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 ...

We get the latest from the Munich Security Conference, where U.S. Secretary of State Marco Rubio delivered a speech before European leaders. We also look at the reasons behind why the FDA rejected ...

Biotechnology company Moderna (NASDAQ:MRNA) announced in Q4 CY2025, but sales fell by 29.8% year on year to $678 million. Its ...

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.

After a string of high-profile regulatory rebukes, Biohaven’s CEO believes red tape is getting in the way of patient well-being, particularly for those with rare diseases. | After a string of ...

The issue came down to the study design: control group participants over 65 did not receive the high-dose flu shot; instead, ...

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.