Julie Morgan
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reversing an earlier stance to refuse its review.
In a press release, the biotech said that the agency has also assigned August 5th of this year as the target action date in connection with its biologics license application for mRNA-1010.
Shares of Moderna came under pressure last week after the FDA issued a refusal to file letter indicating that its biologics unit, which regulates vaccines, would not review the BLA.
The company has submitted an amended BLA after proposing a revised regulatory path for the shot.
during a type A meeting with the FDA.
Changes include plans to seek an age-dependent regulatory pathway and a post-marketing requirement to conduct an additional trial in older adults.
Moderna expects to launch mRNA 1010 in the U.S.
for adults age 50 and older for the 2026-2027 flu season.
Now for a look at a few other articles that are trending.
GameStop's Ryan Cohen takes on the hollow men of corporate boardrooms.
A shift away from EVs continues to cost Avis' budget.
And Figma targets 30% revenue growth for 2026 as AI adoption accelerates.
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On Wall Street at this early hour, Dow, S&P and Nasdaq futures are in the red.
Crude oil is up 1% at $65 a barrel.
Bitcoin is up 0.6% at $66,000.
Gold is up 0.2% at $49.85.
The FTSE 100 is down 0.8% and the same is true for the DAX.
Chinese and Hong Kong markets were closed today for the Lunar New Year holiday.
We mentioned Figma earlier in an article that is trending.