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  1. News & Events (Biologics)

What’s New for Biologics

Latest News from the Center for Biologics Evaluation and Research at FDA

+Items related to biologics will be added to the top of the list as they are posted on the site.

12/27/2025February 26, 2026 Approval Letter - AUCATZYL
12/27/2025February 24, 2026 Clinical Memo - AUCATZYL
02/24/2026BK251292- NexSys PCS® Plasma Collection System with Persona Plus Technology
02/24/2026February 20, 2026 Approval Letter - Fluzone Southern Hemisphere and Fluzone High-Dose Southern Hemisphere
02/23/2026February 20, 2026 Approval Letter - BREYANZI
02/23/2026February 20, 2026 Approval Letter - COMIRNATY
02/23/2026Considerations for the use of the Plausible Mechanism Framework to Develop Individualized Therapies that Target Specific Genetic Conditions with Known Biological Cause; Draft Guidance for Industry
02/17/2026February 13, 2026 Approval Letter - SHINGRIX
02/17/2026BK251296- PUREGRAFT SYNC Adipose Filtration System
02/12/2026February 11, 2026 Approval Letter - OMISIRGE
02/12/2026February 5, 2026 Approval Letter - YESCARTA
02/12/2026January 27, 2026 Approval Letter - THYMOGLOBULIN
02/12/2026Vaccines and Related Biological Products Advisory Committee March 12, 2026 Meeting Announcement
02/11/2026February 10, 2026 Approval Letter - 0.8% RESOLVE Panels, A, B, and C
02/05/2026Computer Software Assurance for Production and Quality Management System Software; Guidance for Industry and Food and Drug Administration Staff
02/05/2026BK251168- Precise Cell Concentration System
02/04/2026Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff


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