Federal Register #FDA-2026-N-7231

FDA Amends Advisory Committee Meeting Notice for Replimune's Vusolimogene Oderparepvec

This notice is an administrative update from the Food and Drug Administration (FDA) regarding the Cellular, Tissue, and Gene Therapies Advisory Committee meeting. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Focus of Meeting: - Discussion of Biologics License Application (BLA) 125827 - Product under review: Vusolimogene Oderparepvec - Applicant: Replimune, Inc. - Amendment Details: - Updates to meeting date, location, and procedures - Information on public participation and oral presentations - Establishment of a public docket for comments - No procurement or contract award is involved - No products or services are being requested or purchased

Description

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 meeting focuses on the Biologics License Application (BLA) 125827 from Replimune, Inc. for Vusolimogene Oderparepvec. The amendment updates the meeting date, location, and procedure details, including public participation options and oral presentation scheduling. The meeting will be held on July 30, 2026, with online public viewing available.

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