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

The FDA asked Sarepta Therapeutics to halt shipments of its Elevidys gene therapy after a patient's death linked to a similar treatment. Sarepta will continue shipments for ambulatory patients but ...

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

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

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 ...

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

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

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

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, under Health Secretary Robert F. Kennedy Jr., has taken another step to question the safety of Covid-19 vaccines.

Discover the latest FDA warning updates for COVID vaccines including increased health risks and new restrictions for healthy adults.