US EditionCapricor plans for deramiocel resubmission after FDA rejection
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Capricor plans for deramiocel resubmission after FDA rejection
Capricor Therapeutics will resubmit its application for U.S. Food and Drug Administration (FDA) approval of its cell therapy deramiocel to treat Duchenne muscular dystrophy (DMD)-related heart disease, following the agency’s decision to not accept the original filing. According to a company press release, the FDA issued a complete response letter (CRL) requesting additional clinical data, stating that the initial submission did not sufficiently …
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