Merilog (insulin aspart-szjj) Injection
Company: Sanofi Date of Approval: February 14, 2025 Treatment for: Diabetes Mellitus
Merilog (insulin aspart-szjj) is a rapid acting human insulin analog biosimilar to NovoLog (insulin aspart) indicated to improve glycemic control in adults and pediatric patients with diabetes mellitus.
- FDA Approves Merilog (insulin-aspart-szjj), a Biosimilar to NovoLog – February 16, 2025
- Merilog FDA Approval History
Vimkunya (chikungunya vaccine, recombinant) Injection
Company: Bavarian Nordic A/S Date of Approval: February 14, 2025 Treatment for: Chikungunya Disease Prevention
Vimkunya (chikungunya vaccine, recombinant) is a vaccine used for the prevention of disease caused by chikungunya virus.
- FDA Approves Vimkunya (chikungunya vaccine, recombinant) for Prevention of Disease Caused by Chikungunya Virus – February 14, 2025
- Vimkunya FDA Approval History
Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) Lyophilized Powder for Injection
Company: GlaxoSmithKline Date of Approval: February 14, 2025 Treatment for: Meningococcal Disease Prophylaxis
Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) is a vaccine indicated 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.
- FDA Approves Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) for Prevention of Invasive Meningococcal Disease Caused by Serogroups A, B, C, W, and Y – February 15, 2025
- Penmenvy FDA Approval History
Romvimza (vimseltinib) Capsules
Company: Deciphera Pharmaceuticals, Inc. Date of Approval: February 14, 2025 Treatment for: Tenosynovial Giant Cell Tumor
Romvimza (vimseltinib) is a switch-control kinase inhibitor of colony stimulating factor 1 receptor (CSF1R) for the treatment of patients with tenosynovial giant cell tumor.
- FDA Approves Romvimza (vimseltinib) for the Treatment of Symptomatic Tenosynovial Giant Cell Tumor – February 14, 2025
- Romvimza FDA Approval History
Ctexli (chenodiol) Tablets
Company: Mirum Pharmaceuticals Inc. Date of Approval: February 21, 2025 Treatment for: Cerebrotendinous Xanthomatosis
Ctexli (chenodiol) is a synthetic form of the bile acid chenodeoxycholic acid indicated for the treatment of cerebrotendinous xanthomatosis in adults.
- FDA Approves Ctexli (chenodiol) for Cerebrotendinous Xanthomatosis – February 24, 2025
- Ctexli FDA Approval History
Miudella (copper) Intrauterine System
Company: Sebela Pharmaceuticals, Inc. Date of Approval: February 24, 2025 Treatment for: Birth Control
Miudella is a copper-containing intrauterine device (IUD) indicated for prevention of pregnancy in females of reproductive potential for up to 3 years.
- FDA Approves Miudella (copper intrauterine system) for the Prevention of Pregnancy – February 24, 2025
- Miudella FDA Approval History
Osenvelt (denosumab-bmwo) Injection – formerly CT-P41
Company: Celltrion USA Date of Approval: February 28, 2025 Treatment for: Osteolytic Bone Lesions of Multiple Myeloma, Osteolytic Bone Metastases of Solid Tumors, Giant Cell Tumor of Bone, Hypercalcemia of Malignancy
Osenvelt (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor biosimilar to Xgeva (denosumab) for use in the prevention of skeletal-related events in patients with multiple myeloma or bone metastases from solid tumors, treatment of giant cell tumor of bone, and treatment of hypercalcemia of malignancy.
- FDA Approves Osenvelt (denosumab-bmwo), a Biosimilar to Xgeva – March 3, 2025
- Osenvelt FDA Approval History
Stoboclo (denosumab-bmwo) Injection – formerly CT-P41
Company: Celltrion USA Date of Approval: February 28, 2025 Treatment for: Osteoporosis
Stoboclo (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor biosimilar to Prolia (denosumab) used in the treatment of osteoporosis.
- FDA Approves Stoboclo (denosumab-bmwo), a Biosimilar to Prolia – March 3, 2025
- Stoboclo FDA Approval History
Encelto (revakinagene taroretcel-lwey) Intravitreal Implant – formerly NT-501
Company: Neurotech Pharmaceuticals, Inc. Date of Approval: March 5, 2025 Treatment for: Macular Telangiectasia Type 2
Encelto (revakinagene taroretcel-lwey) is an allogeneic encapsulated cell-based gene therapy indicated for the treatment of adults with idiopathic macular telangiectasia type 2.
- FDA Approves Encelto (revakinagene taroretcel-lwey) for the Treatment of Macular Telangiectasia Type 2 (MacTel) – March 6, 2025
- Encelto FDA Approval History
Omlyclo (omalizumab-igec) Injection
Company: Celltrion USA Date of Approval: March 7, 2025 Treatment for: Asthma, Maintenance, Chronic Rhinosinusitis With Nasal Polyps, Food Allergies, Urticaria
Omlyclo (omalizumab-igec) is an anti-IgE antibody interchangeable biosimilar to Xolair for the treatment of asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and urticaria.
- FDA Approves Omlyclo (omalizumab-igec), an Interchangeable Biosimilar to Xolair – March 7, 2025
- Omlyclo FDA Approval History
