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

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy ...

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising ...

Capricor Therapeutics (CAPR) on Friday said the U.S. Food and Drug Administration (FDA) has refused to approve its lead cell ...

The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.

US biotech Capricor Therapeutics today revealed receipt of a Complete Response Letter (CRL) from the US Food and Drug ...

Dyne Therapeutics, Inc. (NASDAQ:DYN) is one of the 13 Best Healthcare Stocks to Buy Under $10. In a report released on July 7 ...

Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy ...

FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...

FDA issued Complete Response Letter Capricor plans to resubmit its BLA to include data from the ongoing Phase 3 HOPE-3 trial ...

In total, 11 abstracts on givinostat were accepted for presentation at the Congress, including two for an oral presentation ...

Families caring for individuals with Duchenne muscular dystrophy (DMD) face significant financial burdens from necessary home ...