According to reporting from Reuters, reviewers at the agency pointed to an inability to differentiate from placebo to justify rejecting the drug, but an FDA office director approved the drug anyway.

FDA approved a pricey rare disease drug in September despite findings by its data reviewers that the treatment, while safe, ...

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to M2T-CD33 (LTI-214) for the treatment of ...

The FDA sent warning letters to fluoride supplement manufacturers telling them not to promote the products for use in young kids.

Sales and production of the sauces made by First and Last Bakery have been suspended to ensure compliance with regulations, ...

The FDA announced it will relax certain rules for approving low-cost versions of some high-priced medications.

The FDA has approved Kygevvi (doxecitine and doxribtimine) for the treatment of TK2d in adults and pediatric patients with an age of symptom onset on or before 12 years.

The Food and Drug Administration has announced the recall of thousands of makeup remover wipes because they may be ...

The FDA has approved Rybelsus® to reduce the risk of MACE in adults with T2DM who are at high risk for these events.

The FDA warned consumers about potential serious adverse events linked to radiofrequency microneedling procedures.

The head of the U.S. Food and Drug Administration’s drug division, Dr. George F. Tidmarsh, resigned on November 2, 2025, one ...

The Food and Drug Administration awarded the drug’s sponsor, biotech company Revolution Medicines, a new and unconventional ...