Featured News September FDA approvals included Genentech’s Ocrevus Zunovo for multiple sclerosis, AstraZeneca’s Tagrisso for lung cancer and Filspari to slow kidney function decline. Johnson & Johnson’s Tremfya is cleared for ulcerative colitis and Miplyffa and Aqneursa are OK’d for ultra-rare Niemann-Pick disease type C. Other approvals include: Bristol Myers Squibb’s oral Cobenfy for schizophrenia, Eli Lilly’s Ebglyss injection for atopic dermatitis, ready-to-use Boruzu (bortezomib), and FluMist nasal flu vaccine for self or caregiver administration.
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New Drug Approvals The following drugs have recently been approved by the FDA. - Flyrcado (flurpiridaz F 18) Injection
Date of Approval: September 27, 2024 Treatment for: Positron Emission Tomography Imaging Press Release | Approval History
- Otulfi (ustekinumab-aauz) Injection
Date of Approval: September 27, 2024 Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis Press Release | Approval History
- Cobenfy (xanomeline and trospium chloride) Capsules
Date of Approval: September 26, 2024 Treatment for: Schizophrenia Press Release | Approval History
- Aqneursa (levacetylleucine) Granules for Oral Suspension
Date of Approval: September 24, 2024 Treatment for: Niemann-Pick Disease Press Release | Approval History
- Miplyffa (arimoclomol) Capsules
Date of Approval: September 20, 2024 Treatment for: Niemann-Pick Disease Press Release | Approval History
- Ebglyss (lebrikizumab-lbkz) injection
Date of Approval: September 13, 2024 Treatment for: Atopic Dermatitis Press Release | Approval History
- Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq) Injection
Date of Approval: September 13, 2024 Treatment for: Multiple Sclerosis Press Release | Approval History
- Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) Injection
Date of Approval: September 12, 2024 Treatment for: Press Release | Approval History
- Boruzu (bortezomib) Injection
Date of Approval: September 5, 2024 Treatment for: Multiple Myeloma, Mantle Cell Lymphoma 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. - Bimzelx (bimekizumab-bkzx) Injection
Approval: September 20, 2024 Now Approved for Psoriatic Arthritis, Non-Radiographic Axial Spondyloarthritis and Ankylosing Spondylitis Press Release | Approval History
- Filspari (sparsentan) Tablets
Approval: September 5, 2024 Now Approved: Full FDA Approval for IgA Nephropathy Press Release | Approval History
- Rybrevant (amivantamab-vmjw) Injection
Approval: September 19, 2024 Now Approved: in Combination With Chemotherapy for Patients with EGFR Mutated Non-Small Cell Lung Cancer Whose Disease has Progressed Press Release | Approval History
- Retevmo (selpercatinib) Capsules and Tablets
Approval: September 27, 2024 Now Approved: Traditional Approval for Medullary Thyroid Cancer with a RET Mutation Press Release | Approval History
- Sarclisa (isatuximab-irfc) Injection
Approval: September 20, 2024 Now Approved: in Combination with Standard-of-Care Treatment for Adult Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Transplant Press Release | Approval History
- Fasenra (benralizumab) Injection
Approval: September 17, 2024 Now Approved for: Eosinophilic Granulomatosis with Polyangiitis Press Release | Approval History
- Tremfya (guselkumab) Injection
Approval: September 11, 2024 Now Approved for: Ulcerative Colitis Press Release | Approval History
- Dupixent (dupilumab) Injection
Approval: September 12, 2024 Now Approved for: Adolescents 12 Years of Age and Older with Chronic Rhinosinusitis with Nasal Polyps Press Release | Approval History
- Dupixent (dupilumab) Injection
Approval: September 27, 2024 Now Approved for: Chronic Obstructive Pulmonary Disease (COPD) Press Release | Approval History
- Kisqali (ribociclib) Tablets
Approval: September 17, 2024 Now Approved to: Reduce Risk of Recurrence in People with HR+/HER2- Early Breast Cancer Press Release | Approval History
- Tagrisso (osimertinib) Tablets
Approval: September 25, 2024 Now Approved for: Unresectable, Stage III EGFR-Mutated Non-Small Cell Lung Cancer Press Release | Approval History
- Keytruda (pembrolizumab) for Injection
Approval: September 17, 2024 Now Approved for: Malignant Pleural Mesothelioma Press Release | Approval History
- FluMist (Influenza Virus Vaccine, Live, Intranasal) Nasal Spray
Approval: September 20, 2024 Now Approved for: Self-Administration 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. - Drospirenone Tablets
4 mg
Approved: September 30, 2024 - Lupin Ltd.
Treatment for: Prevention of Pregnancy
Generic for:
Slynd
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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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