FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: 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)

WASHINGTON, July 24 -- Food and Drug Administration has issued a notice called: 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).

The notice was published in the Federal Register on July 24 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

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 Registeron June 29, 2026. The amendment is being made to reflect a change in the DATES, ADDR...