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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.

7/11/2025Myelodysplastic Syndromes: Developing Drug and Biological Products for Treatment; Draft Guidance for Industry
7/10/2025July 9, 2025 Approval Letter - SPIKEVAX
7/7/2025July 1, 2025 Approval Letter - FLULAVAL
7/7/2025July 3, 2025 Approval Letter - MNEXSPIKE
7/3/2025July 1, 2025 Approval Letter - AFLURIA
7/3/2025May 23, 2025 Clinical Review Memo - MenQuadfi
7/3/2025May 21, 2025 Statistical Review - MenQuadfi
7/2/2025Complete List of Licensed Products and Establishments 
Update
7/2/2025Complete List of Substantially Equivalent 510(k) Device Applications 
Update
7/2/2025Complete List of Currently Approved Premarket Approvals (PMAs) 
Update
7/2/2025Complete List of Currently Approved NDA and ANDA Application Submissions 
Update
7/2/2025June 26, 2025 Approval Letter - KYMRIAH
7/2/2025July 1, 2025 Approval Letter - Flublok
7/2/2025July 1, 2025 Approval Letter - FLUAD
7/2/2025BK251233 - cobas HIV-1/HIV-2 Qualitative nucleic acid test for use on the cobas 5800/6800/8800 systems
7/2/2025July 1, 2025 Approval Letter - Fluzone and Fluzone High-Dose
7/2/2025July 1, 2025 Approval Letter - FLUCELVAX
7/2/2025Unique Device Identifier Requirements for Combination Products; Draft Guidance for Industry
7/1/2025July 1, 2025 Approval Letter - FluMist
6/30/2025June 27, 2025 Approval Letter - GAMMAGARD LIQUID
6/30/2025June 26, 2025 REMS Elimination Approval Letter – TECARTUS
6/30/2025June 26, 2025 REMS Elimination Approval Letter – YESCARTA
6/27/2025June 26, 2025 Approval Letter - TECARTUS
6/27/2025June 26, 2025 Approval Letter - YESCARTA
6/27/2025Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Guidance for Industry and Food and Drug Administration Staff
6/27/2025June 26, 2025 Approval Letter - ABECMA
6/26/2025FDA Eliminates Risk Evaluation and Mitigation Strategies (REMS) for Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
6/26/2025June 26, 2025 Approval Letter - CARVYKTI
6/25/2025June 25, 2025 Approval Letter - SPIKEVAX
6/25/2025BK251184 - DG Gel 8 Neutral card
6/25/2025BK251183 - Erytra
6/25/2025BK251182 - Erytra Eflexis
6/25/2025June 25, 2025 Approval Letter - COMIRNATY
6/25/2025FDA Approves Required Updated Warning in Labeling of mRNA COVID-19 Vaccines Regarding Myocarditis and Pericarditis Following Vaccination
6/24/2025FDA Investigating Deaths Due to Acute Liver Failure in Non-ambulatory Duchenne Muscular Dystrophy Patients Following ELEVIDYS
6/24/2025June 23, 2025 Approval Letter - FIBRYGA
6/23/2025BK241079 - Peripheral blood processing device for wound management
6/20/2025May 30, 2025 Summary Basis for Regulatory Action - MNEXSPIKE
6/20/2025June 17, 2025 Approval Letter - Anti-Human Globulin DG GEL 8 ANTI-IgG (Rabbit) - STN# 125445/74
6/18/2025May 14, 2025 Approval Letter - PRIVIGEN


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