Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.
Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...
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.
If approved, mCOMBRIAX would become the first combination Covid-flu jab to gain regulatory approval anywhere across the globe ...
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.
With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.
Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused to do so. The post FDA to review Moderna's mRNA flu vaccine after initial ...
Moderna has managed to eke out some temporary wins, paving the way for the homegrown biotech to focus on its next moves.
Andrew Egger and Jonathan Cohn give their takes on the stunning back-and-forth at the FDA over Moderna’s new mRNA flu vaccine ...
By Bhanvi Satija Feb 27 (Reuters) - Europe's medicines regulator recommended approval for Moderna's COVID and flu combination vaccine on Friday, putting it on track to become the first single shot to ...