Latest posts
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FDA Approves Genglycos, the First Treatment for Glycogen Storage Disease Type Ia
What Was Approved? On August 19, 2026, the U.S. Food and Drug Administration granted accelerated approval to Genglycos (pariglasgene brecaparvovec-opnr) for adults and children 8 years of age and older with glycogen storage disease type Ia, or GSDIa. The treatment is approved to help reduce daily cornstarch intake when used as an adjunct to nutritional…
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FDA Approves Imaavy as the First Treatment for Warm Autoimmune Hemolytic Anemia
What Was Approved? On August 25, 2026, the U.S. Food and Drug Administration approved Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia, or wAIHA, in adults and pediatric patients 12 years of age and older who are currently or previously treated with corticosteroids. Imaavy is the first FDA-approved treatment specifically for wAIHA. What…
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FDA Approves Tauklarify for Tau PET Imaging in Adults Being Evaluated for Alzheimer’s Disease
What Was Approved? On August 13, 2026, the U.S. Food and Drug Administration approved Tauklarify (florquinitau F 18) for positron emission tomography, or PET, imaging of the brain in certain adults with cognitive impairment who are being evaluated for Alzheimer’s disease. The purpose of the scan is to help identify tau neurofibrillary tangle pathology, one…
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FDA Approves Rasonque for Metastatic Pancreatic Cancer
What Was Approved? On August 26, 2026, the U.S. Food and Drug Administration approved Rasonque (daraxonrasib) for the treatment of metastatic pancreatic cancer. Rasonque is a targeted therapy designed to inhibit certain forms of the RAS protein, which can play an important role in driving pancreatic cancer growth. What Type of Pancreatic Cancer Is Involved?…
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FDA Approves Lisraya, the First Oral Treatment for Dermatomyositis in Adults
What Was Approved? On August 27, 2026, the U.S. Food and Drug Administration approved Lisraya (brepocitinib) for the treatment of dermatomyositis in adults. Lisraya is the first FDA-approved oral treatment specifically indicated for adult dermatomyositis. What Is Dermatomyositis? Dermatomyositis is a rare autoimmune disease that can affect both muscles and skin. It may cause symptoms…
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FDA Approves Zenbexus for Previously Treated Multiple Myeloma
What Was Approved? On August 13, 2026, the FDA granted accelerated approval to Zenbexus (iberdomide) in combination with daratumumab and hyaluronidase-fihj plus dexamethasone for certain adults with multiple myeloma. Who Is This Treatment For? The approval is for adults with multiple myeloma who have received at least one previous line of therapy that included: This…
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FDA Approves Orzeyful for Narcolepsy Type 1
What Was Approved? On August 5, 2026, the FDA approved Orzeyful (oveporexton) for adults with narcolepsy type 1. Narcolepsy type 1 is a chronic neurological disorder that can cause excessive daytime sleepiness, cataplexy, and other sleep-related symptoms. How Is Orzeyful Different? Orzeyful is the first approved medicine that directly targets the loss of orexin signaling,…
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FDA Approves Lynkuet for Moderate to Severe Menopausal Hot Flashes
What Was Approved? The FDA approved Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms due to menopause. Vasomotor symptoms include hot flashes and night sweats, which can significantly affect sleep and quality of life. How Does Lynkuet Work? Lynkuet is a non-hormonal treatment. It works by targeting neurokinin pathways involved in the…
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FDA Approves Pasatru for Fibrodysplasia Ossificans Progressiva
What Was Approved? On August 19, 2026, the FDA approved Pasatru (garetosmab-grts) for adults with fibrodysplasia ossificans progressiva (FOP). FOP is a rare genetic disorder in which soft tissues such as muscles, tendons, and ligaments can gradually turn into bone. What Does Pasatru Do? Pasatru is approved to help: Heterotopic ossification means abnormal bone formation…
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FDA Approves New First-Line Treatment for HER2-Positive Advanced Gastric Cancer
What Was Approved? On August 25, 2026, the FDA approved zanidatamab-hrii (Ziihera) in combination with chemotherapy as a first-line treatment for certain adults with HER2-positive advanced gastric, gastroesophageal junction, or esophageal adenocarcinoma. For some patients, Ziihera is also approved in combination with tislelizumab-jsgr (Tevimbra) and chemotherapy. Who Is This Treatment For? The approval applies to…