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

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

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

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

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.

Capricor Therapeutics (NASDAQ:CAPR) saw its stock plummet by 53% on Friday after the U.S. Food and Drug Administration issued a Complete Response Letter (CRL), rejecting the company’s bid for approval ...

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

TAS-205 showed no significant impact on motor function in patients with Duchenne muscular dystrophy (DMD), highlighting the ongoing search for effective treatments for the rare condition.

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

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 ...

Taiho Pharmaceutical has suffered a blow to its near-term pipeline after a drug candidate for Duchenne muscular dystrophy ...