Fierce Biotech

UPDATE: After Moderna's rebuke, HHS stands behind FDA decision to spurn mRNA flu filing

"The FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to ...
Just The News

Moderna threatens American jobs after FDA snubs mRNA flu shot, trial looked 'scientifically lax'

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 ...
Fierce Pharma

With the FDA's Moderna decision, vaccine makers face increasingly uncertain regulatory environment

Mani Foroohar, M.D., of Leerink Partners, says that the decision reflects “how sharp the departure has been between the prior ...
BioPharma Dive

FDA refuses to review Moderna’s mRNA flu vaccine

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

Wall Street eyes Moderna earnings after FDA rebuff

Moderna will report its fourth-quarter 2025 earnings this morning in an investor call that’s taken on even more interest in ...

Moderna’s work developing seasonal vaccines is ‘risky’ under current FDA, analyst says

The biotech announced Tuesday evening that in a rare move, the Food and Drug Administration won’t review its application for ...