The U.S. Food and Drug Administration is moving to fast-track reviews of two experimental Merck drugs with ...

FDA moves reshaping drug policy include fast-track programs, updated biosimilar guidance, and new rare disease approval pathways.

U.S. health regulators informed senior executives at Merck, Sanofi and AstraZeneca last week that their approved protective RSV treatments for infants would face fresh safety scrutiny following ...

The U.S. is considering allowing bemotrizinol, a highly effective UV filter used throughout Europe and Asia, in its sunscreen products for the first time ...

Dec 2 (Reuters) - The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical toxicity studies for certain monoclonal antibodies.

Former US public health officials are sounding alarms about significant changes being made to the country’s vaccine policy under the Trump administration.

As the U.S. works several levers to lower drug pricing, such as Medicare negotiating costs with drugmakers and President Donald Trump launching TrumpRx, a report from the IQVIA Institute ...

The U.S. Food and Drug Administration announced it is reviewing a proposal to allow bemotrizinol in sunscreens sold in the United States.

Against a backdrop of tariff updates and a drug pricing deal from the Trump administration, the FDA charted a pair of moves this week in its push to make drug manufacturing more attractive in ...

The U.S. Food and Drug Administration said on Monday it has granted a national priority voucher to Johnson & Johnson's blood ...