The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA ...

The Food and Drug Administration’s recent decision to turn away Moderna’s application for a new flu shot for older Americans ...

After the FDA’s decision to reject a review of Moderna’s mRNA-1010 flu shot, executives explain what Americans will miss out on as other nations embrace the technology.

The Food and Drug Administration rejected Moderna's new flu shot. This raises questions about what it means for the future of ...

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

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.

The company is expecting additional readouts this year from studies of cancer vaccine intismeran autogene, which is being tested in late-stage trials.

The mRNA specialist reiterated its financial estimates for 2026 amid a challenging U.S. regulatory environment where its influenza vaccine just hit a major setback.

Q4 2025 earnings call highlights: revenue, cost cuts, cash outlook, FDA flu setback, and 2026 growth guidance—read key insights now.

Moderna’s mRNA influenza vaccine faces US regulatory delays after a refusal-to-file letter from top FDA official Dr Vinay Prasad.

Moderna (NASDAQ: MRNA) reported fourth-quarter results Friday morning that beat Wall Street’s muted expectations, delivering ...