Nirwana Foods recalls 28-oz golden raisins for undeclared sulfites that could cause life-threatening allergic reactions.

Oncologic Drugs Advisory Committee (ODAC) voted against the overall benefit/risk profile at the proposed dosage of GSK plc’s ...

Kayem Foods Inc. has issued a voluntary recall for more than 24,000 pounds of its Sweet Apple Chicken Sausages.

The U.S. Food and Drug Administration raised concerns over ink printing potentially running when exposed to high temperatures.

And Go Concepts LLC announced a voluntary recall for a range of vegetable products on May 27 due to potential listeria ...

FDA issues warning letters to distributors of food, dietary supplements and unapproved drugs that contain ...

Second patient death from liver failure after Sarepta's Elevidys gene therapy triggers FDA investigation. Stock crashes 41% ...

Members of an FDA expert panel discussed reassessing boxed warnings for menopausal HT and how to better educate patients and ...

Based on peer-reviewed research from leading experts, highly concentrated or semi-synthetic 7-OH products pose significant ...

The FDA asked Sarepta Therapeutics to halt shipments of its Elevidys gene therapy after a patient's death linked to a similar treatment. Sarepta will continue shipments for ambulatory patients but ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The Food and Drug Administration has expanded warnings about a rare heart side effect rarely seen in young men who take the two leading Covid-19 vaccines.