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 ...

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.

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

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

The Class I recall status indicates that the product poses a risk of causing serious health consequences or death if consumed ...

Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...

OREGON – The FDA has issued a recall for a brand of baby food following reports of lead poisoning in Oregon. The product in question is the Good and Gather ...

The FDA has published its proposed agenda for 2025 guidance, including new topics such as food colorings. Topics on the agenda are a priority for the Food ...

These updates support FDA’s ongoing efforts to help ensure that food labeling is truthful, not misleading, and compliant with federal regulations, the agency said. The updated program aims to enhance ...

In a bold new move, Texas passed a law that mandates warning labels on foods containing additives banned in parts of the world. From food dyes to titanium dioxide, these chemicals are in thousands ...

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.