Featured News In April, the FDA granted approval to several innovative therapies, expanding treatment options across autoimmune, genetic, and oncologic conditions. Key approvals include Imaavy for generalized myasthenia gravis, Vanrafia for IgA nephropathy, and Zevaskyn, a gene therapy for recessive dystrophic epidermolysis bullosa. The agency also approved penpulimab-kcqx, a PD-1 inhibitor, for advanced nasopharyngeal carcinoma. Additionally, updated formulations of established drugs received clearance, including Atzumi, a nasal powder for acute migraine, Mezofy, an oral film formulation of aripiprazole for schizophrenia, and Jobevne, a biosimilar to Avastin (bevacizumab).
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New Drug Approvals The following drugs have recently been approved by the FDA. - Atzumi (dihydroergotamine mesylate) Nasal Powder
Date of Approval: April 30, 2025 Treatment for: Migraine Press Release | Approval History
- Zevaskyn (prademagene zamikeracel) Gene-Modified Cellular Sheets
Date of Approval: April 29, 2025 Treatment for: Epidermolysis Bullosa Press Release | Approval History
- Imaavy (nipocalimab-aahu) Injection
Date of Approval: April 29, 2025 Treatment for: Myasthenia Gravis Press Release | Approval History
- penpulimab-kcqx Injection
Date of Approval: April 23, 2025 Treatment for: Nasopharyngeal Carcinoma Press Release | Approval History
- Mezofy (aripiprazole) Oral Film
Date of Approval: April 15, 2025 Treatment for: Schizophrenia Press Release | Approval History
- Jobevne (bevacizumab-nwgd) Injection
Date of Approval: April 9, 2025 Treatment for: Colorectal Cancer, Non Small Cell Lung Cancer, Glioblastoma Multiforme, Renal Cell Carcinoma, Cervical Cancer, Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer Press Release | Approval History
- Vanrafia (atrasentan) Tablets
Date of Approval: April 2, 2025 Treatment for: Immunoglobulin A Nephropathy Press Release | Approval History
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New Indications and Dosage Forms Drugs that have gained FDA approval for the treatment of additional diseases/conditions or new dosage forms/regimens. - Tryvio (aprocitentan) Tablets
Approval: April 2, 2025 Now Approved: Updated Label Removing the REMS Requirement Press Release | Approval History
- Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) Injection
Approval: April 10, 2025 Now Approved: Prefilled Syringe for Self-Injection Press Release | Approval History
- Yuflyma (adalimumab-aaty) Injection
Approval: April 7, 2025 Now Approved: Interchangeability Designation Press Release | Approval History
- Camzyos (mavacamten) Capsules
Approval: April 17, 2025 Now Approved: Revised Label Reducing Echocardiography Monitoring Requirements and Contraindications Press Release | Approval History
- Livmarli (maralixibat) Oral Solution and Tablets
Approval: April 14, 2025 Now Approved: Tablet Formulation Press Release | Approval History
- Uplizna (inebilizumab-cdon) Injection
Approval: April 3, 2025 Now Approved for: Immunoglobulin G4-Related Disease Press Release | Approval History
- Isturisa (osilodrostat) Tablets
Approval: April 15, 2025 Now Approved for: Endogenous Hypercortisolemia in Patients with Cushing’s Syndrome Press Release | Approval History
- Valtoco (diazepam) Nasal Spray
Approval: April 16, 2025 Now Approved for: Use in Pediatric Patients Ages 2 to 5 Years Press Release | Approval History
- Rinvoq (upadacitinib) Extended-Release Tablets
Approval: April 28, 2025 Now Approved for: Giant Cell Arteritis Press Release | Approval History
- Vitrakvi (larotrectinib) Capsules and Oral Solution
Approval: April 9, 2025 Now Approved: Full Approval for Use in NTRK Gene Fusion-Positive Solid Tumors Press Release | Approval History
- Dupixent (dupilumab) Injection
Approval: April 17, 2025 Now Approved for: Chronic Spontaneous Urticaria Press Release | Approval History
- Opdivo (nivolumab) Injection
Approval: April 11, 2025 Now Approved for: Opdivo+Yervoy for First-Line Treatment for Unresectable or Metastatic Hepatocellular Carcinoma Press Release | Approval History
- Opdivo (nivolumab) Injection
Approval: April 8, 2025 Now Approved: Opdivo+Yervoy for First-Line Treatment of MSI-H or dMMR Colorectal Cancer Press Release | Approval History
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First-Time Generic Approvals First Time Generics are those drug products that have never been approved before as generic drug products and are new generic products to the marketplace.
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This information is not intended to be medical advice. You should contact your physician before making any changes to your health care. Drugs.com is not responsible for content provided by third-party websites. The Editorial Team, Drugs.com
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