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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.

05/19/2026BK261326- Viality™ Lipoaspirate Wash System for Aesthetic Body Contouring (Viality-1400)
05/19/2026BK261331- ORTHO Optix™ Reader
05/19/2026Postapproval Pregnancy Safety Studies; Guidance for Industry
05/18/2026May 15, 2026 Approval Letter - RotaTeq
05/15/2026May 14, 2026 Approval Letter - PEDIARIX
05/15/2026May 14, 2026 Approval Letter - TWINRIX
05/15/2026May 14, 2026 Approval Letter - INFANRIX
05/15/2026May 14, 2026 Approval Letter - KINRIX
05/15/2026May 14, 2026 Approval Letter - BOOSTRIX
05/15/2026May 14, 2026 Approval Letter - HAVRIX
05/15/2026Submitting Continuous Glucose Monitoring Data in Clinical Trials; Guidance for Industry
05/08/2026SOPP 8301: Receipt and Processing of Master Files
05/07/2026March 19, 2026 Approval Letter - DUCORD
05/07/2026SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)
05/07/2026April 22, 2026 Summary Basis for Regulatory Action - OTARMENI
05/05/2026Chemistry, Manufacturing, and Controls Flexibilities for Developing Human Cellular and Gene Therapy Products for a Biologics License Application; Guidance for Industry
05/05/2026BK261343- Biowy Multi-Chamber Freezing Bag Set
05/04/2026April 30, 2026 Approval Letter - ASCENIV
05/01/2026April 30, 2026 Approval Letter - ROTARIX
05/01/2026April 30, 2026 Approval Letter - AREXVY
04/30/2026April 29, 2026 Approval Letter - HEMGENIX
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


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