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

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

Quest will offer the first FDA-approved blood test to help detect Alzheimer’s-related amyloid pathology in patients 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 ...

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 ...

Several food items sold in vending machines throughout Ohio, northern Kentucky, and eastern Indiana are being recalled due to an undeclared Sesame allergen, according to the U.S. Food and Drug ...

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.