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 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.

3/31/2025BK231039 - Giotto Monza (BCS03)
3/27/2025March 26, 2025 Approval Letter - Blood Grouping Reagents and Anti-Human Globulin Reagents - Seraclone - Anti-D (RH1) Blend
3/26/2025March 5, 2025 Summary Basis for Regulatory Action - ENCELTO
3/26/2025March 25, 2025 Approval Letter - GARDASIL 9
3/24/2025March 21, 2025 Approval Letter - SHINGRIX
3/13/2025Influenza Vaccine Composition for the 2025-2026 U.S. Influenza Season
3/10/2025Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
2/28/2025FDA Plans for Selecting Influenza Virus Strains for Vaccine Composition for the 2025-2026 U.S. Influenza Season
2/19/2025Cell Therapies and Tissue-Based Products: A Public Workshop on Generating Scientific Evidence to Facilitate Development
February 25, 2025 - Agenda added


Back to Top