flags.

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 ...

Failure to obtain informed consent can result in significant consequences Exceptions to informed consent apply only in limited circumstances Elements of valid informed consent include patient capacity ...

Since it was first detected in the U.S. in 2014, H5N1 avian influenza, commonly known as bird flu, has jumped from wild birds to farm animals and then to people, causing more than 70 human cases in ...