Mushrooms sold across two states have been recalled over fears they could be harboring listeria, a bug that "can cause ...

The FDA's assessment of the bread recall has designated it as a Class II risk, which means the product "may cause temporary ...

Hormone therapy has endured a rather bumpy history after the Women’s Health Initiative published clinical trial data in 2002 ...

The agency claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.

Whoop pushed back on the warning letter, claiming its blood pressure feature for a wearable wristband is for “wellness” and ...

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

New data have strengthened the link between human immune globulin products and the risk for thrombosis, ... FDA: New Boxed Warning for Clot Risk With Immune Globulin - Medscape - Jun 12, 2013.

The US Food and Drug Administration (FDA) has added a boxed warning to the label of the osteoporosis drug denosumab (Prolia) about increased risk for severe hypocalcemia in patients with advanced ...

While I think the FDA was prudent in removing the boxed warning about increased risk for adverse CV outcomes, I am not certain if our results apply to all products.

Shang Hao Jia, Inc. issued a voluntary recall for several cases of Danshi Spicy Shredded Tofu due to possible undeclared sesame.

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