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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.

11/07/2025November 7, 2025 Approval Letter - Measles, Mumps, and Rubella Virus Vaccine Live
11/07/2025October 29, 2025 Approval Letter - Elecsys HTLV-I/II
11/6/2025November 5, 2025 Approval Letter - CYFENDUS
11/6/2025September 26, 2025 Chair Review Memorandum - MNEXSPIKE
11/6/2025November 5, 2025 Approval Letter - BioThrax
11/4/2025BK251238 - ORTHO VISION® Analyzer and ORTHO VISION® Max Analyzer
10/31/2025SOPP 8117: Issuing Tracking Numbers in Advance of Electronic Submissions in eCTD Format
10/29/2025Scientific Considerations in Demonstrating Biosimilarity to a Reference Product: Updated Recommendations for Assessing the Need for Comparative Efficacy Studies; Draft Guidance for Industry
10/29/2025Quality Management System Information for Certain Premarket Submission Reviews; Draft Guidance for Industry and Food and Drug Administration Staff
10/29/2025October 21, 2025 Approval Letter - TECARTUS
10/28/2025BK251256 - ImmuLINK (v3.3)
10/28/2025October 21, 2025 Approval Letter - YESCARTA
10/24/2025Immune Globulin Intravenous (IGIV) and/or Immune Globulin Subcutaneous (IGSC) Lots with Increased Reports of Allergic/Hypersensitivity Reactions
10/24/2025BK251237 -DAT Control (MTSTM DAT Card)
10/24/2025October 23, 2025 Approval Letter - Elecsys Chagas
10/23/2025Expanded Access to Investigational Drugs for Treatment Use: Questions and Answers; Guidance for Industry
10/23/2025October 10, 2025 Approval Letter - Anti-C3b,-C3d (Murine Monoclonal)/DAT Control, MTS DAT Card
10/22/2025Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders
10/22/2025October 9, 2025 Summary of Safety and Effectiveness Data (SSED) - INSTI HIV Self Test
10/21/2025Approval of New Patch Tests for the Diagnosis of Allergic Contact Dermatitis; Public Workshop
Workshop Agenda Updated
10/21/2025BK251280 - cobas pro serology solution (applicable to) Elecsys Syphilis and Elecsys Anti-CMV
10/15/2025October 10, 2025 Approval Letter - ADYNOVATE
10/15/2025September 26, 2025 Summary Basis for Regulatory Action - QIVIGY
10/15/2025September 15, 2025 Clinical Review Memo - Whole Blood and Components Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived)
10/15/2025SOPP 8001.2: Accessing the FDA Lists of Disqualified and Restricted Clinical Investigators, Debarred Individuals, and Firms Under the FDA Application Integrity Policy
10/14/2025October 10, 2025 Approval Letter - Whole Blood and Components Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived)
10/14/2025BK251201 - DR.PRP-30
10/10/2025October 10, 2025 Approval Letter - CARVYKTI
10/10/2025October 9, 2025 Approval Letter - INSTI HIV Self Test
10/10/2025FDA approves labeling changes that include a Boxed Warning for Immune Effector Cell-associated Enterocolitis following treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)
10/10/2025October 9, 2025 Approval Letter - ADSTILADRIN
10/08/2025BK251157 - ENDORET® Kit
10/1/2025September 30, 2025 Approval Letter - ARTISS
10/1/2025September 30, 2025 Approval Letter - TISSEEL


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