The FDA has flagged a packaging defect involving a well-known coffee brand, prompting a nationwide recall for specific single ...

Dozens of lawmakers are urging US health regulators to crack down on the booming market for knockoff weight-loss drugs amid ...

The U.S. Food and Drug Administration said on Friday that it is investigating the death of an 8-year-old boy who received Elevidys, a Sarepta Therapeutics ( NASDAQ: SRPT) gene therapy for Duchenne ...

Commissioner Marty Makary said in an interview with Politico’s Dasha Burns that the FDA will “look at the data” surrounding ...

New Mexico Pinon Coffee has recalled its 10-count single-serve coffee pods after discovering a production issue that may ...

The FDA is still on track to meet its user fee targets despite a higher-than-normal vacancy rate among scientific reviewers.

Welcome to our live blog tracking the latest news and developments from the United States. Stay updated with real-time ...

The U.S. drug regulator said on Friday a unit of Johnson & Johnson issued a correction for certain lots of a part related to ...

Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug ...

On Nov. 26, 2019, ChemoCentryx issued a press release announcing that the Advocate trial met both of its primary endpoints, saying Tavneos showed noninferiority of disease remission at 26 weeks and ...