Moderna blames FDA for threatening US leadership in medicine

Moderna Inc. lashed out at the US Food and Drug Administration for making it harder for companies to create new medicines, ...

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 ...
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 ...
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 ...
BioSpace

Moderna’s FDA Challenges Stymie Breakeven Goal in ‘Fresh and Fluid’ Situation

Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.

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

The biotech company said the FDA won’t review its flu vaccine, in the latest hit to mRNA development.