The head of the US Food and Drug Administration said the agency will start publishing the rejection letters that companies ...

Weaver Nut Company, Inc. announced a recall for specific lots of its semi-sweet chocolate nonpareils on June 17 due to the undeclared presence of milk.

Used for diagnosing gastroesophageal reflux, the devices may not attach or detach correctly, potentially causing serious ...

Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...

Pro-life medical groups are urging Health and Human Services Secretary Robert Kennedy Jr. to reexamine the FDA’s broad ...

Merck on Thursday said the application covers the investigational, once-daily, oral two-drug regimen for adults with HIV-1 infection that is virologically suppressed on antiretroviral therapy. The ...

The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s work, current ...

The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.

The company completed a clinical trial at nine centers across the U.S., Europe and Asia before it received FDA approval.

The FDA has approved garadacimab-gxii for prophylactic use in patients aged 12 years and older with hereditary angioedema, ...

Fuentes Farms LLC announced a voluntary recall of 71 boxes of fresh cucumbers on June 13 due to potential salmonella ...

Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.