Makary urged the Trump administration to partner with the pharmaceutical industry. ・The senior official is of the opinion that there exists multiple bottlenecks that have caused the U.S. to lag behind ...

The whiplash over a new potential flu vaccine from Moderna, which went from rejected to approved for review in a matter of days, has illustrated a new reality plaguing the Cambridge biotech company ...

The FDA plans to drop its requirement for two studies to approve new drugs, aiming to speed up the availability of medicines.

WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval of new drugs, the latest change from Trump administration ...

Moderna's new flu vaccine application will be reviewed by the FDA after a dispute regarding clinical trial parameters was ...

The Food and Drug Administration's about-face comes a little more than a week after the agency refused to consider the ...

(THE CONVERSATION) The Food and Drug Administration’s decision, made public on Feb. 10, 2026, to not review an application to approve Moderna’s proposed mRNA-based flu vaccine set off a firestorm of ...

WASHINGTON, D.C. - The U.S. Food and Drug Administration (FDA) is set to review Moderna's new flu vaccine made with Nobel prize-winning mRNA technology, reversing course after the agency declined ...

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.

In his report, Senator Bill Cassidy suggested a slate of changes to the FDA to support broader drug access and to reduce ...

The disagreement between Moderna and the FDA has reached a resolution just eight days after the biotech received a Refusal-to ...

Moderna's stock surges after the FDA said it would review the biotech's flu vaccine candidate, a week after it had refused to do so. Shares of Moderna surged Wednesday after the drugmaker got health ...