The U.S. Food and Drug Administration has approved Avadel Pharmaceuticals' sleep disorder drug for children aged 7 years and ...

Passengers on 200 Delta flights were denied in-flight meal service after food safety issues were discovered in the airline's ...

The Duloxetine Delayed-Release Capsules' voluntary recall began on Oct. 10 after the FDA deemed the medication the ...

It has been a very busy year for food recalls in the United States. The U.S. Food and Drug Administration (FDA) and the U.S.

Thousands of bottles of a commonly prescribed antidepressant drug were recalled because they contained a suspected cancer-causing chemical.

Food companies exploit a loophole in the FDA’s rules that let them self-determine an additive’s safety, yielding obvious ...

The U.S. Food and Drug Administration has declined to approve Camurus' drug for the treatment of a rare hormonal disorder due ...

The FDA has approved a new presentation of Alvotech and Teva’s SELARSDI, for the treatment of ulcerative colitis and Crohn's ...

A class II risk level is given to products that "may cause temporary or medically reversible adverse health consequences." ...

The agency posted documents this week that the drugmaker had requested the drug be placed on the FDA's "Demonstrable ...

Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.

The Food and Drug Administration, in collaboration with the U.S. Customs and Border Protection (CBP), seized about three ...