In a bid to increase transparency, the U.S. Food and Drug Administration has begun publishing the complete response letters ...

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

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

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 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.

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

The Whole Herb Company Inc. issued a voluntary recall for select lots of its organic whole celery seeds on May 27 due to potential salmonella contamination.

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

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

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

KalVista Pharmaceuticals said on Monday the U.S. Food and Drug Administration has approved its drug, the first on-demand oral treatment for a type of hereditary swelling disorder, sending its shares ...

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