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

The company said it was “surprised” by the decision, which followed the ouster of cell and gene therapy officials from the ...

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

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 is expected to release data from the phase 3 HOPE-3 trial in Q3'25, thus presenting a potential path ...

Happy Friday. Today, we talk about the stem cell fire sale at CIRM, and about the FDA’s move to release a limited batch of ...

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

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

Duchenne muscular dystrophy is the most common type of muscular dystrophy and one of the most severe. It’s caused by a recessive gene mutation on the X chromosome. About 1 in 3,500 males are ...

The U.S. Food and Drug Administration has declined to approve Capricor Therapeutics' cell therapy for a heart condition, the company said on Friday, sending its shares tumbling 30% in early trading.

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