Under the accelerated pathway, the FDA mandates additional trials that verify the drug's benefits. If the data from the ...

Costco customers with dairy allergies may need to check their fridge because 80,000 pounds of the retailer's butter was ...

Jaguar Health announced that its product, cofelemer delayed-release tablets (Canalevia-CA1; Jaguar Health), received approved ...

The FDA is in a unique position with RFK Jr. potentially set to be given full control over the incoming administration’s health policies.

In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...

The FDA proposed a ban on phenylephrine, a common decongestant found in cold and cough medications. Here’s why and a list of ...

Set to become compulsory Nov. 20, the regulation isn't likely to make pharma ads easier for consumers to comprehend, but ...

The products are part of the agency's ongoing public health alert concerning cinnamon with elevated lead levels ...

For those families ready to throw them away after having the test for only one month, the US Food and Drug Administration ...

The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s ...

Johnson & Johnson MedTech has received a go-ahead from the FDA to begin human clinical trials of its Ottava surgical robot, ...