Approves

FDA Approves New Drug for Wilson’s Disease

FDA Approves New Drug for Wilson’s Illness

The US Food and Drug Administration (FDA) has approved oral trientine tetrahydrochloride (Cuvrior, Orphalan) for the treatment of adults with stable Wilson’s disease who are decoppered and tolerant to penicillamine, the company has announced. Wilson’s disease is a rare genetic storage disease caused by a defect in a copper transporter gene, leading to copper accumulation…

FDA Approves Leadless, Single-Chamber Pacemaker System

FDA Approves Leadless, Single-Chamber Pacemaker System

The Food and Drug Administration has granted approval to Abbott’s Aveir leadless, single-chamber pacemaker system for patients with bradycardia. In a press release, Abbott said the device has a unique mapping capability that allows interventionists implanting the device to measure electrical signals within the heart to determine the correct placement before final implantation. Aveir is implanted…

FDA Approves Neoadjuvant Nivolumab/Chemo for Early-Stage NSCLC

FDA Approves Neoadjuvant Nivolumab/Chemo for Early-Stage NSCLC

The US Food and Drug Administration (FDA) has approved nivolumab for neoadjuvant treatment of non-small cell lung cancer (NSCLC) in combination with platinum-doublet chemotherapy, regardless of PDL-1 status. Nivolumab is the first immune checkpoint inhibitor to be approved for resectable NSCLC; its three prior NSCLC indications are for metastatic disease, the agency said in its…

FDA Approves Faricimab for nAMD and Diabetic Macular Edema

FDA Approves Faricimab for nAMD and Diabetic Macular Edema

The US Food and Drug Administration (FDA) today approved faricimab (Vabysmo, Genentech/Roche) to treat diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). Compared with antivascular endothelial growth factor (VEGF) drugs currently in use, faricimab requires fewer intravitreal injections on average, so it may reduce the burden on both patients and their physicians while…

Trending Medical and health breaking news FDA Approves Two Oral JAK Inhibitors for Atopic Dermatitis

Trending Medical and well being breaking information FDA Approves Two Oral JAK Inhibitors for Atopic Dermatitis

The Food and Drug Administration on Jan. 14 approved two oral JAK-1 inhibitors for patients with moderate-to-severe atopic dermatitis (AD) — upadacitinib and abrocitinib — making them the first oral JAK inhibitors available for this indication in the United States. “It’s big news because a few years ago we didn’t have any systemic treatments that are safer…

Trending Medical and health breaking news FDA Approves First Injection Regimen for HIV Prevention

Trending Medical and well being breaking information FDA Approves First Injection Routine for HIV Prevention

By Robert Preidt and Robin Foster HealthDay ReportersTUESDAY, Dec. 21, 2021 (HealthDay News) — The first injection drug to prevent HIV infection was approved by the U.S. Food and Drug Administration on Monday.“Today’s approval adds an important tool in the effort to end the HIV epidemic by providing the first option to prevent HIV that…

Trending Medical and health breaking news FDA Approves New Myasthenia Gravis Drug

Trending Medical and well being breaking information FDA Approves New Myasthenia Gravis Drug

The US Food and Drug Administration (FDA) has approved efgartigimod (Vyvgart, argenx), a first-in-class, targeted therapy for adults with generalized myasthenia gravis (gMG) who test positive for the antiacetylcholine receptor (AChR) antibody. “There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases,” Billy Dunn, MD, director, Office…