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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.

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)
06/10/2026Safety Assessment of Genome Editing in Human Gene Therapy Products Using Next-Generation Sequencing; Draft Guidance for Industry
Updated: June 10, 2026
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and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers; Draft Guidance for Industry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06/02/2026Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing; Draft Guidance for Industry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
05/22/2026Vaccines and Related Biological Products Advisory Committee Meeting Announcement
Date: June 18, 2026
05/22/2026SOPP 8412: Review of Product Labeling
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


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