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

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

Moderna is breathing a sigh of relief now that the Food and Drug Administration said on Wednesday that it will review the ...

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

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

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

Experts say new labeling could deceive consumers as dangerous substances still allowed under new rules ...

Sibel Health has received acceptance from the US Food and Drug Administration (FDA) into the clinical outcome assessment (COA ...

Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused ...

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

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

Moderna announced that the FDA agreed to review its application for a mRNA-based flu vaccine after it agreed to further study in older adults.