FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CELLULAR, TISSUE, AND GENE THERAPIES ADVISORY COMMITTEE; NOTICE OF MEETING; ESTABLISHMENT OF A PUBLIC DOCKET; REQUEST FOR COMMENTS-BIOLOGICS LICENSE APPLICATION (BLA) 125827, FROM REPLIMUNE, INC. FOR VUSOLIMOGENE ODERPAREPVEC

WASHINGTON, July 24 -- Food and Drug Administration has issued a notice called: Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Biologics License Application (BLA) 125827, From Replimune, Inc. for Vusolimogene Oderparepvec.

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 30, 2026. The amendment is being made to reflect a ...