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  4. 2024 Biological License Application Supplement Noteworthy Approvals
  1. Development & Approval Process (CBER)

2024 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.

2024 Biological License Application Supplement Noteworthy Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License No.
Approval Date
ABRYSVO
Respiratory Syncytial Virus Vaccine
To update the ABRYSVO package insert to include the second efficacy and safety analyses (end of season one) from study C3671013, and seasonal inactivated influenza vaccine co-administration data from study C3671006. 125769/3 Pfizer Inc.
66 Hudson Blvd East,
New York, NY 10001

Lic. # 2001
08/30/2024
ACAM2000
Smallpox and Mpox (Vaccinia) Vaccine, Live
To include prevention of mpox disease in individuals determined to be at high risk for mpox infection. 125158/297 Emergent Product Development Gaithersburg Inc.
3500 N. Martin Luther King Jr. Blvd
Lansing, MI 48906-9910

Lic. # 2089
08/29/2024
MACI
autologous cultured chondrocytes on porcine collagen membrane
For the addition of arthroscopic delivery of MACI to the U.S. Package Insert (USPI) Section 2, Dosage and Administration. 125603/576 Vericel Corporation
64 Sidney Street
Cambridge, MA 02139

Lic. # 2010
08/23/2024
AREXVY
Respiratory Syncytial Virus Vaccine, Adjuvanted
To include data on the durability of the efficacy of AREXVY against Respiratory Syncytial Virus (RSV) associated lower respiratory tract disease over two RSV seasons following administration of a single dose. 125775/98 GlaxoSmithKline Biologicals
14200 Shady Grove Road
Rockville, MD 20850-7464

Lic. # 1617
08/21/2024
BEXSERO
Meningococcal Group B Vaccine
To include data from the confirmatory clinical study conducted to verify and describe the clinical benefit of BEXSERO. The BEXSERO dosing schedule has been revised in individuals 10 through 25 years of age from two doses administered at 0 and ≥1 month to two doses administered at 0 and 6 months, and to include a three-dose schedule of BEXSERO administered at 0, 1-2, and 6 months for the same age group. 125546/1058 GlaxoSmithKline Biologicals
14200 Shady Grove Road
Rockville, MD 20850-7464

Lic. # 1617
08/19/2024
FIBRYGA
Fibrinogen (Human)
To include the fibrinogen supplementation in bleeding adult and pediatric patients with acquired fibrinogen deficiency indication, and to update the US prescribing information to expand the indication to include fibrinogen supplementation in bleeding adult and pediatric patients with acquired fibrinogen deficiency indication. 125612/133 OCTAPHARMA Pharmazeutika Produktionsges.m.b.H.
117 West Century Road
Paramus, NJ 07652

Lic. # 1646
7/31/2024
PALFORZIA
Peanut (Arachis hypogaea) Allergen Powder-dnfp
To expand the age indication to include patients 1 through 3 years of age with a confirmed diagnosis of peanut allergy. 125696/247 Aimmune Therapeutics, Inc.
1007 US Hwy 202/206, Bldg JR2
Bridgewater, NJ 08807

Lic. # 2109
7/26/2024
XEMBIFY
Immune Globulin Subcutaneous (Human)
To include: 1) biweekly dosing for Primary Humoral Immunodeficiency (PI) patients 2 years of age and older switching from either an intravenous immune globulin or subcutaneous immune globulin; 2) addition of loading and maintenance dosing for treatment-naïve PI patients 2 years of age and older; 3) an increase to the maximal subcutaneous infusion rate to 35 mL/hour/site for PI patients 10 years of age and older. 125683/265 Grifols Therapeutics LLC
8368 US 70 Bus Hwy West
Clayton, NC 27520

Lic. # 1871
7/18/2024
ELEVIDYS
delandistrogene moxeparvovec-rokl
To expand the approved indication to individuals at least 4 years of age for the treatment of Duchenne muscular dystrophy (DMD) in patients who are ambulatory and have a confirmed mutation in the DMD gene. 125781/34 Sarepta
Therapeutics, Inc.
215 First Street
Cambridge, MA
02142

Lic. # 2308
06/20/2024
AREXVY
Respiratory Syncytial Virus Vaccine, Adjuvanted
To include use in individuals 50 through 59 years of age who are at increased risk for Lower Respiratory Tract Disease (LRTD) caused by Respiratory Syncytial Virus (RSV). 125775/132 GlaxoSmithKline
Biologicals
14200 Shady
Grove Road
Rockville, MD
20850-7464

Lic. # 1617
06/07/2024
BREYANZI
lisocabtagene maraleucel
To add a new indication for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor. 125714/227 Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
P.O. Box 5326
Princeton, NJ
08543

Lic. # 2156
05/30/2024
BREYANZI
lisocabtagene maraleucel
To add a new indication for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy, according to the regulations for accelerated approval, 21 CFR 601.41. 125714/225 Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
303 Science Park Rd.
San Diego, CA
92121

Lic. # 2156
05/15/2024
ALTUVIIIO
antihemophilic factor (recombinant), Fc-VWF-XTEN fusion protein-ehtl
To update the ALTUVIIIO U.S. Package Insert (USPI) to include completed pediatric study results (EFC16295). 125771/136 Bioverativ Therapeutics, Inc.
55 Corporate Drive
Bridgewater, NJ
08807
Lic. # 2078
05/10/2024
CARVYKTI
ciltacabtagene autoleucel
To extend the indication based on the results of the CARTITUDE-4 clinical trial (NCT04181827) for treatment in lenalidomide-refractory participants, following 1 to 3 prior lines of therapy for multiple myeloma. This supplemental application also provides for a modification to the approved Risk Evaluation and Mitigation Strategy (REMS). 125746/74 Janssen Biotech, Inc.
Janssen Research & Development, LLC
920 US Highway 202
Raritan, NJ 08869

Lic. # 1864
04/05/2024
ABECMA
idecabtagene vicleucel
To include an indication for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. 125736/218 Celgene Corporation, a Bristol-Myers Squibb Company
3401 Princeton Pike
Lawrenceville, NJ 08648

Lic. # 2252
04/04/2024
IXINITY
Coagulation Factor
IX (Recombinant)
To fulfill the required pediatric assessment for coagulation factor IX (recombinant) per STN BL 125426/222, and to expand the label to include pediatric patients <12 years of age for the treatment of Hemophilia B based on the data derived from the PMR study. 125426/223 Medexus Pharma, Inc.
29 N Wacker Ave
Chicago, IL 60606

Lic. # 2220
03/22/2024
BREYANZI
lisocabtagene
maraleucel
To support a new indication in relapsed/ refractory chronic lymphocytic leukemia or small lymphocytic lymphoma in patients who have received at least two prior lines of therapy including a Bruton’s tyrosine kinase (BTK) inhibitor and a B-cell lymphoma-2 (BCL-2) inhibitor, according to the regulations for accelerated approval, 21 CFR 601.41. 125714/205 Juno Therapeutics,
Inc., a Bristol-
Myers Squibb
Company
1000 Dexter Ave.
N., Suite 1200
Seattle, WA 98109

Lic. # 2156
03/14/2024
FLUCELVAX
Influenza Vaccine
To include a trivalent influenza vaccine formulation FLUCELVAX for use in individuals 6 months of age and older. 125408/575 Seqirus Inc.
475 Green Oaks
Parkway
Holly Springs, NC
27540

Lic. # 2049
03/04/2024
GAMMAGARD LIQUID
Immune Globulin Infusion (Human)
To improve neuromuscular disability and impairment in adult patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). 125105/2023 Takeda Pharmaceuticals U.S.A., Inc.
650 E. Kendall Street
Cambridge, MA 02142

Lic. # 1898
01/26/2024
HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
For treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment in adults. 125402/885 Takeda Pharmaceuticals U.S.A., Inc.
650 E. Kendall Street
Cambridge, MA 02142

Lic. # 1898
01/12/2024

 

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