In a rare and surprising move, the FDA has issued a “Refusal to File” letter for Moderna’s mRNA-1010 influenza vaccine.

Rejecting a recently developed Moderna flu vaccine, the HHS continues to distance itself from mRNA research and development.

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

Moderna is shifting its focus internationally following the U.S. FDA's refusal to review its flu shot. The company plans to ...

Moderna will not commit to previous 2028 breakeven guidance as the ripple effects of the FDA’s refusal-to-file decision spread through its pipeline.

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 ...

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 ...

Reports fourth quarter revenue of $0.7 billion, GAAP net loss of $(0.8) billion and GAAP EPS of $(2.11)Reports ...

Moderna said it is looking for growth overseas after the U.S. FDA refused to review its experimental flu shot and the country ...

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 ...

The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...