2025 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 |
|---|---|---|---|---|
Respiratory Syncytial Virus Vaine
| To update the package insert with data from C3671023 Substudy B on ABRYSVO administration in immunocompromised adults aged 18 years and older. | 125769/421
| Pfizer Inc. 500 Arcola Road Lic. # 2001 | 12/19/2025 |
omidubicel-onlv | To include an additional indication, for the treatment of adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning. | 125738/69 | Gamida Cell Ltd. --(b)(4)-- ----------------------- ------------ -------------------- -------- Lic. # 2223 | 12/05/2025 |
lisocabtagene maraleucel | To add a new indication for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy, and to update the harmonized CD4+ Drug Product Component Specification for --(b)(4)---------------------- and ---(b)(4)-------------- -------------. | 125714/644 | Juno Therapeutics, Inc. a Bristol-Myers Squibb 556 Morris Avenue Lic. # 2156 | 12/04/2025 |
ciltacabtagene autoleucel | To include results from a protocol-specified second interim analysis from CARTITUDE-4. The supplement revises the Boxed Warning, Section 5 (Warnings and Precautions), Section 6 (Adverse Reactions), and the Medication Guide to include the risk of immune effector cell-associated enterocolitis, T cell lymphoma of the gastrointestinal tract, and gastrointestinal perforation. Additionally, the supplement revises Section 14 (Clinical Studies) of the USPI to include a protocol-specified analysis for overall survival from CARTITUDE-4. | 125746/249 | Janssen Biotech, Inc. 920 US Highway 202, P.O. Box 300 Lic. # 1864 | 10/10/2025 |
| Whole Blood and Blood Components (Convalescent Plasma, High Titer, Anti-SARS-CoV-2 (Whole Blood-derived) | Treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment. | 125396/21 | Stanford Blood Center 3373 Hillview Avenue
| 10/10/2025 |
| VYJUVEK beremagene geperpavec-svdt | Expand the indication to treat wounds in adults and pediatric patients (0 to 16 years of age) with dystrophic epidermolysis bullosa, and to allow application of VYJUVEK in home setting by a healthcare professional, patient or caregiver. | 125774/89 | Krystal Biotech, Inc. 2100 Wharton Street Suite 701 Pittsburgh, PA 15203 Lic. # 2301 | 9/12/2025 |
| VONVENDI von Willebrand Factor (Recombinant) | To expand the current approved adult prophylaxis indication for type 3 von Willebrand disease (VWD) to include adults with type 1 and type 2 VWD and to expand the use to pediatric patients with VWD for on demand treatment and control of bleeding episodes and perioperative management of bleeding. | 125577/691 | Takeda Pharmaceuticals USA, Inc 500 Kendall Street Cambridge, MA 02142 Lic. # 1898 | 9/5/2025 |
| NUVAXOVID COVID-19 Vaccine, Adjuvanted | To include the 2025-2026 Formula and associated labeling revisions. | 125817/6 | Novavax, Inc. 700 Quince Orchard Road Gaithersburg, MD 20878 Lic. # 2349 | 8/27/2025 |
| MNEXSPIKE COVID-19 Vaccine, mRNA | To include the 2025-2026 Formula and associated labeling revisions for use in individuals who are 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. | 125835/6 | ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 | 8/27/2025 |
| SPIKEVAX COVID-19 Vaccine, mRNA | To include the 2025-2026 Formula and associated labeling revisions. | 125752/305 | Moderna TX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 | 8/27/2025 |
| COMIRNATY COVID-19 Vaccine, mRNA | To include:
| 125742/656 | BioNTech Manufacturing GmbH Lic. # 2229 | 8/27/2025 |
| AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted | To include data on the safety and efficacy of AREXVY against Respiratory Syncytial Virus (RSV) associated lower respiratory tract disease in individuals 60 years of age and older over three RSV seasons following administration of a single dose. | 125775/297 | GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 1617 | 8/8/2025 |
| CAPVAXIVE Pneumococcal 21-valent Conjugate Vaccine | To update Section 8 "Use in Specific Populations", Section 6 “Clinical Trials Experience”, and Section 14 “Clinical Studies” of the package insert for the inclusion of individuals living with HIV (V116-007) and individuals at increased risk of pneumococcal disease (V116-008). | 125814/149 | Merck Sharp & Dohme LLC P.O. Box 1000 UG2D-68 North Wales, PA 19454-2505 Lic. # 0002 | 7/31/2025 |
| Imovax Rabies Rabies Vaccine | To update the package insert to include a 2-dose pre-exposure prophylaxis dosing regimen in addition to the currently approved 3-dose regimen. | 103931/5342 | Sanofi Pasteur SA Discovery Drive Swiftwater, PA 18370-0187 Lic. # 1724 | 7/24/2025 |
| SPIKEVAX COVID-19 Vaccine | To prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals who are 65 years of age and older, or 6 months through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and to include a new 0.25 mL pre-filled syringe presentation. | 125752/276 | ModernaTX, Inc. 325 Binney Street Cambridge, MA 02142 | 7/9/2025 |
Immune globulin infusion (human) 10% solution | For the indication of a replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older. | 125105/2184 | Takeda Pharmaceuticals 650 E. Kendall Street Lic. # 1898 | 6/27/2025 |
Respiratory Syncytial Virus Vaccine | To revise the indication and usage to include active immunization for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 18 through 59 years of age who are at increased risk for LRTD caused by RSV. | 125796/37 | ModernaTX, Inc. 325 Binney Street Lic. # 2256 | 6/12/2025 |
Respiratory Syncytial Virus Vaccine | To update the Package Insert to include safety and efficacy data from two full Respiratory Syncytial Virus (RSV) seasons from the Phase 3 clinical study C3671013, and the final safety data from the Phase 3 study C3671008. | 125769/277 | Pfizer Inc. 500 Arcola Road Lic. # 2001 | 6/9/2025 |
| MenQuadfi Meningococcal (Groups A, C, Y, W) Conjugate Vaccine | To update the Package Insert to include safety and effectiveness data from postmarketing requirement (PMR) studies MET41, MET42 and MET61 that support lowering the age for use to include individuals 6 weeks through 23 months of age. | 125701/262 | Sanofi Pasteur, Inc. Lic. # 1725 | 5/23/2025 |
| AREXVY Respiratory Syncytial Virus Vaccine, Adjuvanted | To update the Package Insert to include data from two clinical studies of concomitant administration of AREXVY with influenza vaccines in individuals 65 years of age and older. | 125775/247 | GlaxoSmithKline Biologicals Lic. # 1617 | 5/23/2025 |
| Jivi Antihemophilic Factor (recombinant), PEGylated-aucl | To revise the indication to include pediatric patients 7 to <12 years of age. | 125661/972 | Bayer HealthCare LLC Lic. # 0008 | 5/14/2025 |
| FluBlok Influenza Vaccine | To update the product labeling to include data and results from PREA PMR studies VAP00026 (3-8 year olds) and VAP00027 (9-17 and 18-49 year olds), and to use data from VAP00027 to support extending the Flublok indication to individuals 9 through 17 years of age, and to fulfill (PREA) PMR #1 and (PREA) PMR #2 (125285/471). | 125285/613 | Protein Sciences Corporation Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370 Lic. #1795 | 03/31/2025 |
| JYNNEOS Smallpox and Mpox Vaccine, Live, Non-replicating | To include a two-vial presentation of JYNNEOS that consists of a Lyophilized Antigen Component vial and a Diluent Component vial. | 125678/119 | Bavarian Nordic A/S Bavarian Nordic Inc. 1005 Slater Road, Suite 101 Durham, NC 27703 Lic. #2096 | 03/31/2025 |
| SHINGRIX Zoster Vaccine Recombinant, Adjuvanted | To update the US Prescribing Information to include information from Study Zoster-049 on long term effectiveness of SHINGRIX. | 125614/1022 | GlaxoSmithKline Biologicals 14200 Shady Grove Road Rockville, MD 20850-7464 Lic. #1617 | 03/21/2025 |
| ODACTRA House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract | To include use in children 5 through 11 years of age. | 125592/218 | ALK-Abello A/S ALK-Abello Inc. 135 Route 202/206 Suite 16 Bedminster, NJ 07921 Lic. #1292 | 02/27/2025 |
| Anti-Human Globulin | To replace the Anti-C3d used in MTS Anti-IgG, -C3d gel cards manufactured in Pompano Beach, Florida facility. | 103461/5123 | Micro Typing Systems, Inc. 100 Indigo Creek Drive Rochester, NY 14626 Lic. #1177 | 01/28/2025 |