Latest posts
-
FDA Approves Vizz Eye Drops for Presbyopia in Adults
What Was Approved? On July 31, 2025, the U.S. Food and Drug Administration approved Vizz (aceclidine ophthalmic solution) for the treatment of presbyopia in adults. Presbyopia is an age-related condition that makes it harder to focus on nearby objects. How Does Vizz Work? Vizz is a cholinergic agonist. Aceclidine causes the pupil to become smaller,…
-
FDA Approves Modeyso for H3 K27M-Mutant Diffuse Midline Glioma
What Was Approved? On August 6, 2025, the U.S. Food and Drug Administration granted accelerated approval to Modeyso (dordaviprone) for adult and pediatric patients 1 year of age and older with diffuse midline glioma harboring an H3 K27M mutation whose disease has progressed after prior therapy. Modeyso is the first FDA-approved systemic therapy specifically for…
-
FDA Approves Brinsupri for Non-Cystic Fibrosis Bronchiectasis
What Was Approved? On August 12, 2025, the U.S. Food and Drug Administration approved Brinsupri (brensocatib) for the treatment of non-cystic fibrosis bronchiectasis in adults and pediatric patients 12 years of age and older. How Does Brinsupri Work? Brinsupri is a dipeptidyl peptidase 1, or DPP1, inhibitor. DPP1 is involved in activating certain neutrophil enzymes…
-
FDA Approves Dawnzera to Prevent Hereditary Angioedema Attacks
What Was Approved? On August 21, 2025, the U.S. Food and Drug Administration approved Dawnzera (donidalorsen) to prevent attacks of hereditary angioedema, or HAE, in adults and pediatric patients 12 years of age and older. Dawnzera is a preventive treatment and is not intended to treat an acute HAE attack once it has started. How…
-
FDA Approves Wayrilz for Persistent or Chronic Immune Thrombocytopenia
What Was Approved? On August 29, 2025, the U.S. Food and Drug Administration approved Wayrilz (rilzabrutinib) for adults with persistent or chronic immune thrombocytopenia, or ITP, who have had an insufficient response to previous treatment. ITP is an autoimmune disorder that can cause abnormally low platelet counts and increase the risk of bleeding. How Does…
-
FDA Approves Palsonify for Adults With Acromegaly
What Was Approved? On September 25, 2025, the U.S. Food and Drug Administration approved Palsonify (paltusotine) for adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option. Palsonify is an oral treatment and should not be described as a general first-line treatment for every patient with acromegaly.…
-
FDA Approves Inluriyo for Certain ESR1-Mutated Advanced Breast Cancers
What Was Approved? On September 25, 2025, the U.S. Food and Drug Administration approved Inluriyo (imlunestrant) for adults with: An FDA-approved test is used to identify eligible patients with an ESR1 mutation. How Does Inluriyo Work? Inluriyo is an estrogen receptor antagonist. It is designed to block estrogen-receptor signaling that can help drive the growth…
-
FDA Approves Rhapsido for Chronic Spontaneous Urticaria
What Was Approved? On September 30, 2025, the U.S. Food and Drug Administration approved Rhapsido (remibrutinib) for adults with chronic spontaneous urticaria, or CSU, who remain symptomatic despite treatment with an H1 antihistamine. Rhapsido is not indicated for other forms of urticaria. What Is Chronic Spontaneous Urticaria? CSU is a condition in which hives, itching,…
-
FDA Approves Jascayd for Idiopathic Pulmonary Fibrosis
What Was Approved? On October 7, 2025, the U.S. Food and Drug Administration approved Jascayd (nerandomilast) for the treatment of idiopathic pulmonary fibrosis, or IPF, in adults. Jascayd was the first new FDA-approved treatment for IPF in more than 10 years. What Is Idiopathic Pulmonary Fibrosis? IPF is a chronic lung disease in which lung…
-
FDA Approves Kygevvi for Thymidine Kinase 2 Deficiency
What Was Approved? On November 3, 2025, the U.S. Food and Drug Administration approved Kygevvi (doxecitine and doxribtimine) for the treatment of thymidine kinase 2 deficiency, or TK2d, in adults and pediatric patients whose symptoms began at 12 years of age or younger. Kygevvi is the first FDA-approved treatment specifically for TK2d. What Is TK2…