FDA Panel Votes Against Capricor's Duchenne Cell Therapy Amid Statistical Confusion
Product·2 articles across 2 outlets
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An FDA advisory panel concluded clinical data for a Capricor treatment for Duchenne muscular dystrophy did not provide “substantial evidence” of efficacy.
The panel's decision followed a contentious meeting marked by statistical disputes, ultimately leading to a vote against Capricor’s cell therapy for the condition.
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SourceReports the news
“An FDA advisory panel concluded clinical data for a Capricor treatment for Duchenne muscular dystrophy did not provide “substantial evidence” of efficacy”
stat news — STAT+: Pharmalittle: We’re reading about an FDA panel nixing a Duchenne drug, FTC suing Hims & Hers, and more“At a contentious meeting with possible implications”
biopharma dive — Capricor Duchenne cell therapy voted down by FDA panel“A panel of experts today voted against Capricor’s cell therapy for Duchenne muscular dystrophy, capping off an advisory committee meeting marked by statistical confusion.”
fierce biotech — <a href="/biotech/fda-adcomm-shoots-down-capricors-duchenne-cell-therapy-after-meeting-marked-statistical" hreflang="en">FDA adcomm shoots down Capricor's Duchenne cell therapy after meeting marked by statistical dispute</a>