2026 Meeting Materials, Cellular, Tissue, and Gene Therapies Advisory Committee
July 30, 2026
The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002.
The public will also have the option to participate via an online teleconferencing and/or video conferencing platform, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.
On July 30, 2026, the Committee will meet in open session to discuss and make recommendations on Biologics License Application (BLA) 125827, from Replimune, Inc. for vusolimogene oderparepvec. The proposed indication (use) is in combination with nivolumab for the treatment of adult patients with advanced melanoma who have previously received an anti-PD-1 containing regimen.
July 29, 2026
The meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-0002.
The public will also have the option to participate via an online teleconferencing and/or video conferencing platform, and the advisory committee meeting will be heard, viewed, captioned, and recorded through an online teleconferencing and/or video conferencing platform.
On July 29, 2026, the Committee will meet in open session to discuss and make recommendations on Biologics License Application (BLA) 125842 from Capricor, Inc. for deramiocel (human allogeneic cardiosphere-derived cells) the treatment of cardiomyopathy in Duchenne muscular dystrophy (DMD).