Latest posts
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FDA Approves Avmapki Fakzynja Co-Pack for KRAS-Mutated Low-Grade Serous Ovarian Cancer
What Was Approved? On May 8, 2025, the U.S. Food and Drug Administration granted accelerated approval to Avmapki Fakzynja Co-Pack (avutometinib and defactinib) for adults with KRAS-mutated recurrent low-grade serous ovarian cancer, or LGSOC, who have received prior systemic therapy. The treatment is specifically for tumors with a KRAS mutation. What Is Avmapki Fakzynja Co-Pack?…
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FDA Approves Emrelis for Certain c-Met-Overexpressing Lung Cancers
What Was Approved? On May 14, 2025, the U.S. Food and Drug Administration granted accelerated approval to Emrelis (telisotuzumab vedotin-tllv) for adults with locally advanced or metastatic non-squamous non-small cell lung cancer, or NSCLC, with high c-Met protein overexpression who have received prior systemic therapy. High c-Met expression is defined in the FDA label as…
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FDA Approves Tryptyr Eye Drops for Dry Eye Disease
What Was Approved? On May 28, 2025, the U.S. Food and Drug Administration approved Tryptyr (acoltremon ophthalmic solution) 0.003% for the treatment of the signs and symptoms of dry eye disease in adults. How Does Tryptyr Work? Tryptyr is a TRPM8 thermoreceptor agonist. It stimulates sensory pathways involved in tear production and is intended to…
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FDA Approves Enflonsia to Prevent RSV Lower Respiratory Tract Disease in Infants
What Was Approved? On June 9, 2025, the U.S. Food and Drug Administration approved Enflonsia (clesrovimab-cfor) to prevent respiratory syncytial virus, or RSV, lower respiratory tract disease in neonates and infants who are born during or entering their first RSV season. Enflonsia is a preventive antibody treatment, not a treatment for an active RSV infection.…
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FDA Approves Ibtrozi for ROS1-Positive Non-Small Cell Lung Cancer
What Was Approved? On June 11, 2025, the U.S. Food and Drug Administration approved Ibtrozi (taletrectinib) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, or NSCLC. Patients should be selected for treatment based on the presence of a qualifying ROS1 rearrangement in the tumor. How Does Ibtrozi Work? Ibtrozi is a…
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FDA Approves Lynozyfic for Heavily Pretreated Multiple Myeloma
What Was Approved? On July 2, 2025, the FDA granted accelerated approval to Lynozyfic (linvoseltamab-gcpt) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including: How Does Lynozyfic Work? Lynozyfic is a BCMA-directed CD3 bispecific T-cell engager. It is designed to bring T cells into contact…
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FDA Approves Zegfrovy for Certain EGFR Exon 20 Insertion-Mutated Lung Cancers
What Was Approved? On July 2, 2025, the FDA approved Zegfrovy (sunvozertinib) for adults with locally advanced or metastatic non-small cell lung cancer, or NSCLC, whose tumors have an EGFR exon 20 insertion mutation and whose disease has progressed on or after platinum-based chemotherapy. An FDA-approved test is required to identify the qualifying mutation. How…
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FDA Approves Ekterly for Acute Hereditary Angioedema Attacks
What Was Approved? On July 3, 2025, the U.S. Food and Drug Administration approved Ekterly (sebetralstat) for the treatment of acute hereditary angioedema, or HAE, attacks in adults and pediatric patients 12 years of age and older. Ekterly treats an attack after it begins. It is not a preventive maintenance treatment. How Does Ekterly Work?…
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FDA Approves Anzupgo for Moderate-to-Severe Chronic Hand Eczema
What Was Approved? On July 23, 2025, the U.S. Food and Drug Administration approved Anzupgo (delgocitinib) cream for adults with moderate-to-severe chronic hand eczema who have had an inadequate response to topical corticosteroids or for whom topical corticosteroids are not advisable. How Does Anzupgo Work? Anzupgo is a topical Janus kinase, or JAK, inhibitor. It…
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FDA Approves Sephience for Sepiapterin-Responsive Phenylketonuria
What Was Approved? On July 28, 2025, the U.S. Food and Drug Administration approved Sephience (sepiapterin) for the treatment of hyperphenylalaninemia in adults and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria, or PKU. Sephience must be used together with a phenylalanine-restricted diet. What Is PKU? Phenylketonuria is an inherited metabolic disorder…