The U.S. health regulator has approved GSK's add-on drug to treat severe asthma, the drugmaker said on Tuesday, paving the way for a less frequently dosed treatment option for patients to enter the market.

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

Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental weight‑loss pill, after the company pushed for a faster timeline, documents seen by show.

The U.S. Food and Drug Administration said on Monday it has granted a national priority voucher to Johnson & Johnson's blood cancer treatment, bringing the total number of products receiving an award under the new program to 16 this year.

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 concerns raised by vaccine skeptics,

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

The U.S. health regulator on Friday approved Innoviva's oral antibiotic to treat gonorrhea, a common sexually transmitted infection, offering patients an alternative to an injectable drug that was the only recommended treatment until now.

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. Friday, the regulator unveiled a new pilot ...

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 quantified how much more the U.S. pays for medications. IQVIA, a ...

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

The U.S. Food and Drug Administration has approved Flow Neuroscience's at-home brain stimulation device to treat depression, offering an alternative to typical antidepressants that can cause side effects with long-term use,