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

Nirwana Foods recalls 28-oz golden raisins for undeclared sulfites that could cause life-threatening allergic reactions.

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 ...

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 ...

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% ...

The U.S. government is nixing a whole slew of "obsolete" U.S. food standards that Trump administration officials say also ...

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

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