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
Palo Alto, CA 94304

 

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: 

• 10 mcg drug product (2025-2026 Formula) in the single-dose vial presentation manufactured at the Pfizer, Puurs facility and associated labeling revisions, for use in individuals 5 years through 11 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19; and 
• 30 mcg drug product (2025-2026 Formula) in the single-dose prefilled syringe presentation manufactured at the Pfizer, Puurs facility 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.

125742/656

BioNTech Manufacturing GmbH 

Pfizer, Inc. 66 Hudson Boulevard East New York, NY 10001 
 

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

Lic. # 2256

7/9/2025

GAMMAGARD LIQUID ERC

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
U.S.A., Inc.

650 E. Kendall Street
Cambridge, MA 02142

Lic. # 1898

6/27/2025

MRESVIA

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
Cambridge, MA 02142

Lic. # 2256
 

6/12/2025

ABRYSVO

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
Collegeville, PA 19426

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.
Discovery Drive
Swiftwater, PA 18370-0187

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
14200 Shady Grove Road
Rockville, MD 20850-7464

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
100 Bayer Boulevard, P.O. Box 915
Whippany, NJ 07981-0915

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

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