Some U.S. health regulators who review medical devices and tobacco products for safety and efficacy are struggling to meet ...

Viagra was approved by the U.S. Food and Drug Administration 27 years ago. Experts say it immediately changed the way we talk ...

Denosumab-bnht is expected to launch in the US in June 2025 per an agreement with the reference product’s manufacturer, Amgen ...

Critics worry that the user fee program creates a conflict of interest between the FDA and pharmaceutical companies.

Deputy directors at the FDA center that oversees the regulation of cancer drugs plan to leave, adding to a flood of top ...

A pill used in most U.S. abortions has been ensnared in politics for years, and many Americans wonder whether it will be ...

Around 3,500 employees are on the chopping block at the Food and Drug Administration, but they don’t yet know who they are.

For people with heart conditions, high blood pressure, or who are pregnant, accidentally consuming caffeine can lead to ...

Sen. Jim Banks (R-Ind.) wants the Food and Drug Administration to look into foreign-made active pharmaceutical ingredients he ...

The U.S. Food and Drug Administration on Wednesday approved Soleno Therapeutics' drug to treat a rare genetic disorder, ...

Diazoxide choline is the first drug indicated for hyperphagia in the rare genetic disorder. Prior to approval, people with ...

The FDA recently approved the first treatment in nearly 30 years for acute stroke, and the agency also approved a novel drug ...