Rumbling beneath the Trump administration’s hostility toward mRNA vaccines has been a larger question of whether the FDA will ...

THE VACCINE MAKER MODERNA decided this past week to tell the world about bad news it had received from the federal government ...

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

The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company ...

FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.

Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns ...

Friday, February 13th, 2026 As far as economic reports go, the good news just keeps on coming. Seemingly running on a separate track from investor fears about AI’s future role in the economy, today’s ...

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...

MRNA is showing early signs of a new bull trend after earnings beat expectations, with technical support holding and upside targets forming above key resistance levels.

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 ...

Moderna received a surprise refusal from the FDA to review its updated flu vaccine, highlighting the ongoing struggle between vaccine makers and a vaccine-skeptical HHS.

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has requested a Type A meeting to understand the path forwardmRNA-1010 has been ...