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Drug |
Pharmacologic Class |
Indication |
More Information |
| Cardiovascular Disease | |||
| Enbumyst (bumetanide nasal spray) | Loop diuretic | Treatment of edema associated with congestive heart failure, and hepatic and renal disease, including nephrotic syndrome in adults. | FDA Approves Enbumyst, an Intranasal Formulation of Bumetanide |
| Evkeeza (evinacumab-dgnb) | Recombinant human monoclonal antibody that binds to and inhibits angiopoietin-like 3 | To include children aged 1 year and older with homozygous familial hypercholesterolemia. | Evkeeza Approval Expanded to Include Younger HoFH Patients |
| Dermatological Disorders | |||
| Opzelura (ruxolitinib cream 1.5%) | Janus kinase inhibitor | Treatment of mild to moderate atopic dermatitis in nonimmunocompromised adult and pediatric patients, 2 years of age and older, whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. | Opzelura Now Indicated for Younger Patients With Atopic Dermatitis |
| Tremfya (guselkumab) | Interleukin-23 antagonist | Treatment of pediatric patients 6 years and older weighing at least 40kg with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and for the treatment of active psoriatic arthritis. | Tremfya Approved for Children With Plaque Psoriasis, Psoriatic Arthritis |
| Vyjuvek (beremagene geperpavec-svdt) | Herpes-simplex virus type 1 vector-based gene therapy that delivers 2 copies of the collagen type VII alpha 1 (COL7A1) gene. | Treatment of wounds in adult and pediatric patients with dystrophic epidermolysis bullosa with mutation(s) in the COL7A1 gene. | Updated Vyjuvek Label Allows for Use in Younger DEB Patients and At-Home Administration |
| Endocrine Disorders | |||
| Palsonify (paltusotine) | Somatostatin receptor type 2 nonpeptide agonist | Treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. | Palsonify, an Oral Therapy for Acromegaly, Gets FDA Approval |
| Hematological Disorders | |||
| Vonvendi (von Willebrand factor [recombinant]) | Coagulation factor | To reduce the frequency of bleeding episodes in adults with von Willebrand Disease (VWD), including those with Type 1 and Type 2 disease, and on-demand and perioperative management of bleeding in pediatric patients with VWD. | Vonvendi Gains Expanded Approval in Von Willebrand Disease |
| Immune Disorders | |||
| Qivigy (immune globulin intravenous [IV], human-kthm) | Immune globulin | Treatment of adults with primary humoral immunodeficiency. | Qivigy Approved for Primary Humoral Immunodeficiency in Adults |
| Metabolic Disorders | |||
| Forzinity (elamipretide HCl) | Mithocondrial cardiolipin binder | To improve muscle strength in adult and pediatric patients with Barth syndrome weighing at least 30kg. | Forzinity Gets Accelerated Approval for Barth Syndrome |
| Koselugo (selumetinib) | Kinase inhibitor | Treatment of pediatric patients aged 1 year and older with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. | Koselugo Approved for NF1 Plexiform Neurofibromas in Younger Patients |
| Neurologic Disorders | |||
| Leqembi Iqlik (lecanemab-irmb subcutaneous formulation) | Amyloid beta-directed antibody | Treatment of Alzheimer disease in patients with mild cognitive impairment or mild dementia stage of disease. | Lecanemab SC Formulation Approved for Maintenance Dosing in Early Alzheimer Disease |
| Oncology | |||
| Inluriyo (imlunestrant) |
Estrogen receptor antagonist
|
Treatment of adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer whose disease progressed after at least 1 line of endocrine therapy. | Inluriyo Approved for ER+, HER2-, ESR1-Mutated Metastatic Breast Cancer |
This article originally appeared on MPR
