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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.

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08/03/2026Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance of Industry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
7/31/2026July 31, 2026 Approval Letter - Alphanate
7/31/2026July 30, 2026 Approval Letter - ADACEL
07/31/2026Biosimilar and Interchangeable Biosimilar Products: Considerations for Container Closure Systems and Device Constituent Parts; Draft Guidance for Industry
07/30/2026SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)
07/29/2026July 29, 2026 Approval Letter - EZPLAZ
07/28/2026July 27, 2026 Approval Letter - AREXVY
07/27/2026Cancer Clinical Trial Eligibility Criteria: Laboratory Values; Guidance for Industry, IRBs, and Clinical Investigators
07/27/2026Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications; Guidance for Industry, IRBs, and Clinical Investigators
07/27/2026Cancer Clinical Trial Eligibility Criteria: Performance Status; Guidance for Industry, IRBs, and Clinical Investigators
07/24/2026BK261351- ADAMII CD34 System
07/23/2026OTP Town Hall: Best Practices for Preparing BLA Submissions for Cell and Gene Therapy Products
Town Hall Transcript available
07/23/2026July 22, 2026 Approval Letter - FluMist
07/16/2026SOPP 8795: Posting and Announcement of Premarket Approval Application and Humanitarian Device Exemption Approvals and Denials
07/15/2026July 14, 2026 Approval Letter - HEXTEND HMW Hydroxyethel Starch (6%)
07/15/2026FDA Roundtable: Strengthening the Supply Chain for Blood Manufacturing
Date: September 29, 2026


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