It will be co-led by Patrizia Cavazzoni, director of the FDA's Centre for Drugs Evaluation and Research (CDER), and Centre for Biologics Evaluation and Research (CBER) director Peter Marks.

The agency first declared a shortage of semaglutide, the main ingredient used to make Ozempic and Wegovy, in 2022.

FDA Commissioner Dr Marty Makary. The FDA is moving at breakneck speed to roll out a generative artificial intelligence (AI) tool for speeding up regulatory reviews, announcing its launch nearly a ...

For the first time since 1998, the U.S. Food and Drug Administration is expected to review the nutrients and other ingredients in formula.