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

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

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

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

Your morning coffee ritual is usually a simple pleasure, but a recent recall of certain coffee pods might make you ...

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

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

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

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

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.

The FDA issued its highest-level risk warning for a recent voluntary recall of hundreds of boxes of organic blueberries ...