It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...

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

The U.S. Food and Drug Administration has granted full approval for Moderna's COVID-19 vaccine, Spikevax, in children aged 6 ...

A member of Columbia University's Board of Trustees is calling on the school to comply with the Trump administration's ...

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

A wave of menopause-related legislation has been introduced across the United States this year, leading to possible shifts in ...

In discussions with multiple potential animal health company partners to collaborate to bring Canalevia®, conditionally ...

Prices are falling for the popular obesity treatments Wegovy and Zepbound, but steady access to the drugs remains challenging ...

In addition to finding these dyes in brightly colored processed foods, the researchers also found them in more muted foods ...

Florida’s importation program hasn’t brought in a single Canadian drug. It’s not cost-effective and it could be dangerous.

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

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