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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.

2/12/2025Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year 
Data as of December 31, 2024
2/12/2025CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year 
Data as of December 31, 2024
2/12/2025CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals 
Data as of December 31, 2024
1/17/2025CY 2024 Report from the Director
1/16/2025Thimerosal and Vaccines
1/16/2025December 18, 2024 Summary Basis for Regulatory Action - RYONCIL
1/15/2025BK231018 - AHC Platelet Concentrate Separator
1/15/2025BK241148 - cobas pro serology solution (applicable to)
a) Elecsys Syphilis and
b) Elecsys Anti-CMV
1/15/2025January 8, 2025 Summary Basis for Regulatory Action - Automated C3d Plate
1/15/2025BK210601 - Echo Lumena
1/15/2025BK210604 - Complement Control Cells
1/15/2025BK210608 - Galileo Echo
1/15/2025Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria; Draft Guidance for Industry
1/14/2025Artificial Intelligence and Machine Learning (AI/ML) for Biological and Other Products Regulated by CBER
1/13/2025Premarket Approval Application and Humanitarian Device Exemption Modular Review; Guidance for Industry and Food and Drug Administration Staff
1/13/2025Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act; Guidance for Industry and Food and Drug Administration Staff
1/13/2025Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Guidance for Industry and Food and Drug Administration Staff
1/10/2025December 19, 2024 Summary Basis for Regulatory Action - SYMVESS
1/10/2025Clinical Investigator Status (Biologics) 
Updated through 12/31/2024
1/10/2025January 8, 2025 Approval Letter - Automated C3d Plate
1/8/2025Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry and Other Interested Parties
1/8/2025WCBP 2025: The 29th Symposium on the Interface of Regulatory and Analytical Sciences for Biotechnology Health Products
January 28 - 30, 2025
1/8/2025Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers; Guidance for Industry
1/8/2025Considerations for Complying with 21 CFR 211.110; Draft Guidance for Industry
1/8/2025Study of Sex Differences in the Clinical Evaluation of Medical Products; Draft Guidance for Industry
1/7/2025January 6, 2025 Approval Letter - AREXVY
1/7/2025FDA Requires Guillain-Barré Syndrome (GBS) Warning in the Prescribing Information for RSV Vaccines Abrysvo and Arexvy
1/7/2025January 6, 2025 Approval Letter - ABRYSVO (125769/388)
1/6/2025Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
1/6/2025Recommendations to Reduce the Risk of Transmission of Hepatitis B Virus (HBV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
1/6/2025Recommendations to Reduce the Risk of Transmission of Hepatitis C Virus (HCV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
1/6/2025Recommendations to Reduce the Risk of Transmission of Human Immunodeficiency Virus (HIV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry
1/6/2025Recommendations to Reduce the Risk of Transmission of Disease Agents Associated with Sepsis by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry
1/6/2025Recommendations to Reduce the Risk of Transmission of Mycobacterium tuberculosis (Mtb) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Guidance for Industry
1/6/2025BK241067 – MatchX
1/3/2025December 18, 2024 Clinical Pharmacology Memorandum - NUWIQ
1/3/2025Combined Food and Drug Administration and Sponsor Oncologic Drugs Advisory Committee Briefing Document; Draft Guidance for Industry
1/2/2025Complete List of Licensed Products and Establishments 
Update
1/2/2025Complete List of Substantially Equivalent 510(k) Device Applications 
Update
1/2/2025Complete List of Currently Approved Premarket Approvals (PMAs) 
Update
1/2/2025Complete List of Currently Approved NDA and ANDA Application Submissions 
Update
1/2/2025SOPP 8422: Processing and Review of Trans-BLA Submissions
1/2/2025Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2025
12/31/2024Advanced Manufacturing Technologies Designation Program; Guidance for Industry
12/27/2024Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices; Draft Guidance for Industry
12/26/2024December 23, 2024 Approval Letter - MRESVIA


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