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 ...
The U.S. Food and Drug Administration (FDA) recently informed Moderna that it would not review the company’s application for approval of its new flu vaccine, which is its first using mRNA technology ...
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.
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 ...
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, ...