What's New at CBER 07/02/2026

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What's New Today

The following links have been updated recently:

Posted: 07/02/2026

July 1, 2026 Approval Letter - Flublok

July 1, 2026 Approval Letter - CASGEVY

July 1, 2026 Approval Letter - FLUCELVAX

July 1, 2026 Approval Letter - FLULAVAL

July 1, 2026 Approval Letter - Fluzone and Fluzone High-Dose

July 1, 2026 Approval Letter - FLUAD

Recently Published Guidance

Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing, Draft Guidance
- Comment Period Open Through July 14, 2026
Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing, Draft Guidance
- Comment Period Open Through September 1, 2026
Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application
- For Immediate Implementation

Upcoming Meetings

July 29, 2026 | 10:00 a.m. - 04:30 p.m. ET
Cellular, Tissue, and Gene Therapies Advisory Committee Meeting

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