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 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.

With sales of Immunocore’s melanoma medicine steadily ticking up and an expanded label likely down the line, CEO Bahija ...

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 ...

Mani Foroohar, M.D., of Leerink Partners, says that the decision reflects “how sharp the departure has been between the prior ...

Moderna (MRNA) stock fell 0.3% Friday despite beating Q4 revenue estimates at $678M and posting narrower loss of $2.11/share after FDA rejected flu vaccine review.

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 ...