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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.

03/19/2026Pyrogen and Endotoxins Testing: Questions and Answers; Guidance for Industry
3/18/2026March 12, 2026 Approval Letter - Quadracel  
3/18/2026March 12, 2026 Approval Letter - Pentacel  
03/18/2026Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma
Webinar Date: May 12, 2026
03/17/2026March 6, 2026 Approval Letter - Elecsys Anti-HCV II
03/17/2026March 16, 2026 Approval Letter - Procleix Plasmodium Assay
03/17/2026SOPP 8215: Management of Regenerative Medicine Advanced Therapy Products: Request for Designation, Sponsor Interactions, and Status Assessment
03/16/2025March 12, 2026 Approval Letter - VAXELIS
03/16/2026SOPP 8412: Review of Product Labeling
03/16/2026March 13, 2026 Approval Letter - RotaTeq
03/16/2026BK251299- PlateletQuick PRP
03/13/2026Influenza Vaccine Composition for the 2026-2027 U.S. Influenza Season
03/13/2026March 12, 2026 Approval Letter - AREXVY
03/13/2026SOPP 8401.2: Administrative Processing of BLA and NDA Supplements
03/12/2026Patient and Consumer Warning about Potential Serious Risks of Harm following Use of Unapproved Products from Human Cells or Tissues
Safety Communication
03/11/2026February 20, 2026 Clinical Review Memo - BREYANZI
03/11/2026BK251294- Hemanext ONE
03/10/2026October 8, 2024 Approval Letter - PROCLEIX WNV ASSAY
03/10/2026March 4, 2025 Approval Letter - Alinity s HTLV I/II
03/10/2026June 7, 2024 Approval Letter - Alinity s HBsAg and Alinity s HBsAg Confirmatory
03/10/2026March 28, 2024 Approval Letter  - cobas® TaqScreen WNV Test
03/10/2026January 8, 2025 - Approval Letter Alinity s Anti-HBc assay
03/09/2026March 6, 2026 Approval Letter - Standardized Bermuda Grass (Cynodon dactylon) Grass Pollen
03/09/2026SOPP 8110: Submission of Regulatory Applications -- Exempt from eCTD Requirements
03/09/2026Questions and Answers on Biosimilar Development and the BPCI Act; Guidance for Industry
03/06/2026February 17, 2026 Approval Letter - Elecsys HBsAg II
03/06/2026Responding to FDA Form 483 Observations at the Conclusion of a Drug CGMP Inspection; Draft Guidance for Industry
03/04/2026Advancing Pediatric Cell and Gene Therapy Clinical Trials: Scientific, Ethical, Regulatory, and Practical Considerations
Workshop Date: April 9, 2026
03/03/2026BK251232- PRF-Matrix System
03/02/2026February 25, 2026 Approval Letter - PAPZIMEOS
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


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