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

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

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 ...

Publix has had to manage several recalls involving both meat and non-meat products since the start of the year.

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

A long-acting flea and tick treatment from Merck Animal Health has earned approval for dogs at least six months old from the ...

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