FDA Commissioner Marty Makary said the agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost ...

The U.S. Food and Drug Administration has approved Bravecto Quantum, a new shot that protects dogs six months or older ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and unnecessary delays in the regulatory process.

A long-acting flea and tick treatment from Merck Animal Health has earned approval for dogs at least six months old from the Food and Drug Administration (FDA).

MRK's regulatory filing for once-daily HIV pill DOR/ISL gets FDA acceptance, with a decision expected by April 2026.

The main patent for Ohtuvayre, the COPD drug at the heart of Verona’s $10 billion sale, expired in 2020. For Merck to make ...

When the FDA unexpectedly uploaded around 200 drug rejection letters this week, the regulator provided a rare glimpse in | ...

FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...

The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

Rahway: Merck, known as MSD outside of the United States and Canada, has announced that the U.S. Food and Drug Administration ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

The FDA published more than 200 letters that it sent to companies when it rejected their medicines, but the letters came with a caveat.