For selected applicants, the agency plans to cut review times down to one to two months and provide "tumor board-style" ...

The U.S. Food and Drug Administration announced Thursday it halted all new clinical trials that entail sending Americans’ ...

Qualifying manufacturers will be able to submit some data while clinical trials are ongoing. Marty Makary is the commissioner ...

FDA Commissioner Marty Makary has told staff that Center for Biologics Evaluation and Research Director Vinay Prasad has been ...

The U.S. Food and Drug Administration (FDA) today announced an immediate halt to new clinical trials that were shipping ...

The Food and Drug Administration (FDA) announced a new crackdown Wednesday on the flow of American DNA to labs in China and other adversaries. The FDA previously […] ...

A listeria outbreak in refrigerated pasta causes three deaths and one pregnancy loss. FreshRealm recalls chicken fettuccine alfredo sold at Walmart and Kroger.

To hear some of them tell it, the companies selling continuous glucose monitors have stumbled upon a heretofore unknown quirk ...

The program significantly shortens the FDA review time for a sponsor's final drug application submission from approximately 10-12 months to 1-2 months.

Two major food companies will begin removing artificial dyes from their products, as per the recommendations made by the Department of Health and Human ...