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

The agency disclosed a tranche of more than 200 complete response letters from the past five years, but only those involving medicines that it later cleared.

If approved, doravirine/islatravir would be the first two-drug HIV treatment regimen without an integrase inhibitor, ...

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.

Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...

Used for diagnosing gastroesophageal reflux, the devices may not attach or detach correctly, potentially causing serious ...

The US Food and Drug Administration has started making rejection letters that pharmaceutical companies traditionally keep ...

FDA researchers report that the upper end of reported consumer use (~400mg of daily CBD intake) of cannabidiol (CBD) may ...

A growing disconnect remains between what generics are approved and what are actually accessible, GoodRx said.

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 U.S. FDA has approved a new test for patients with lung cancer to match the correct individuals with a targeted treatment ...

The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...