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 ...

Milestone Pharmaceuticals shares rose 18% in premarket trading after disclosing that the Food and Drug Administration accepted for review its response to issues raised in the complete response letter ...

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

The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...

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

FDA approves Bravecto Quantum, the first injectable flea and tick treatment offering dogs up to 12 months of protection.

The federal government's investigation into a recall of Salmonella-contaminated brown cage-free and certified-organic eggs ...

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.

Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.

The U.S. Food and Drug Administration (FDA) has issued a nationwide recall of several Ritz Cracker Sandwich products due to a ...

The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...

The Food and Drug Administration (FDA) is a government agency that is responsible for the promotion and protection of public health. The FDA was established when the Pure Food and Drugs Act was ...