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

“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 ...

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 ...

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

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

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

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

Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...

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

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