Switzerland’s medical products authority has granted the first approval for a malaria medicine designed for small infants ...

There's little point in pouring hundreds of millions of dollars into creating a biosimilar if PBMs will refuse to cover it.

President Trump has threatened to slap a 200% tariff on foreign-made pharmaceuticals. That would roil the $200 billion-plus ...

The drug gained a following in some circles for its supposed ability to treat COVID-19 safely, something all major medical ...

The fact that lenacapavir will soon be available to patients is a testament to the strength of America's biopharmaceutical ...

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...

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

The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

Several bulk boxes of Ritz cracker sandwich sleeves were recalled by their manufacturer and the FDA. Some peanut ...

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...

Sam Kelly explains how Queen Victoria became a huge fan of drugs—and how she brought China to its knees because of it.