More than a hundred E. coli cases were linked to contaminated onions produced by Taylor Farms used in McDonald's burgers.

As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs ...

More than a hundred E. coli cases were linked to contaminated onions produced by Taylor Farms used in McDonald's burgers.

The agency wants applicants to demystify their algorithms and provide specific details about what the models do, how they’re ...

The government agency is tightening its standards for "healthy" claims. And for the first time in 30 years, its labeling rules will be updated to reflect new nutrition standards.

Facing personnel shortages and pandemic disruptions, the U.S. Food and Drug Administration has failed to meet requirements ...

A subsidiary of a Miami-based company is inching closer to FDA approval for a drug that treats a rare pediatric disease.

Patrizia Cavazzoni, leader of the FDA's Center for Drug Evaluation and Research, is leaving the agency on Jan. 18.

The FDA has granted priority review to a Biologics License Application for nipocalimab to treat individuals with generalized ...

The director of the FDA's main drug review office will exit on Jan. 18, according to an email sent to staff. Her departure is ...

The changes reflect “a cultural shift” around obesity medications, said Diana Zuckerman, president of the nonprofit National ...

The FDA’s influential director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, M.D., will soon retire ...