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

Capricor Therapeutics shares plummeted in premarket trading Friday after the U.S. Food and Drug Administration turned away the biotechnology company's bid for approval of Deramiocel, its lead ...

Capricor Therapeutics (NASDAQ:CAPR) shares fell Friday after the company announced it received a complete response letter from the U.S. Food and Drug Administration for its Biologics License ...

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 ...

Amarna Therapeutics and NorthX Biologics finalized an agreement to advance Nimvec AM510 gene therapy toward clinical trials for Type 1 Diabetes. Now in its fourth year, the MM+M Media Summit brings ...

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

Ophthalmology Times connects eye care professionals with surgery, imaging, gene therapy, & diagnostic advances to enhance ...

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.

Florida’s importation program hasn’t brought in a single Canadian drug. It’s not cost-effective and it could be dangerous.

To mark his first 100 days as head of the FDA, Martin Makary is touting his efforts to change the agency’s operations. The Food and Drug Administration ...

The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...