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

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

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

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

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

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

The regulator had asked Sarepta Therapeutics to halt all shipments of its therapy, Ele­vidys, after three patients died from ...

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

The Food and Drug Administration has issued a recall for more than 67,000 cases of Power Stick deodorant products for not ...

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

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

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