Capricor Therapeutics Inc. shares plunged more than 60% after US regulators rejected the company’s treatment for a deadly ...

“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...

FDA Commissioner Marty Makary suggests his agency may expedite drug reviews for manufacturers reducing U.S. prices to global ...

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

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

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

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

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 ...

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.

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