Steve Duffy, Author at Renal and Urology News

LDL-C Targets for Preexisting Heart Disease

FDA Approves First-in-Class Cholesterol Lowering Therapy

By

Steve Duffy

February 25, 2020

The Food and Drug Administration (FDA) has approved Nexletol (bempedoic acid; Esperion) as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or established atherosclerotic cardiovascular disease (ASCVD) who require additional lowering of low-density lipoprotein cholesterol (LDL-C). Nexletol is a first-in-class adenosine triphosphate-citrate lyase (ACL)…

Urinary Incontinence

Innovo, a Wearable Device for Stress Urinary Incontinence, Now Available OTC

By

Steve Duffy

February 19, 2020

A wearable device to treat stress urinary incontinence, Innovo®, has been granted over-the-counter clearance by the Food and Drug Administration.

Hypogonadism

Jatenzo, an Oral Testosterone Replacement Therapy, Now Available

By

Steve Duffy

February 18, 2020

Jatenzo® (testosterone undecanoate; Clarus Therapeutics), an oral testosterone replacement therapy, is now available for the treatment of hypogonadism.

Uncategorized

Contepo NDA for Complicated UTI Resubmitted

By

Steve Duffy

January 24, 2020

Fosfomycin is a novel, epoxide intravenous antibiotic with a broad spectrum of Gram-negative and Gram-positive activity, including activity against multi-drug resistant (MDR) strains such as extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae.

Practice Management

Haymarket Medical Education Receives Interprofessional Joint Accreditation for the Healthcare Team

January 9, 2020

Caroline O. Pardo, Ph.D., General Manager for Haymarket Medical Education, is pleased to announce that HME, based in Paramus, NJ, has been accredited as a provider of interprofessional continuing education by the Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nursing Credentialing Center.

Uncategorized

Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies

By

Steve Duffy

November 27, 2019

The FDA has approved updated labeling for Epclusa (sofosbuvir/velpatasvir), Harvoni (ledipasvir/sofosbuvir) and Vosevi (sofosbuvir/velpatasvir/voxilaprevir) to include updated information regarding treatment of patients with hepatitis C virus (HCV) who have severe renal impairment including those with end stage renal disease who are on dialysis.

Acute Kidney Injury

FDA Fast-Tracks Therapy for Patients at Risk for Acute Kidney Injury After CABG/Valve Surgery

By

Steve Duffy

October 29, 2019

The FDA has granted Fast Track designation to ASP1128, an investigational treatment for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery.

Chronic Kidney Disease (CKD), Diabetic Nephropathy

Diabetes Tx Gains Fast Track Designation for Kidney Disease

By

Steve Duffy

August 28, 2019

The FDA has granted Fast Track designation to dapagliflozin (Farxiga; AstraZeneca) as a possible treatment to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease.

Urinary Incontinence

OTC Urethral Support Device Now Available to Treat Stress Urinary Incontinence

By

Steve Duffy

June 20, 2019

An over-the-counter device to treat stress urinary incontinence (SUI) in women has been made available by Rinovum Women’s Health.

Chronic Kidney Disease (CKD)

Bardoxolone Gets Orphan Drug Status for Autosomal Dominant Polycystic Kidney Disease

By

Steve Duffy

June 7, 2019

The FDA has granted bardoxolone methyl (bardoxolone; Reata Pharmaceuticals) Orphan Drug designation for the treatment of autosomal dominant polycystic kidney disease (ADPKD).

Steve Duffy

All articles by Steve Duffy

FDA Approves First-in-Class Cholesterol Lowering Therapy

Innovo, a Wearable Device for Stress Urinary Incontinence, Now Available OTC

Jatenzo, an Oral Testosterone Replacement Therapy, Now Available

Contepo NDA for Complicated UTI Resubmitted

Haymarket Medical Education Receives Interprofessional Joint Accreditation for the Healthcare Team

Renal Impairment Labeling Updates for Sofosbuvir-Based HCV Therapies

FDA Fast-Tracks Therapy for Patients at Risk for Acute Kidney Injury After CABG/Valve Surgery

Diabetes Tx Gains Fast Track Designation for Kidney Disease

OTC Urethral Support Device Now Available to Treat Stress Urinary Incontinence

Bardoxolone Gets Orphan Drug Status for Autosomal Dominant Polycystic Kidney Disease

PPI Use Linked to Increased Death From CKD, CVD