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May 13, 2022

FDA Approves Oral Form of ALS Drug Edaravone FDA Approves Oral Form of ALS Drug Edaravone

The US Food and Drug Administration (FDA) has approved an orally administered version of edaravone (Radicava ORS) for adults with amyotrophic lateral sclerosis (ALS).  Edaravone is […]
May 6, 2022

Potential Risk From Fresenius Dialysis Units, FDA Warns Potential Risk From Fresenius Dialysis Units, FDA Warns

The US Food and Drug Administration (FDA) today warned clinicians of a potential risk for patient exposure to toxic compounds associated with the use of certain […]
May 5, 2022

FDA OKs Trastuzumab Deruxtecan for Earlier Use in Breast Cancer FDA OKs Trastuzumab Deruxtecan for Earlier Use in Breast Cancer

The US Food and Drug Administration (FDA) has granted standard approval to fam-trastuzumab deruxtecan-nxki (Enhertu) for patients with unresectable or metastatic HER2-positive breast cancer who have […]
May 4, 2022

FDA Clears Diagnostic Test for Early Alzheimer’s FDA Clears Diagnostic Test for Early Alzheimer’s

The US Food and Drug Administration (FDA) has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer’s disease (AD) The Lumipulse […]
May 4, 2022

FDA Approves Two Vonoprazan Therapies for H pylori Eradication FDA Approves Two Vonoprazan Therapies for H pylori Eradication

The US Food and Drug Administration (FDA) has approved two vonoprazan-based treatments for Helicobacter pylori infection: Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak […]
May 3, 2022

FDA Approves New Drug for Wilson’s Disease FDA Approves New Drug for Wilson’s Disease

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 […]
April 29, 2022

FDA Warns of Pump Defect With Medtronic HVAD System FDA Warns of Pump Defect With Medtronic HVAD System

Patients implanted with the Medtronic Heartware Ventricular Assist Device (HVAD) System who develop pump thrombosis could have a welding defect in the internal pump causing the […]
April 29, 2022

FDA Okays First-in-Class Treatment for Obstructive HCM FDA Okays First-in-Class Treatment for Obstructive HCM

The US Food and Drug Administration (FDA) has approved mavacamten (Camzyos, Bristol Myers Squibb) to improve functional capacity and symptoms in adults with symptomatic New York […]
April 26, 2022

Class I Recall of Medtronic Pulmonary Valve System Catheter Class I Recall of Medtronic Pulmonary Valve System Catheter

Medtronic has recalled the Harmony delivery catheter, part of the Harmony Transcatheter Pulmonary Valve (TPV) System, because the bond holding the capsule at the end of […]
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