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

The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use ...

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

Regeneron Pharmaceuticals has won FDA accelerated approval of its Lynozyfic treatment for certain patients with the blood ...

Records show that a top U.S. regulator rejected the recommendations of agency experts and limited the use of Covid vaccines.

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

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

The US Food and Drug Administration (FDA) has issued a Class I recall—its highest alert level—on a batch of organic ...

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