Latest posts
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FDA Approves Zycubo, the First Treatment for Menkes Disease
What Was Approved? On January 12, 2026, the U.S. Food and Drug Administration approved Zycubo (copper histidinate) for the treatment of Menkes disease in pediatric patients. Zycubo is the first FDA-approved treatment specifically for Menkes disease. What Is Menkes Disease? Menkes disease is a rare inherited disorder that interferes with the body’s ability to properly…
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FDA Approves Adquey for Mild-to-Moderate Atopic Dermatitis
What Was Approved? On February 12, 2026, the U.S. Food and Drug Administration approved Adquey (difamilast) 1% ointment for the topical treatment of mild-to-moderate atopic dermatitis in adults and pediatric patients 2 years of age and older. How Does Adquey Work? Adquey is a phosphodiesterase 4, or PDE4, inhibitor. PDE4 is involved in inflammatory signaling.…
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FDA Approves Bysanti for Schizophrenia and Bipolar I Mania in Adults
What Was Approved? On February 20, 2026, the U.S. Food and Drug Administration approved Bysanti (milsaperidone) for: Bysanti is an atypical antipsychotic. How Is Bysanti Taken? Bysanti is taken by mouth twice daily, with or without food. The dose is gradually increased to reduce the risk of orthostatic hypotension, or a drop in blood pressure…
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FDA Approves Loargys for Arginase 1 Deficiency
What Was Approved? On February 23, 2026, the U.S. Food and Drug Administration approved Loargys (pegzilarginase-nbln) for the treatment of hyperargininemia in adults and pediatric patients 2 years of age and older with Arginase 1 Deficiency, or ARG1-D. Loargys is used together with dietary protein restriction. What Is Arginase 1 Deficiency? Arginase 1 Deficiency is…
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FDA Approves Yuviwel for Children With Achondroplasia
What Was Approved? On February 27, 2026, the U.S. Food and Drug Administration approved Yuviwel (navepegritide) to increase linear growth in pediatric patients 2 years of age and older with achondroplasia and open epiphyses. The approval was granted through the FDA’s accelerated approval pathway. What Is Achondroplasia? Achondroplasia is a genetic condition that affects bone…
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FDA Approves Lynavoy for Cholestatic Pruritus in Adults With Primary Biliary Cholangitis
What Was Approved? On March 17, 2026, the U.S. Food and Drug Administration approved Lynavoy (linerixibat) for the treatment of cholestatic pruritus associated with primary biliary cholangitis, or PBC, in adults. Lynavoy is intended to treat the itching associated with PBC. It should not be described as a cure for PBC itself. How Does Lynavoy…
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FDA Approves Icotyde for Moderate-to-Severe Plaque Psoriasis
What Was Approved? On March 17, 2026, the U.S. Food and Drug Administration approved Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in: How Does Icotyde Work? Icotyde is an IL-23 receptor antagonist. It selectively binds to the interleukin-23 receptor and blocks IL-23 signaling, which is involved in inflammatory and immune pathways that contribute…
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FDA Approves Avlayah for Neurologic Manifestations of Hunter Syndrome
What Was Approved? On March 24, 2026, the U.S. Food and Drug Administration approved Avlayah (tividenofusp alfa-eknm) for the treatment of neurologic manifestations of Hunter syndrome, also called mucopolysaccharidosis type II or MPS II. The approval applies when treatment is started in presymptomatic or symptomatic pediatric patients weighing at least 5 kg before advanced neurologic…
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FDA Approves Lifyorli With Nab-Paclitaxel for Certain Platinum-Resistant Gynecologic Cancers
What Was Approved? On March 25, 2026, the U.S. Food and Drug Administration approved Lifyorli (relacorilant) in combination with nab-paclitaxel for adults with: Patients must have received one to three prior systemic treatment regimens, including at least one regimen containing bevacizumab. How Does Lifyorli Work? Lifyorli is a glucocorticoid receptor antagonist. It is used with…
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FDA Approves Awiqli, a Once-Weekly Insulin for Adults With Type 2 Diabetes
What Was Approved? On March 26, 2026, the U.S. Food and Drug Administration approved Awiqli (insulin icodec-abae) as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus. Awiqli is a long-acting insulin designed to be administered once weekly. How Is Awiqli Used? Awiqli is injected under…