U.S. flag An official website of the United States government
  1. Home
  2. Vaccines, Blood & Biologics
  3. News & Events (Biologics)
  4. What’s New for Biologics
  1. News & Events (Biologics)

What’s New for Biologics

Latest news from the Center for Biologics and Evaluation at FDA.

Items related to biologics will be added to the top of the list as they are posted on the site.

6/17/2021 June 15, 2021 Untitled Letter - NatureWorks P.S.
6/17/2021 June 4, 2021 Summary Basis for Regulatory Action - RYPLAZIM
6/16/2021 June 14, 2021 Approval Letter - ADYNOVATE
6/15/2021 June 15, 2021 Approval Letter - STRATAGRAFT
6/14/2021 June 11, 2021 Approval Letter - KYMRIAH
6/10/2021 June 10, 2021 Approval Letter - PREVNAR 20
06/10/2021 CBER-Regulated Products: Resolved Shortages
06/9/2021 Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2021
6/8/2021 Urgent Voluntary Notification: FiberCel Fiber Viable Bone Matrix (“FiberCel”) - Lot Number: NMDS210011
6/8/2021 eSubmitter Application History
6/7/2021 June 7, 2021 Approval Letter - JYNNEOS
6/7/2021 June 4, 2021 Approval Letter - RIASTAP
6/4/2021 June 4, 2021 Approval Letter - RYPLAZIM
6/4/2021 Regulatory Education for Industry (REdI) Annual Conference 2021
6/3/2021 Preclinical Pharm-Tox Review - KEDRAB
6/3/2021 Clinical Review Memo - KEDRAB
6/3/2021 Statistical Review Memo -KEDRAB
6/3/2021 Important Patient and Consumer Information About Regenerative Medicine Therapies
6/2/2021 BK210559 - Sysmex XN-10 Automated Hematology Analyzer
6/2/2021 CBER Expanded Access Submission Receipt Reports
6/1/2021 Complete List of Licensed Products and Establishments
6/1/2021 Complete List of Substantially Equivalent 510(k) Device Applications
6/1/2021 Complete List of Currently Approved Premarket Approvals (PMAs)
6/1/2021 Complete List of Currently Approved NDA and ANDA Application Submissions
5/28/2021 Model Informed Drug Development Approaches for Immunogenicity Assessments
5/28/2021 Model Informed Drug Development Approaches for Immunogenicity Assessments Agenda
5/26/2021 CBER-Regulated Products: Current Shortages
5/25/2021 Emergency Use Authorization for Vaccines to Prevent COVID-19; Guidance for Industry
5/21/2021 HCT/P Inspection Information
5/21/2021 Vaccines and Related Biological Products Advisory Committee June 10, 2021 Meeting Announcement
5/20/2021 2021 Biological License Application Supplement Noteworthy Approvals
5/20/2021 2021 Biological Device Application Approvals
5/19/2021 May 17, 2021 Approval Letter - KEDRAB
5/18/2021 Exceptions and Alternative Procedures Approved Under 21 CFR 640.120
5/17/2021 BK210564 - ORTHO VISION Max Analyzer
5/17/2021 BK210557 - ORTHO VISION Analyzer
5/12/2021 Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays
5/12/2021 Information for Blood Establishments Regarding FDA’s Determination that Zika Virus is no Longer a Relevant Transfusion-Transmitted Infection, and Withdrawal of Guidance titled “Revised Recommendations for Reducing the Risk of Zika Virus Transmission by Blood and Blood Components”
5/11/2021 April 2, 2021 Approval Letter - YESCARTA
5/11/2021 eSubmitter Application History

 



Back to Top