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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.

04/29/2026April 28, 2026 Approval Letter - AREPANRIX
04/29/2026April 28, 2026 Approval Letter - GAMUNEX-C
04/27/2026Vaccines and Related Biological Products Advisory Committee Meeting Announcement
Date: May 28, 2026
04/23/2026April 23, 2026 Approval Letter - OTARMENI
04/23/2026April 22, 2026 Approval Letter - VIMKUNYA
04/23/2026Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry
04/21/2026April 20, 2026 Approval Letter - ERVEBO
04/21/2026March 31, 2026 Approval Letter - Elecsys HIV Duo
04/15/2026Pediatric Tracking Requirements Under FDAAA
04/15/2026March 26, 2026 Summary Basis for Regulatory Action - KRESLADI
04/14/2026Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry
04/10/2026April 10, 2026 Approval Letter - THROMBIN-JMI LIQUID
04/10/2026SOPP 8001.4: Review of Proprietary Names for CBER Regulated Products
04/09/2026SOPP 8216: Fast Track Development Programs - Designation and Management
04/09/2026SOPP 8212: Breakthrough Therapy Products - Designation and Management
04/07/2026April 1, 2026 Approval Letter - Profilnine SD - Factor IX Complex
04/03/2026BK251289- Plasmacell-C Disposable Set
04/02/2026April 1, 2026 Approval Letter - TECARTUS
04/02/2026SOPP 8404.1: Procedures for Filing an Application When the Applicant Protests a Refusal to File Action (File Over Protest)
04/02/2026Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff
03/30/2026March 27, 2026 Approval Letter - PRIORIX
03/27/2026BK251300- Procleix Plasmodium Quality Control
03/27/2026March 26, 2026 Approval Letter - KRESLADI


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