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HHS · Notice · Rel 100 (Federal Register (major agencies))

Cellular, Tissue, and Gene Therapies Advisory Committee; Amendment of Notice-Biologics License Application (BLA) 125842 From Capricor, Inc. for Deramiocel (Human Allogeneic Cardiosphere-Derived Cells)

Other · Health / life sciences · general, public-health, fda-guidance

Source summary

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Cellular, Tissue, and Gene Therapies Advisory Committee (the Committee). This meeting was announced in the Federal Register on June 29, 2026. The amendment is being made to reflect a change in the DATES, ADDRESSES, and SUPPLEMENTARY INFORMATION: Procedure portion of the document. There are no other changes.

Analyst note

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