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 ...

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 ...

Moderna's mRNA technology gained rapid validation as sales of its covid vaccine soared in 2021 and 2022, but we think the firm has yet to secure a narrow economic moat around its business, largely due ...

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.

Here are some of the biggest movers in midday trading. Moderna – Shares of the biotech giant climbed 5% after the company ...

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