deramiocel

Generic: allogeneic cardiosphere-derived cells (CDCs)

deramiocel: developed by 1 company · 4 FDA decisions. Updated within the last hour.

Development Pipeline (1)

FDA Decisions

FDA_MeetingFDA offered the Company the opportunity to request a Type A meeting to discuss the path forward following issuance of a Complete Response Letter.(CAPR)
CRLDuchenne muscular dystrophy ("DMD") cardiomyopathy(CAPR)
PDUFA(CAPR)
FDA_MeetingFDA accepted Capricor's BLA for deramiocel and granted Priority Review with PDUFA target action date of 2025-08-31.(CAPR)

Frequently asked questions

Who is developing deramiocel?

deramiocel is being developed by CAPRICOR THERAPEUTICS, INC..

What is deramiocel's latest FDA decision?

The most recent tracked FDA decision for deramiocel is FDA_Meeting for FDA offered the Company the opportunity to request a Type A meeting to discuss the path forward following issuance of a Complete Response Letter..

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    deramiocel — Drug Pipeline, Trials & FDA Status | BioSniper