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.

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

Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.

The company expects to make the updated Spikevax available to U.S. patients in time for the 2025-26 respiratory virus season.

The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

To mark his first 100 days as head of the FDA, Martin Makary is touting his efforts to change the agency’s operations. The Food and Drug Administration ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...