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

The FDA has issued Class I recalls for chocolate products due to undeclared allergens and contamination—posing serious health ...

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

Experts on the panel shared many of the same views around SSRIs, arguing that the risks of the drugs during pregnancy are greater than currently accepted.

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

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

There were warnings to the FDA about Sarepta Therapeutics Inc. before US regulators asked the company to halt shipments of its gene therapy.

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

Dr. Marty Makary, the agency’s commissioner, said too many women avoid hormone therapy because the risks have been overstated ...

The new law will require labels on foods containing 44 dyes or additives commonly found in the country’s food supply, such as in baked goods, candy and drinks.

Sarepta Therapeutics has paused U.S. shipments of its gene therapy Elevidys after two teenagers with Duchenne muscular ...

New and disturbing concerns about fake GLP-1 drugs are cited in a letter sent to the FDA by Tennessee officials, including Sen. Marsha Blackburn.