2025 Biological License Application Approvals

ITVISMA onasemnogene abeparvovec-brve Indicated for the treatment of spinal muscular atrophy (SMA) in adult and pediatric patients 2 years of age and older with confirmed mutation in survival motor neuron 1 (SMN1) gene.125856/0 Novartis Gene Therapies, Inc. 2275 Half Day Road, Suite 300 Bannockburn, IL 60015 Lic. # 2250 11/24/2025Blood Grouping Reagent, Anti-s (Human/Murine Monoclonal)Indicated for in vitro detection of the s (MNS4) antigen on human red blood cells by direct agglutination 125855/0 The American National Red Cross 9851 Commerce Way Douglasville, GA 30135 Lic. # 0190 11/21/2025Blood Grouping Reagent, Anti-S (Human/Murine Monoclonal)Indicated for in vitro detection of the S (MNS3) antigen on human red blood cells by direct agglutination using the manual tube test.125854/0 The American National Red Cross 9851 Commerce Way Douglasville, GA 30135 Lic. # 0190 11/21/2025Blood Grouping Reagent, Anti-Jkb (Human/Murine Monoclonal)Indicated for in vitro detection of the Jkb (JK2) antigen on human red blood cells by direct agglutination using the manual tube test.125853/0 The American National Red Cross 9851 Commerce Way Douglasville, GA 30135 Lic. # 0190 11/21/2025Blood Grouping Reagent, Anti-Jka (Human/Murine MonoclonalIndicated for in vitro detection of the Jka (JK1) antigen on human red blood cells by direct agglutination using the manual tube test.125852/0 The American National Red Cross 9851 Commerce Way Douglasville, GA 30135 Lic. # 0190 11/21/2025Blood Grouping Reagent, Anti-k (Human/Murine Monoclonal) (IgG)Indicated for in vitro detection of the k (KEL2) antigen on human red blood cells by the Indirect Antiglobulin Test (IAT).125851/0 The American National Red Cross 9851 Commerce Way Douglasville, GA 30135 Lic. # 0190 11/21/2025Blood Grouping Reagent, Anti-c (Human/Murine Monoclonal) Indicated for in vitro detection of the c (RH4) antigen on human red blood cells by direct agglutination using the manual tube testing method.125850/0 The American National Red Cross 9851 Commerce Way Douglasville, GA 30135 Lic. # 0190 11/21/2025Blood Grouping Reagent, Anti-E (Human/Murine Monoclonal)Indicated for in vitro detection of the E (RH3) antigen on human red blood cells by direct agglutination using the manual tube testing method.125849/0 The American National Red Cross 9851 Commerce Way Douglasville, GA 30135 Lic. # 0190 11/21/2025Blood Grouping Reagent, Anti-C (Human/Murine Monoclonal) Indicated for in vitro detection of the C (RH2) antigen on human red blood cells by direct agglutination using the manual tube testing method. 125848/0 The American National Red Cross 9851 Commerce Way Douglasville, GA 30135 Lic. # 0190 11/21/2025QIVIGY immune globulin intravenous, human-kthm 10% solutionIndicated for the treatment of adults with primary humoral immunodeficiency.125822/0 Kedrion S.p.A. Parker Plaza 400 Kelby Street, 11th Floor Fort Lee, NJ 07024 Lic. # 1851 9/26/2025PAPZIMEOS zopapogene imadenovec-drbaIndicated for the treatment of adults with recurrent respiratory papillomatosis.125832/0 Precigen, Inc. 20358 Seneca Meadows Parkway Germantown, MD 20876 Lic. # 2364 8/14/2025MNEXSPIKE COVID-19 Vaccine, mRNAIndicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MNEXSPIKE is approved for use in individuals who have been previously vaccinated with any COVID-19 vaccine and 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-19.125835/0 Moderna TX, Inc. 325 Binney Street Cambridge, MA 02142 Lic. # 2256 5/30/2025NUVAXOVID COVID-19 Vaccine, AdjuvantedIndicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older. Additionally, COVID-19 Vaccine, Adjuvanted is indicated for individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.125817/0 Novavax Inc. 700 Quince Orchard Road Gaithersburg, MD 20878 Lic. # 2349 5/16/2025ZEVASKYN prademagene zamikeracelIndicated for treatment of wounds in adult and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB).125807/0Abeona Therapeutics, Inc. 6555 Carnegie Ave, 4th Floor Cleveland, OH 44103 Lic. # 232904/28/2025ENCELTO revakinagene taroretcel-lwey Indicated for the treatment of adults with idiopathic macular telangiectasia type 2 (MacTel).125798/0Neurotech Pharmaceuticals, Inc. 900 Highland Corporate Drive Building #1, Suite #101 Cumberland, RI 02864 Lic. # 232103/05/2025VIMKUNYA Chikungunya Vaccine, RecombinantIndicated for the prevention of disease caused by chikungunya virus in individuals 12 years of age and older.125820/0Bavarian Nordic A/S Bavarian Nordic, Inc. 1005 Slater Road, Suite 101 Durham, NC 27703 Lic. # 209602/14/2025PENMENVY Meningococcal Groups A, B, C, W, and Y VaccineIndicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age.125819/0GlaxoSmithKline Biologicals 14200 Shady Grove Road VR1500 Rockville, MD 20850-7464 Lic. # 161702/14/2025