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.

An AI system developed to predict a patient's response to immunotherapy could help "democratize" access to the pricey drugs ...

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

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

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

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

On second thought, the FDA figures it no longer needs to discuss Exelixis’ application for Cabometyx in neuroendocrine tumors ...

D Molecular Therapeutics reaches agreement with FDA for phase 3 trial design of DME candidate 4D-150, showing promising ...