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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.

09/02/2026SOPP 8203: Administrative Processing and Review Management of Charging Requests (Cost Recovery Requests) for Investigational New Drugs and Investigational Devices
09/02/2026August 19, 2026 Summary Basis for Regulatory Action - GENGLYCOS
08/28/2026SOPP 8421: Complying with Requirements under the Pediatric Research Equity Act (PREA) & Best Pharmaceuticals for Children Act (BPCA)
08/28/2026August 5, 2026 Summary Basis for Regulatory Action - MFLUSIVA
08/28/2026FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing
Meeting agenda updated
08/27/2026August 27, 2026 Approval Letter - NUVAXOVID
08/27/2026August 27, 2027 Approval Letter - SPIKEVAX
08/27/2026August 27, 2026 Approval Letter - MNEXSPIKE
08/27/2026August 26, 2026 - Approval Letter - DAPTACEL
08/27/2026FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing
Updated
08/27/2026August 26, 2026 - Approval Letter - TENIVAC
08/27/2026August 26, 2026 - Approval Letter - Adacel
08/26/2026FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics
Updated
08/26/2026Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry
Comment Period Open Through September 1, 2026
08/26/2026Potency Assessment of Active Immunotherapy Products; Draft Guidance of Industry
Comment Period Open Through November 18, 2026
08/21/2026BK251307- Donor Information System Version 9.0
08/21/2026BK251308- Biowy Multi-Chamber Freezing Bag
08/21/2026SOPP 8005: Formal Dispute Resolution Process
08/20/2026August 19, 2026 Approval Letter - GENGLYCOS
08/19/2026April 29, 2026 Clinical and Clinical Pharmacology Review Memo - ASCENIV
08/19/2026Statistical Review - ASCENIV (125590/190)
08/19/2026August 4, 2026 Approval Letter - ELEVIDYS
08/19/2026Frequently Asked Questions — Developing Potential Cellular and Gene Therapy Products; Guidance for Industry
08/18/2026June 18, 2026 Clinical Review Memo - CAPVAXIVE
08/18/2026June 18, 2026 Statistical Review Memo - CAPVAXIVE
08/18/2026August 14, 2026 Approval Letter - DUCORD
08/18/2026FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing
Draft agenda added
08/18/2026June 29, 2026 Summary Basis for Regulatory Action - EZPLAZ
08/14/2026Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
08/13/2026Container Closure Systems for Human Drugs and Biological Products; Draft Guidance for Industry
08/13/2026August 6, 2026 Summary Basis for Regulatory Action - TUDRIQEV
08/12/2026Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products; Guidance for Industry
08/10/2026August 7, 2026 Approval Letter - MRESVIA
08/07/2026August 6, 2026 Approval Letter - YESCARTA
08/06/2026August 6, 2026 Approval Letter - TUDRIQEV
08/06/2026August 5, 2026 Approval Letter - MFLUSIVA
08/06/2026FDA Scientific Public Workshop: Next-Generation Sequencing for Adventitious Agent Detection in Biologics
Draft agenda added
08/03/2026Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance of Industry
Updated: August 3, 2026


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