Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.
If approved, mCOMBRIAX would become the first combination Covid-flu jab to gain regulatory approval anywhere across the globe ...
Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...
At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared against a control shot designed more specifically for older people.
The Food and Drug Administration will consider whether to approve Moderna’s new flu vaccine after all, resolving a dispute that had blocked the company’s application for the first-of-its-kind shot.
In issuing a positive recommendation, the EMA has diverged from the FDA, which has set higher approval standards for Moderna’s vaccine in the U.S.
The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.
The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.
With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.
FILE - A sign marks an entrance to a Moderna building in Cambridge, Mass., May 18, 2020. (AP Photo/Bill Sikes, File) FILE - A sign marks an entrance to a Moderna building in Cambridge, Mass., May 18, ...
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