2026 Biological License Application Supplement Noteworthy Approvals
This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License No. | Approval Date |
|---|---|---|---|---|
Immune Globulin Intravenous, Human-slra | To fulfill the required pediatric assessment for ASCENIV per STN BL 125590/0, and to expand the label to include pediatric patients 2 to 11 years of age for the treatment of primary humoral immunodeficiency, based on the data from the pediatric study ADMA-004. | 125590/190 | ADMA Biologics 5800 Park of Commerce Boulevard, N.W. Lic. # 2019 | 04/30/2026 |
etranacogene dezaparvovec-drlb | To update the US Prescribing Information to reflect the updated efficacy and safety profile of HEMGENIX following the completion of the CSL222_3001 study. | 125772/242 | CSL Behring LLC 1020 First Avenue Lic. # 1767 | 04/29/2026 |
Influenza A [H5N1] Virus Monovalent Vaccine, Adjuvanted | To update the influenza virus strain from A/Indonesia/05/2005 (H5N1) to A/Astrakhan/3212/2020-like (H5N8, clade 2.3.4.4b) for use in individuals 6 months of age and older at increased risk of exposure to the influenza A virus H5 subtype contained in the vaccine and to include associated labeling revisions. Use of AREPANRIX containing the influenza virus strain A/Astrakhan/3212/2020-like (H5N8, clade 2.3.4.4b) in individuals 6 months through 17 years of age is approved according to the regulations for accelerated approval, 21 CFR 601.41. | 125419/166 | ID Biomedical Corporation of Quebec GlaxoSmithKline Biologicals Lic. # 1739 | 04/28/2026 |
Ebola Zaire Vaccine, Live | To update the package insert to include safety and immunogenicity data from the Phase 2 study, V920-15, that evaluated the safety and immunogenicity of ERVEBO in HIV-infected adults and adolescents. | 125690/97 | Merck Sharp & Dohme LLC 351 N. Sumneytown Pike | 04/20/2026 |
brexucabtagene autoleucel | To include the completed accelerated approval required study (ZUMA-2) final report for PMR #2 in the approval letter issued on July 24, 2020 for BLA STN 125703/0 to convert from an accelerated to a traditional approval for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) with revisions to sections 1 INDICATIONS AND USAGE, 2 DOSAGE AND ADMINISTRATION, 5 WARNINGS AND PRECAUTIONS, 6 ADVERSE REACTIONS, 12 CLINICAL PHARMACOLOGY, 14 CLINICAL STUDIES and MEDICATION GUIDE in the prescribing information label. | 125703/464 | Kite Pharma, Inc. 2400 Broadway Lic. # 2064 | 04/01/2026 |
Syncytial Virus Vaccine, Adjuvanted | To include use in individuals 18 through 49 years of age who are at increased risk for Lower Respiratory Tract Disease (LRTD) caused by Respiratory Syncytial Virus (RSV) and associated labeling changes including the addition of a Limitations of Use statement to the Package Insert and the Carton Label. | 125775/414 | GlaxoSmithKline Biologicals 2400 Broadway Santa Monica, CA 90404 Lic. # 1617 | 03/12/2026 |
| COMIRNATY COVID-19 Vaccine, mRNA | To revise the Package Insert to include information in Section 8 Use in Specific Populations from Study C4591015 of COMIRNATY administered during pregnancy (with the first dose at 24 to 34 weeks gestation) and from Study C4591024 of COMIRNATY administered to immunocompromised individuals 5 years of age and older. | 125742/684 | BioNTech Manufacturing GmbH Pfizer, Inc. 66 Hudson Boulevard East New York, NY 10001 Lic. # 2229 | 02/20/2026 |
| BREYANZI lisocabtagene maraleucel | To fulfill the BL 125714/225 accelerated approval required study, final milestone, and to provide evidence of effectiveness necessary to support the conversion from an accelerated approval to a traditional approval of lisocabtagene maraleucel for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. | 125714/703 | Juno Therapeutics, Inc., a Bristol-Myers Squibb Company 556 Morris Avenue Summit, NJ 07901 Lic. # 2156 | 02/20/2026 |
| SHINGRIX Zoster Vaccine Recombinant, Adjuvanted | To include revisions to the Package Insert as follows:
| 125614/1206 | GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7640 Lic. # 1617 | 02/13/2026 |
| YESCARTA axicabtagene ciloleucel | The supplement revises United States Prescribing Information (USPI) as follows: Section 1 (Indication and Usage) removes the Limitations of Use for Primary Central Nervous System Lymphoma (PCNSL); Section 5 (Warnings and Precautions) adds neurological toxicities identified from the new clinical study; Section 6 (Adverse Reactions) incorporates study information and adverse reactions from the new clinical study; and Section 12.3 (Pharmacokinetics) adds pharmacokinetics data from the new clinical study. | 125643/753 | Kite Pharma, Inc. 2400 Broadway Santa Monica, CA 90404 Lic. # 2064 | 02/05/2026 |