Federal documents show he disagreed with conclusions the benefits outweighed the risk of side effects, which are rare.

The FDA now requires ADHD extended-release drug labels to warn of weight loss risks in children under 6, urging monitoring ...

Lynozyfic (linvoseltamab) has been given accelerated approval by the US regulator for adults with relapsed or refractory ...

Lupin Limited secures FDA approval for Loteprednol Etabonate Ophthalmic Gel, enhancing treatment options for postoperative ...

The FDA has upgraded Alma Pak’s blueberry recall to the highest risk level following positive tests for Listeria ...

The FDA has approved Gamifant as the first-ever treatment for macrophage activation syndrome in Still’s disease for adults ...

WASHINGTON — Jacqueline Corrigan-Curay, the top drug regulator at the Food and Drug Administration, is retiring from the ...

With the FDA recently rejecting a drug application that aims to help those living with Barth Syndrome, one Bay Area family is ...

ProPublica spent 14 months investigating the FDA’s oversight of foreign drugmakers that send medications to the U.S. These ...

The FDA has accepted Aquestive Therapeutics’ new drug application for its Anaphylm sublingual epinephrine film for treating ...

Curay, the top FDA drug regulator, acknowledged that much is still in flux at the agency and introduced a new deputy.