The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...

INDIANA- FDA advises consumers not to inhale nitrous oxide products from any size canisters, tanks, or chargers. These ...

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

A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...

To the chagrin of advocates and HHS, Mars is not making promises on banning artificial dyes like others in Big Food. What ...

Florida has strengthened its rules on then-packaging and marketing for "diet weed" hemp extract products like delta-8, delta-9, delta-10 or THC-O.

Capricor, which was seeking approval of Deramiocel for the treatment of cardiomyopathy associated with DMD, said the FDA issued a so-called complete response letter, indicating the agency won't ...

The FDA has approved a groundbreaking new therapy for patients battling late-stage melanoma, offering hope when options run out.

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 ...