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FDA and Capricor clash over deramiocel efficacy data at Duchenne adcomm vote
FDA and Capricor spar over HOPE-3 data at an adcomm for a Duchenne cell therapy, as The Lancet publishes results and families back the cell therapy.
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statnews.com
Ahead of hearing, FDA questions the efficacy of Capricor's Duchenne drug
Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
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medpagetoday.com
FDA Scientists Raise Questions About Duchenne Drug
Agency says deramiocel did not meet phase III trial endpoints, contrary to reported data
