Latest posts
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FDA Approves Komzifti for Certain Adults With Relapsed or Refractory AML
What Was Approved? On November 13, 2025, the U.S. Food and Drug Administration approved Komzifti (ziftomenib) for adults with relapsed or refractory acute myeloid leukemia, or AML, with a susceptible NPM1 mutation who have no satisfactory alternative treatment options. Komzifti is not approved for every patient with AML. How Does Komzifti Work? Komzifti is a…
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FDA Approves Redemplo for Adults With Familial Chylomicronemia Syndrome
What Was Approved? On November 18, 2025, the U.S. Food and Drug Administration approved Redemplo (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome, or FCS. FCS is a rare inherited disorder that can cause extremely high triglyceride levels. How Does Redemplo Work? Redemplo is an APOC-III-directed small interfering…
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FDA Approves Hyrnuo for Certain HER2-Mutated Non-Small Cell Lung Cancers
What Was Approved? On November 19, 2025, the U.S. Food and Drug Administration granted accelerated approval to Hyrnuo (sevabertinib) for adults with locally advanced or metastatic non-squamous non-small cell lung cancer, or NSCLC, whose tumors have specific HER2 (ERBB2) tyrosine kinase domain activating mutations. Patients must also have received a prior systemic therapy. An FDA-approved…
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FDA Approves Voyxact to Reduce Proteinuria in Adults With IgA Nephropathy
What Was Approved? On November 25, 2025, the U.S. Food and Drug Administration approved Voyxact (sibeprenlimab-szsi) to reduce proteinuria in adults with primary immunoglobulin A nephropathy, or IgAN, who are at risk for disease progression. The approval was granted through the FDA’s accelerated approval pathway. How Does Voyxact Work? Voyxact is an APRIL blocker. APRIL…
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FDA Approves Lerochol for Adults With High LDL Cholesterol
What Was Approved? On December 12, 2025, the U.S. Food and Drug Administration approved Lerochol (lerodalcibep-liga) as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol, or LDL-C, in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). How Does Lerochol Work? Lerochol is a PCSK9 inhibitor. PCSK9 promotes breakdown of LDL receptors in…
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FDA Approves Nuzolvence for Uncomplicated Urogenital Gonorrhea
What Was Approved? On December 12, 2025, the U.S. Food and Drug Administration approved Nuzolvence (zoliflodacin) for the treatment of uncomplicated urogenital gonorrhea caused by Neisseria gonorrhoeae in: Nuzolvence is not approved as a general treatment for every type or location of gonorrhea infection. How Does Nuzolvence Work? Nuzolvence is a spiropyrimidinetrione bacterial type II…
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FDA Approves Cardamyst Nasal Spray for Acute PSVT Episodes
What Was Approved? On December 12, 2025, the U.S. Food and Drug Administration approved Cardamyst (etripamil) nasal spray for the conversion of acute symptomatic paroxysmal supraventricular tachycardia, or PSVT, to sinus rhythm in adults. PSVT is a type of rapid heart rhythm that can start and stop suddenly. How Is Cardamyst Used? Cardamyst is designed…
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FDA Approves Exdensur for Severe Eosinophilic Asthma
What Was Approved? On December 16, 2025, the U.S. Food and Drug Administration approved Exdensur (depemokimab-ulaa) as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adults and pediatric patients 12 years of age and older. Exdensur is not intended to replace a rescue inhaler for sudden asthma symptoms. How Is Exdensur…
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FDA Approves Yartemlea for Stem Cell Transplant-Associated Thrombotic Microangiopathy
What Was Approved? On December 23, 2025, the U.S. Food and Drug Administration approved Yartemlea (narsoplimab-wuug) for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA, in adults and pediatric patients 2 years of age and older. Yartemlea is the first FDA-approved treatment specifically for TA-TMA. What Is TA-TMA? TA-TMA is a serious…
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FDA Approves Nereus to Prevent Vomiting Caused by Motion
What Was Approved? On December 30, 2025, the U.S. Food and Drug Administration approved Nereus (tradipitant) for the prevention of vomiting induced by motion in adults. Nereus is intended to be taken before an event expected to cause motion-related vomiting. How Does Nereus Work? Nereus is a substance P/neurokinin-1, or NK-1, receptor antagonist. Blocking NK-1…