A coalition of ALS patients and caregivers is petitioning the FDA to review available data on the stem cell therapy NurOwn ...

New PDUFA Action Date of December 13, 2025 $75 Million Royalty Purchase Agreement Payment from RTW Extended Through 2025 MONTREAL and CHARLOTTE, N.C., July 11, 2025 (GLOBE NEWSWIRE) -- Milestone® Phar ...

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

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 ...

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

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

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

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

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

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 ...

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 ...