Featured News In May, the FDA granted key approvals to treatments across the oncology autoimmune, and respiratory disease categories. Approvals include AbbVie’s Emrelis in non-small cell lung cancer, Avmapki Fakzynja Co-Pack in ovarian cancer, and GSK’s Nucala in chronic obstructive pulmonary disease. Other notable approvals are plaque psoriasis for Zoryve topical foam 0.3%, and Novavax’s Nuvaxovid (COVID-19 Vaccine, Adjuvanted) to prevent COVID-19. The FDA also approved Yutrepia, a novel prostacyclin analog inhalation powder for severe lung diseases and Alcon’s Tryptyr ophthalmic solution for dry eye disease.
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New Drug Approvals The following drugs have recently been approved by the FDA. - mNEXSPIKE (COVID-19 Vaccine, mRNA) Injection
Date of Approval: May 30, 2025 Treatment for: COVID-19 Press Release | Approval History
- Tryptyr (acoltremon) Ophthalmic Solution
Date of Approval: May 28, 2025 Treatment for: Dry Eye Disease Press Release | Approval History
- Khindivi (hydrocortisone) Oral Solution
Date of Approval: May 28, 2025 Treatment for: Adrenocortical Insufficiency Press Release | Approval History
- Yutrepia (treprostinil) Inhalation Powder
Date of Approval: May 23, 2025 Treatment for: Pulmonary Arterial Hypertension; Pulmonary Hypertension Associated with Interstitial Lung Disease Press Release | Approval History
- Starjemza (ustekinumab-hmny) Injection
Date of Approval: May 22, 2025 Treatment for: Plaque Psoriasis, Psoriatic Arthritis, Crohn's Disease, Ulcerative Colitis Press Release | Approval History
- Nuvaxovid (COVID-19 Vaccine, Adjuvanted) Injectable Suspension
Date of Approval: May 16, 2025 Treatment for: COVID-19 Press Release | Approval History
- Emrelis (telisotuzumab vedotin-tllv) Lyophilized Powder for Injection
Date of Approval: May 14, 2025 Treatment for: Non Small Cell Lung Cancer Press Release | Approval History
- Brekiya (dihydroergotamine mesylate) Injection
Date of Approval: May 14, 2025 Treatment for: Migraine, Cluster Headaches Press Release | Approval History
- Avmapki Fakzynja Co-Pack (avutometinib and defactinib, co-packaged) Capsules/Tablets
Date of Approval: May 8, 2025 Treatment for: Ovarian Cancer 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. - Otulfi (ustekinumab-aauz) Injection
Approval: April 30, 2025 Now Approved: Interchangeability Designation Press Release | Approval History
- Selarsdi (ustekinumab-aekn) Injection
Approval: April 30, 2025 Now Approved: Interchangeability Designation Press Release | Approval History
- Yuflyma (adalimumab-aaty) Injection
Approval: May 21, 2025 Now Approved: Interchangeability Designation for All Dosage Forms and Strengths Press Release | Approval History
- Zynyz (retifanlimab-dlwr) Injection
Approval: May 15, 2025 Now Approved for: Advanced Anal Cancer Press Release | Approval History
- Zoryve (roflumilast) Cream and Foam
Approval: May 22, 2025 Now Approved for: Plaque Psoriasis in Patients Ages 12 and Older Press Release | Approval History
- Susvimo (ranibizumab) Injection for Intravitreal Use via Ocular Implant
Approval: May 21, 2025 Now Approved for: Diabetic Retinopathy Press Release | Approval History
- Welireg (belzutifan) Tablets
Approval: May 14, 2025 Now Approved for: Pheochromocytoma/Paraganglioma Press Release | Approval History
- Hadlima (adalimumab-bwwd) Injection
Approval: May 21, 2025 Now Approved: Interchangeability Designation for All Dosage Forms and Strengths Press Release | Approval History
- Jivi (antihemophilic factor [recombinant] PEGylated-aucl) Injection
Approval: May 19, 2025 Now Approved for: Pediatric Patients 7 to Under 12 Years of Age Press Release | Approval History
- Nucala (mepolizumab) Injection
Approval: May 22, 2025 Now Approved for: Chronic Obstructive Pulmonary Disease (COPD) 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. - Halobetasol Propionate and Tazarotene Topical Lotion
0.01% / 0.045%
Approved: May 2, 2025 - Taro Pharmaceuticals U.S.A., Inc.
Treatment for: Plaque Psoriasis
Generic for:
Duobrii
- Raltegravir Potassium Tablets
600 mg (base)
Approved: May 6, 2025 - Lupin Pharmaceuticals, Inc.
Treatment for: HIV Infection
Generic for:
Isentress HD
- Rivaroxaban Tablets
10 mg, 15 mg and 20 mg
Approved: May 14, 2025 - Alembic Pharmaceuticals Limited; Ascent Pharmaceuticals, Inc.; Biocon Pharma Inc.; Changzhou Pharmaceutical Factory; Dr. Reddys Laboratories Inc.; InvaGen Pharmaceuticals Inc.; Lupin Pharmaceuticals, Inc.; Macleods Pharmaceuticals Ltd.; Sunshine Lake Pharma Co., Ltd.
Treatment for: Treatment and Prevention of Blood Clots
Generic for:
Xarelto 10 mg, 15 mg and 20 mg
- Emtricitabine, Rilpivirine and Tenofovir Disoproxil Fumarate Tablets
200 mg / 25 mg (base) / 300mg
Approved: May 20, 2025 - Mylan Pharmaceuticals Inc.
Treatment for: HIV Infection
Generic for:
Complera
- Bosutinib Monohydrate Tablets
100 mg (base) and 500 mg (base)
Approved: May 23, 2025 - Alembic Pharmaceuticals Limited
Treatment for: Chronic Myelogenous Leukemia
Generic for:
Bosulif 100 mg (base) and 500 mg (base)
- Perampanel Tablets
2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12mg
Approved: May 23, 2025 - Teva Pharmaceuticals USA, Inc.
Treatment for: Seizures
Generic for:
Fycompa
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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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