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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.

07/01/2026Expiration Date Extension for North American Coral Snake Antivenin (Micrurus fulvius) (Equine Origin) Lot CL6814 through December 31, 2026
07/01/2026BK261345- HIV Combo Next Assay
07/01/2026July 1, 2026 Approval Letter - TREGZI
06/30/2026June 29, 2026 Approval Letter - AREXVY
06/29/2026Important Information for Blood Establishments Regarding Ebola Disease and Blood Donation
06/29/2026Recommendations for Assessment of Blood Donor Eligibility, Donor Deferral and Blood Product Management in Response to Ebola Virus; Guidance for Industry
06/29/2026Cellular, Tissue, and Gene Therapies Advisory Committee Meeting Announcement
Date: July 29, 2026
06/24/2026BK261357- SeCore CDx HLA Sequencing System
06/24/2026Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry
Updated: June 24, 2026
06/23/2026Master Protocols for Drug and Biological Product Development; Draft Guidance for Industry
06/23/2026BK251252- MEDIFLY Maggots
06/23/2026User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
06/23/2026Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products; Draft Guidance for Industry
06/22/2026June 18, 2026 Approval Letter - THYMOGLOBULIN
06/22/2026BK261349- cobas® HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas® 5800/6800/8800 systems
06/18/2026CBER 2026 Orphan Approvals (new BLAs)
06/18/2026June 16, 2026 Approval Letter - ZOLGENSMA
06/18/2026June 17, 2026 Approval Letter - TECELRA
06/18/2026June 17, 2026 Approval Letter - CAPVAXIVE
06/18/2026June 17, 2026 Approval Letter - VAXNEUVANCE
06/17/2026June 16, 2026 Approval Letter - ITVISMA
06/17/2026June 15, 2026 Approval Letter - YESCARTA
06/17/2026June 16, 2026 Approval Letter - TECARTUS
06/16/2026June 15, 2026 Approval Letter - CASGEVY (125787)
06/15/2026June 10, 2026 Approval Letter - PROCLEIX WNV ASSAY, Procleix Ultrio Elite Assay and Procleix Babesia Assay
06/15/2026June 11, 2026 Approval Letter - HYQVIA 
06/12/2026June 12, 2026 Approval Letter - ODACTRA
06/10/2026

Public Webinar: FDA Review of Biologics License Applications for Blood and Source Plasma

Materials Added:

  • Recordings
  • Transcript
  • Slides
  • Questions and Answers
06/10/2026BK261333- Blood Product Questionnaire Module (v2.0.0)
06/05/2026BK251274- RegenBMC® (RegenKit®-THT®-BMC)
06/05/2026BK261335- LIAISON® MUREX HIV Ab/Ag HT; LIAISON®XL; LIAISON® diluteX
06/05/2026BK261315- ELUclear Elution Kit
06/05/2026June 4, 2026 Approval Letter - Elecsys Anti-HBc II
06/04/2026SOPP 8406: CBER Processing of PDUFA Application Payments
06/04/2026SOPP 8401.1: Issuance of and Review of Responses to Information Request Communications to Pending Applications
06/03/2026Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers; Draft Guidance for Industry
06/02/2026May 20, 2026 Safety Labeling Change Order and SLC Notification Letter - ADZYNMA
06/02/2026Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry
05/29/2026Frequently Asked Questions (FAQs): Electronic Submissions Program for CBER-Regulated Products
05/29/2026COVID-19 Vaccines (2026-2027 Formula) for Use in the United States Beginning in Fall 2026
05/28/2026BK261329- Erytra Eflexis


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