GSK Plc said it won US approval for a drug to treat severe asthma, boosting its prospects as a potential blockbuster.

The U.S. health regulator has approved GSK's add-on drug to treat severe asthma, the drugmaker said on Tuesday, paving the ...

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

The U.S. health regulator on Friday approved Innoviva's oral antibiotic to treat gonorrhea, a common sexually transmitted ...

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

The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger and Albertsons after some of the stores failed to remove recalled baby formula linked to a large infant botulism ...

Food and Drug Administration have pressed internally for reviewers to speed up their evaluation of Eli Lilly's experimental ...

Walmart, Target, Kroger and Albertsons kept the ‌recalled ByHeart Whole Nutrition Infant Formula on store shelves even after ...

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

(Bloomberg) -- Americans spend more on prescription drugs than anyone else in the world. It’s true that they take a lot of pills. But what really sets the US apart is how much drugs cost. Unlike in ...