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 ...

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.

Food and Drug Administration. FDA approves required updated warning in labeling of mRNA COVID-19 vaccines regarding myocarditis and pericarditis following vaccination. Posted on: June 25, 2025.

Texas will put warning labels on some foods, but its additives list has inaccuracies Texas would be the first in the U.S. to use warning labels to target additives, rather than nutrients like ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These are the key takeaways.

From AI-powered inspections to bold regulatory shifts on dyes and sugar, the FDA has made waves in 2025. Here are the 17 most impactful stories shaping the future of food regulation.