The White House is set to announce drug pricing deals with pharmaceutical heavyweights Novartis AG and Roche Holding AG as ...

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

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 treatment for severe asthma, offering a less frequently dosed option, but ...

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 ...

Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

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.

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 ...

The FDA has revealed a set of measures designed to increase the availability of biosimilars in the U.S. and in turn reduce the price of biologic medicines after they lose patent protection. In new ...

Sun Pharmaceutical Industries Ltd announced that its Baska manufacturing facility has been classified as Official Action ...