An ethics complaint leads to a resignation, and the agency shifts approval standards.

The government isn’t the only arbiter of product quality.

The U.S. Food and Drug Administration said on Thursday it has awarded six more companies, including Eli Lilly and Novo ...

FDA issues Class II recall for ADHD drug after quality concerns, with millions of prescriptions potentially impacted.

The FDA has sent warning letters to 18 websites selling counterfeit or unapproved versions of Botox and similar injectable ...

U.S. health regulators on Wednesday sent warning letters to 18 websites selling counterfeit or unapproved versions of Botox ...

Johnson & Johnson said on Thursday it has asked U.S. health regulators to authorize its single-dose COVID-19 vaccine for ...

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

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

For the first time, patients with abnormal cells detected in their bone marrow have a treatment option before the condition ...

The FDA has updated the label indication for linaclotide capsules for the treatment of irritable bowel syndrome with ...

CINCINNATI (WXIX) - A Cincinnati-based medical startup is seeking the U.S. Food and Drug Administration’s approval for a ...