U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  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.

8/1/2022 Complete List of Licensed Products and Establishments
8/1/2022 Complete List of Substantially Equivalent 510(k) Device Applications
8/1/2022 Complete List of Currently Approved Premarket Approvals (PMAs)
8/1/2022 Complete List of Currently Approved NDA and ANDA Application Submissions
8/1/2022 Changes to Disposable Manufacturing Materials: Questions and Answers; Guidance for Industry
7/28/2022 BK220669 - NEO Iris
7/28/2022 BK220670 - Galileo NEO
7/28/2022 Exceptions and Alternative Procedures Approved Under 21 CFR 640.120(a)
7/28/2022 July 14, 2022 Summary Basis for Regulatory Action -Alinity s Anti-HCV II assay
7/27/2022 July 27, 2022 Approval Letter - FluMist
7/27/2022 July 8, 2022 Clinical Review Memo - COMIRNATY
7/27/2022 Statistical Review - COMIRNATY
7/27/2022 July 27, 2022 Approval Letter - ActHIB
7/27/2022 July 26, 2022 Approval Letter - Blood Grouping Reagents (Monoclonal) Anti-S, Anti-s and Anti-Fya (IgG)
7/27/2022 July 26, 2022 Approval Letter - Blood Grouping Reagent, Anti-k (Monoclonal)
7/27/2022 July 26, 2022 Approval Letter - Blood Grouping Reagent, Anti-Fyb (Monoclonal)
7/25/2022 CBER Vacancy: Principal Investigator - Biomedical Engineering
7/22/2022 July 21, 2022 Approval Letter - DAPTACEL
7/22/2022 Annual Patient Engagement & Regenerative Medicine Meeting 2022: An FDA CBER Workshop for Patient Advocates
7/22/2022 July 21, 2022 Approval Letter - Pentacel
7/22/2022 July 21, 2022 Approval Letter - Quadracel
7/21/2022 Clinical Investigator Status (Biologics)
7/18/2022 BK210584 - Genesis RapidWeld II STW, model GRW-430-02
7/15/2022 July 15, 2022 Approval Letter - Alinity s Anti-HCV II assay
7/15/2022 July 8, 2022 Summary of Safety and Effectiveness Data - Alinity m HIV-1
7/13/2022 July 8, 2022 Approval Order – Alinity m HIV-1
7/11/2021 BK210661 - RegenKit-Wound Gel-2
7/8/2022 July 8, 2022 Approval Letter - COMIRNATY
7/7/2022 May 26, 2022 Clinical Memo - KYMRIAH
7/7/2022 April 1, 2022 Statistical Review - KYMRIAH
7/6/2022 June 30, 2022 Approval Letter (Replacement) - IMLYGIC
7/6/2022 June 14, 2022 Approval Letter - IMLYGIC
7/6/2022 Influenza Vaccine for the 2022-2023 Season
7/6/2022 Seasonal Information for Influenza Virus Vaccine
7/5/2022 July 1, 2022 Approval Letter - FLUARIX QUADRIVALENT
7/5/2022 Cumulative CBER Regenerative Medicine Advanced Therapy (RMAT) Designation Requests Received by Fiscal Year
7/5/2022 CBER Regenerative Medicine Advanced Therapy (RMAT) Approvals
7/5/2022 CBER Regenerative Medicine Advanced Therapy (RMAT) Designations Withdrawn after Granting or Rescinded by Fiscal Year
7/5/2022 July 1, 2022 Approval Letter - Fluzone Quadrivalent and Fluzone High-Dose Quadrivalent
7/5/2022 July 1, 2022 Approval Letter - Afluria and Afluria Quadrivalent 
7/5/2022 July 1, 2022 Approval Letter - Flublok Quadrivalent
7/5/2022 July 1, 2022 Approval Letter - Flucelvax Quadrivalent 
7/5/2022 July 1, 2022 Approval Letter - FLUAD QUADRIVALENT
7/5/2022 July 1, 2022 Approval Letter - FluLaval Quadrivalent

 



Back to Top