Thousands of units have were potentially contaminated with a radioactive substance, which can increase the risk of cancer.

Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...

A system that allows drug makers to profit from restricted access will never liberalize on its own—and patients will continue ...

This move is another step in Makary’s attempts to shorten FDA reviews, which started when he began his tenure last year. 3 These include mandating the use of artificial intelligence for staffers and ...

The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies for new drug approvals.

In a NEJM article, Commissioner Martin Makary and top deputy Vinay Prasad argued that the new policy should lower development costs and speed development without compromising agency standards.

Makary helms the FDA in the midst of a contentious stretch for the agency, defined by massive staff and budget cuts and sweeping changes to vaccine policy.

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

Health Secretary Robert F. Kennedy Jr. said the agency would "act on" a high-profile petition to reassess safety of high fructose corn syrup and other refined carbohydrates.

Rick Abrmason, formerly a chief medical officer at a subsidiary of Harrison.ai, which develops AI products to interpret ...

The US Food and Drug Administration has reversed course and will review a new mRNA flu vaccine from Moderna, the ...

The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA ...