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

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

MRK's $10B buyout of VRNA brings in Ohtuvayre, a unique COPD therapy set to bolster its cardio-pulmonary portfolio.

In the courtyard of Beijing's Xuannan Bookstore, an unusual art exhibition is quietly unfolding. Each painting features ...

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

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

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).

Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

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

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.

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