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 ...

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 issue came down to the study design: control group participants over 65 did not receive the high-dose flu shot; instead, they received a regular flu shot. Moderna CEO Stéphane Bancel said the FDA ...

Amidst shifting regulatory landscapes, the federal agency issues a rare procedural rejection regarding a respiratory immunization candidate, sparking debate over clinical trial standards and future ...

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.

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

Moderna beat fourth-quarter sales expectations and forecast growth for 2026, but an FDA refusal on its flu vaccine raises new ...

HealthDay News — In a major blow to vaccine development, the US Food and Drug Administration (FDA) said it will not review Moderna’s application for the first mRNA-based flu shot. Dr Vinay Prasad, the ...

Moderna (MRNA) stock trades flat as the company beats with its Q4 2025 results and reaffirms 2026 growth target despite FDA setback for flu shot. Read more here.

This is our FDA today. Quack nostrums get approved based on “incredible stories”, while vaccines get dismissed out of hand despite multiple successful RCTs. Our FDA leaders call this “ gold-standard ...