Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Diabetes Dialogue: Therapeutic Updates from the ADA 2026 Standards of Care

In this episode, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, review key therapy-focused updates from the 2026 ADA Standards of Care, emphasizing areas they view as practice-changing. They begin with updates in heart failure management, highlighting the formal inclusion in the treatment algorithm of GLP-1 receptor agonists and dual GIP/GLP-1 receptor agonists, alongside SGLT2 inhibitors, for patients with symptomatic heart failure with preserved ejection fraction and obesity. Both hosts stress that placement within the algorithm, rather than narrative recommendations alone, is likely to meaningfully shift clinician behavior.

00:00:01 Intro
00:00:29 Adding GLP-1 RAs to heart failure
00:02:45 GLP-1s in glycemic management
00:04:36 Time in range targets in glycemic management
00:08:10 ADA recommends GLP-1s for T1D
00:12:00 GLP-1s in MASH and MASLD
00:12:57 Changes in kidney protection guidelines
00:14:40 New therapeutic guidance for T1D and T2D
00:17:57 Outro

The discussion then turns to advanced chronic kidney disease, where the Standards now recommend GLP-1 receptor agonists as preferred glucose-lowering therapy for adults with type 2 diabetes and eGFR <30 mL/min/1.73 m², including those approaching or receiving dialysis. Isaacs and Bellini underscore the importance of this guidance in moving practice away from reflexive insulin use, citing lower hypoglycemia risk and established cardiovascular benefit as key advantages.

They also highlight updates to glycemic targets, particularly the integration of continuous glucose monitoring–based time-in-range goals alongside A1C targets across varying levels of health status and life expectancy. The hosts emphasize that this addition both normalizes CGM use and encourages more data-driven, patient-centered clinical conversations, especially in older adults and those with complex comorbidities.

A major point of enthusiasm is the first-time recommendation to consider GLP-1 receptor agonists in individuals with type 1 diabetes and obesity. While acknowledging limitations related to BMI thresholds and the absence of cardiovascular outcomes data in type 1 diabetes, the hosts frame this as an important initial step that reflects growing clinical experience and trial evidence for weight, glycemic variability, and insulin-sparing benefits.

The episode also reviews expanded guidance on metabolic dysfunction–associated steatotic liver disease (MASLD/MASH), kidney protection strategies, and cardiovascular risk reduction, including updated monitoring recommendations, blood pressure targets, and the continued emphasis on SGLT2 inhibitors, GLP-1 receptor agonists, and nonsteroidal mineralocorticoid receptor antagonists such as finerenone. The hosts praise the increasingly clear algorithms and visual tools designed to support real-world decision-making across primary and specialty care.

They conclude by encouraging clinicians to engage with the ADA Standards through multiple formats - including the abridged version and mobile app - and to view the guidelines as a living framework to support comprehensive, proactive diabetes care.

Podcasts

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

Type 2 Diabetes

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

2025 marked a turning point for chronic obstructive pulmonary disease (COPD), as years of incremental progress gave way to a more decisive shift toward targeted, biology-driven care. Long defined by symptom management and exacerbation mitigation with inhaled therapies, the field began to meaningfully embrace precision medicine, driven by regulatory milestones, pivotal trial readouts, and a growing recognition of inflammatory heterogeneity within COPD populations.

The FDA approval of mepolizumab for eosinophilic COPD anchored the year’s regulatory narrative, establishing the first IL-5–targeted biologic option for this disease and validating eosinophils as a clinically actionable biomarker. At the same time, trial results underscored both the promise and the challenges of biologics in COPD: tezepelumab failed to meet its primary endpoint, while astegolimab delivered mixed phase 3 results that highlighted the complexity of translating immunologic targets into consistent clinical benefit. Beyond biologics, advances in smoking cessation therapy, most notably with cytisinicline, reinforced the continued importance of foundational interventions alongside novel agents.

Complementing these data were broader shifts in how COPD is conceptualized and managed in practice. Updated GOLD guidelines sharpened guidance on diagnosis, comorbidities, and evidence-based care, while expert discussions increasingly emphasized trait-based approaches that blur traditional boundaries between asthma and COPD, defining 2025 as a year of recalibration for COPD that moved the field closer to personalized care while clarifying where further evidence and refinement are still needed.

FDA Approves Mepolizumab for Eosinophilic COPD

On May 22, the FDA has approved mepolizumab (Nucala) as an add-on maintenance treatment for patients with COPD with an eosinophilic phenotype. In the phase 3 MATINEE trial, mepolizumab demonstrated a statistically significant and clinically meaningful 21% reduction in the annualized rate of moderate or severe exacerbations (0.80 events per year) compared to placebo (1.01 events per year; rate ratio, 0.79; 95% CI, 0.66 to 0.94; 

 = .01), successfully meeting the primary endpoint.

Tezepelumab Fails Study Endpoint of Reducing Moderate-to-Severe COPD Exacerbations

Tezepelumab was not seen to reduce the annualized rate of moderate or severe COPD exacerbations, thus failing the primary endpoint of COURSE, a phase 2a trial (NCT04039113). Singh and colleagues found that the annualized rate of moderate or severe COPD exacerbations represented a nonsignificant change and thus did not meet the trial’s primary endpoint.

Genentech (Roche)’s Astegolimab Shows Mixed Data for COPD

Genentech reported mixed phase 3 results for astegolimab in COPD, with the ALIENTO trial showing a statistically significant 15.4% reduction in annualized exacerbation rate at 52 weeks, while the ARNASA trial failed to meet its primary endpoint despite a similar 14.5% reduction. Neither trial found no new safety signals, but the inconsistent efficacy results may challenge astegolimab’s regulatory path.

Cytisinicline Demonstrates Value as Smoking Cessation Tool in People With or Without COPD

A post-hoc analysis of the phase 3 ORCA-2 and ORCA-3 trials found that cytisinicline significantly increased smoking abstinence rates compared with placebo in both COPD and non-COPD subgroups. In participants with COPD, quit rates reached 17.3%–19.1% with cytisinicline versus 2.1% with placebo, while non-COPD participants achieved 19.3%–32.6% compared to 5.5%–8.6% with placebo. The therapy was well tolerated, with insomnia and headache as the most common adverse events, supporting its potential as a safe and effective smoking cessation option.

Rewriting Airway Disease With Trait-Based Care: 2025’s Convergence of Asthma and COPD Management

Pulmonology is rapidly shifting from rigid disease labels toward a precision, trait-based model, fueled by biomarker insights and the arrival of biologics for COPD. In this This Year in Medicine feature, leading experts discuss how approvals of dupilumab and mepolizumab are blurring the asthma–COPD divide and redefining airway disease management around inflammatory drivers rather than diagnostic silos.

Going for GOLD: Updated COPD Guidelines with Gerard Criner, MD

COPD continues to pose a substantial global and US health burden, prompting updated 2024 GOLD guidelines that sharpen guidance on diagnosis, comorbidity management, and evidence-based care. In this Lungcast episode, Gerard Criner, MD, breaks down key updates, including renewed emphasis on spirometry, smoking cessation, pulmonary rehabilitation, and cardiovascular risk, highlighting how GOLD translates evolving science into practical, patient-centered recommendations.

The Biologic Era in COPD: What Mepolizumab Approval Means for Exacerbation Control

 expert discussion moderated by Joseph Khabbaza, MD, clinicians examine how the FDA approval of mepolizumab for eosinophilic COPD could mark a turning point in a field long limited to symptom-focused therapies. Drawing on phase 3 MATINEE data, the panel highlights its potential to reduce exacerbations, limit systemic steroid exposure, and usher COPD care toward a more asthma-like, biomarker-driven precision model.

Johnson V. FDA Approves Mepolizumab for Eosinophilic COPD. Article. HCPLive. May 22, 2025. https://www.hcplive.com/view/fda-approves-mepolizumab-for-eosinophilic-copd

Johnson V. Tezepelumab Fails Study Endpoint of Reducing Moderate-to-Severe COPD Exacerbations. Article. HCPLive. January 24, 2025. https://www.hcplive.com/view/tezepelumab-fails-study-endpoint-reducing-moderate-to-severe-copd-exacerbations

Johnson V. Genentech (Roche)’s Astegolimab Shows Mixed Data for COPD. Article. HCPLive. July 21, 2025. https://www.hcplive.com/view/genentech-roche-s-astegolimab-shows-mixed-data-for-copd

Johnson V. Cytisinicline Demonstrates Value as Smoking Cessation Tool in People With or Without COPD. Article. HCPLive. September 22, 2025. https://www.hcplive.com/view/cytisinicline-demonstrates-value-smoking-cessation-tool-with-without-copd

Criner G, Rogers L, Ho AT. Rewriting Airway Disease With Trait-Based Care: 2025’s Convergence of Asthma and COPD Management. Article. HCPLive. December 1, 2025. https://www.hcplive.com/view/rewriting-airway-disease-with-trait-based-care-convergence-asthma-copd-management

Rizzo A, Criner G. Going for GOLD: Updated COPD Guidelines with Gerard Criner, MD. Video. HCPLive. May 29, 2025. https://www.hcplive.com/view/going-for-gold-updated-copd-guidelines-with-gerard-criner-md

Khabbaza J, Desai NS, Costanzo E. The Biologic Era in COPD: What Mepolizumab Approval Means for Exacerbation Control. Video. HCPLive. July 30, 2025. https://www.hcplive.com/view/biologic-era-copd-mepolizumab-exacerbation-control

Articles

In 2025, COPD management experienced a significant shift towards precision medicine, emphasizing targeted, biology-driven care. The FDA's approval of mepolizumab for eosinophilic COPD marked a pivotal regulatory milestone, validating eosinophils as a biomarker. However, trial results for other biologics like tezepelumab and astegolimab highlighted challenges in achieving consistent clinical benefits. Advances in smoking cessation therapies, such as cytisinicline, underscored the importance of foundational interventions. Updated GOLD guidelines and expert discussions emphasized a trait-based approach, blurring the lines between asthma and COPD management.

The COPD year in review highlights FDA approvals, data, and advances in 2025.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

COPD in 2025: Year in Review

Benjamin Saylor is the assistant managing editor of 

The May 19, 2025, announcement of former President Joe Biden’s prostate cancer diagnosis placed renewed attention on screening, detection, and treatment of a disease that remains a leading cause of cancer-related death among US men. In the days and weeks that followed, urologists across the country began to notice subtle but meaningful changes in patient behavior and clinical conversations.

 surveyed urologists and advanced practice providers about the real-world impact of the news. Responses suggest an increase in patient questions about PSA testing, heightened anxiety among older men, and growing interest in baseline or continued screening later in life. At the same time, the findings raise important questions about patient understanding of modern diagnostic pathways and the ongoing controversy surrounding prostate cancer screening guidelines.

Together, these insights highlight how a high-profile diagnosis can influence awareness and decision-making in clinical practice. 

 to explore what providers are seeing, what patients are asking, and how this moment may shape future conversations around prostate cancer care.

• Open the survey by clicking the image or link above. It will open the interactive publication in a new browser window.

• Arrows on both sides of the screen allow you to navigate from page to page.

• There are buttons on the bottom-right of your screen to display thumbnails of all the pages beneath the viewer, or to zoom in/out, or make full screen.

• When you come across video content, you can click to watch within the publication.

• For now, the survey link performs better for desktop/laptop viewing. You can view on mobile, but some interactive experiences may not be available. 

• Questions? Problems? Feedback? Please reach out to Assistant Managing Editor Ben Saylor.

• Developed by Urology Times Co–Editor in Chief Michael S. Cookson, MD, MMHC, FACS, the survey polled urologists for their perceptions related to former President Joe Biden's diagnosis of metastatic hormone-sensitive prostate cancer

• In the article accompanying the results, Cookson provides insights on the survey data.

• Also included is an exclusive video with Cookson in which he discusses data from a forthcoming study indicating that prostate cancer–related searches climbed sharply and stayed elevated after former President Biden’s prostate cancer diagnosis.

The announcement of former President Joe Biden's prostate cancer diagnosis has sparked increased interest in prostate cancer screening and detection among patients and healthcare providers. Urologists have observed a rise in patient inquiries about PSA testing and heightened anxiety, particularly among older men. This situation underscores the influence of high-profile diagnoses on public awareness and clinical decision-making. The ongoing debate over prostate cancer screening guidelines is also highlighted, emphasizing the need for improved patient understanding of modern diagnostic pathways and the implications for future prostate cancer care discussions.

Results of an exclusive Urology Times survey indicate heightened concern among older men about prostate cancer screening.

This Year In Medicine

Prostate Cancer Screening After Biden’s Diagnosis: What Urologists Are Seeing in Practice

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

 has evolved significantly in 2025, with the key approvals from the 

 of inclisiran and plozasiran and the major trial advances of olezarsen and enlicitide. 

, hypercholesterolemia, and LDL-C management have all received crucial new preventive or protective measures during the course of the year, providing new resources for historically underserved populations.

Given the amount of critical news from 2025, the editorial team at 

 has collected 13 of the most impactful headlines from the last 12 months, including FDA announcements, critical trial results, and key clinician insights. Catch up on anything you may have missed below.


FDA Approves Inclisiran (Leqvio) Label Update as First-Line Monotherapy in Hypercholesterolemia

On July 31, 2025, inclisiran’s label was updated to allow its use as a first-line monotherapy, along with diet and exercise, to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. Parent company Novartis announced the FDA’s proactive request of the label update, based on the robust LDL-C lowering data for PCSK9-targeting therapies. Prior to the update, inclisiran was required to be used on top of or in combination with statin therapy – the update also revised instances of “primary hyperlipidemia” to “hypercholesterolemia” to enhance focus on LDL-C reduction.


FDA Approves Plozasiran for Adults With Familial Chylomicronemia Syndrome

Plozasiran was approved on November 18, 2025, for the reduction of triglycerides in adult patients with familial chylomicronemia syndrome (FCS). The first-in-class RNA interference therapeutic is designed to reduce the production of apoC-III, a major component of triglyceride-rich lipoproteins and a regulator of triglyceride metabolism. The approval was based on the PALISADE trial, which saw patients receiving plozasiran exhibit an 80% median change in triglycerides from baseline and an 83% decreased risk of acute pancreatitis compared to placebo.


FDA Approves Lerodalcibep-liga (Lerochol) for LDL-C Reduction in Hypercholesterolemia

On December 15, 2025, the FDA approved lerodalcibep-liga, under the brand name Lerochol, as an adjunct to diet and exercise to reduce LDL-C in adults with hypercholesterolemia, including heterozygous familial hypercholesterolemia (HeFH). The novel, small protein-binding, third-generation PCSK9 inhibitor, designed as a once-monthly, single small-volume subcutaneous injections for LDL-C lowering, was approved on the back of the LIBerate program, a series of 5 phase 3 registration studies including 2900 patients.


CORALreef Lipids: Enlicitide Lowers LDL-C as Much as Injectables, With Ann Marie Navar, MD, PhD

The CORALreef Lipids phase 3 trial highlighted the efficacy of an oral, once-daily dose of PCSK9 inhibitor enlicitide in significantly reducing LDL-C compared to placebo in patients with hypercholesterolemia with or at risk of 

atherosclerotic cardiovascular disease (ASCVD)

. The 24-week trial compared enlicitide 20 mg to placebo, displaying an LDL-C reduction of ≤60% in the enlicitide cohort, which was maintained at 52 weeks. Patients also saw a 53% reduction in non-HDL, a 50% reduction in ApoB, and a 28% reduction in Lp(a).


CORE/CORE2: Olezarsen Achieves Primary Endpoint in Severe Hypertriglyceridemia

The phase 3 CORE and CORE2 trials both highlighted olezarsen’s capacity for substantial reductions in fasting triglyceride levels among patients with severe hypertriglyceridemia. The investigative antisense oligonucleotide slows triglyceride clearance by inhibiting lipoprotein lipase activity and the liver’s uptake of triglyceride-rich particles. During the trials, olezarsen demonstrated a placebo-adjusted mean reduction in fasting triglyceride of ≤72% at 6 months, which was sustained for the full 12-month trial period.


VICTORION-Difference: Inclisiran Achieves Primary Endpoint of LDL-C Reduction Versus Placebo

Patients with hypercholesterolemia at high or very high risk of cardiovascular events reached LDL-C goals with inclisiran on top of individually optimized lipid-lowering therapy than with placebo in the VICTORION-Difference trial. The small interfering ribonucleic acid targeting PCSK9 messenger RNA provides a consistent reduction in LDL-C when given twice yearly after initial doses. VICTORION-Difference saw 84.9% of patients in the inclisiran arm achieve guideline-recommended LDL-C goals compared to 31% receiving placebo.


Study Finds Icosapent Ethyl Can Reduce Cardiovascular Risk, Even in Well-Controlled LDL-C

The landmark REDUCE-IT trial further examined icosapent ethyl’s cardiovascular benefits for patients, regardless of their baseline LDL-C levels. The trial was the basis for icosapent ethyl’s 2019 FDA approval for reducing cardiovascular risk as an adjunct to maximally tolerated statin therapy in adults with triglyceride levels ≥150 mg/dL and established cardiovascular disease. This secondary analysis examined a composite endpoint of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, coronary revascularization, or unstable angina based on baseline LDL-C level.


Obicetrapib Achieves Robust LDL-C Reductions in Phase 3 ASCVD Trials

In the BROADWAY and TANDEM phase 3 trials, once-daily oral obicetrapib substantially reduced LDL-C in patients with ASCVD when used as an adjunct to statins. The BROADWAY trial saw obicetrapib achieve a 33% reduction in LDL-C on top of maximally tolerated lipid-lowering therapies, along with a 21% relative reduction in major adverse cardiovascular events. TANDEM saw a fixed-dose combination of obicetrapib and ezetimibe meet all primary endpoints for LDL-C reduction compared with placebo.


RX Review: Updates and Unmet Needs for Familial Chylomicronemia Syndrome

In the first of a 7-part video series discussing recent changes in therapeutic options for patients with FCS, host Viet Le, DMSc, PA-C, a preventive cardiology PA at Intermountain Health and former president of the Academy of Physician Associates in Cardiology, spoke with Christie Ballantyne, MD, chief of cardiovascular research at Baylor College of Medicine and principle investigator in the PALISADE trial, to highlight the challenges and treatment gaps present in FCS care. However, Ballantyne ultimately marks 2025 as a turning point for FCS, with the approval of plozasiran on November 18 and olezarsen’s approval in late 2024 providing targeted therapies capable of substantially reducing triglycerides.


RX Review: Integrating New Therapies in FCS Treatment Algorithms


In the fourth part of this 7-part series, host Viet Le, DMSc, PA-C, and guest Christie Ballantyne, MD, discuss plozasiran and its newfound role in contemporary FCS management. Ballantyne discusses the mechanism of action of small interfering RNA therapies like plozasiran and how they modulate pathways independent of lipoprotein lipase activity. Additionally, the pair discuss how plozasiran expands treatment options in this historically underserved population.


RX Review: Understanding Plozasiran’s Role in FCS Management


In the fifth episode of this 7-part series, host Viet Le, DMSc, PA-C, and guest Christie Ballantyne, MD, discussed the effect olezarsen and plozasiran have had on treatment algorithms for FCS. While the approvals are groundbreaking, Ballantyne cautions careful attention when implementing the new medications, with particular attention to patient needs and existing management principles. He also emphasizes the importance of consistent lipid monitoring and clear communication across the various related specialties, including nutritionists, cardiologists, and lipid specialists.

Lipid management in 2025 has seen significant advancements with FDA approvals of inclisiran, plozasiran, and lerodalcibep-liga, alongside major trial results for olezarsen and enlicitide. These developments offer new preventive measures for ischemic stroke, hypercholesterolemia, and LDL-C management, particularly benefiting underserved populations. Key trials like CORALreef Lipids and VICTORION-Difference have demonstrated the efficacy of novel therapies in reducing LDL-C and triglycerides. Additionally, the REDUCE-IT trial highlighted icosapent ethyl's cardiovascular benefits, while obicetrapib showed robust LDL-C reductions in ASCVD patients.

Catch up on the most impactful headlines in dyslipidemia from all of 2025 with our Year in Review.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Dyslipidemia

FDA News

Dyslipidemia in 2025: Year in Review

Image Credit: US Food and Drug Administration

Announced by parent company MannKind Corporation on December 23, 2025, the 

 has approved a supplemental New Drug Application (sNDA) for the furosemide On-body Infusor (FUROSCIX) to treat edema associated with 

 in pediatric patients weighing ≥43 kg.

“We are pleased to make FUROSCIX available to the pediatric population, a highly specific patient group, offering a convenient option outside the hospital setting for those who meet the weight criteria,” Ajay Ahuja, MD, MBA, chief medical officer of MannKind Corporation, said in a statement.

The FUROSCIX On-body Infusor was initially approved in 2022 for the treatment of edema in adults with chronic HF; later, in 2025, it received approval for adults with CKD as well. This third approval fulfills all post-marketing requirements outlined in the initial approval letter under the Pediatric Research Equity Act.

Furosemide’s initial approval was based on data from the phase 2 AT HOME-HF pilot study, a multicenter, randomized trial investigating subcutaneous furosemide 80 mg/10 mL versus standard of care in 51 patients with chronic HF and worsening congestion, uncontrolled by diuresis. The primary endpoint was a win ratio of a 30-day hierarchy composite of cardiovascular death, HF events, and change in N-terminal pro-B-type natriuretic peptide (NT-proBNP). Secondary endpoints included dyspnea severity, functional capacity, and quality of life.

Ultimately, 51 patients were enrolled and randomly assigned in a 2:1 ratio to either furosemide (n = 34) or standard of care (n = 17). Furosemide displayed greater reductions in body weight; between-group difference in least square mean change was -2.02 kg at day 3 (95% CI, -3.9 to -0.14; 

 = .035). Additionally, the furosemide-to-standard-of-care win ratio was 1.11 (95% CI, 0.48 to 2.5; 

 = .806). The most common adverse event with furosemide at the time was mild infusion site pain (11.8%).

In the same release, MannKind announced the FDA’s acceptance of a separate sNDA for the FUROSCIX ReadyFlow Autoinjector for adult patients with chronic HF or CKD. Unlike the On-body Infusor, the ReadyFlow is designed to deliver a subcutaneous furosemide injection in <10 seconds. If approved, the device could provide patients with a method of managing fluid buildup from home, eliminating the need for hospital admission.

“The FUROSCIX ReadyFlow Autoinjector marks a key milestone in expanding patient options and improving care,” Michael Castagna, PharmD, chief executive officer at MannKind Corporation, said in a separate statement regarding the acceptance. “By delivering treatment in under 10 seconds, the ReadyFlow Autoinjector has the potential to transform how adults with chronic heart failure or chronic kidney disease manage episodes of fluid buildup—providing faster relief, reducing hospital admissions, and lowering overall healthcare costs.”

The FUROSCIX ReadyFlow Autoinjector has been assigned a Prescription Drug User Fee Act (PDUFA) target action date of July 26, 2026.

MannKind Corporation. MannKind Shares FUROSCIX Business Updates. December 23, 2025. Accessed December 23, 2025. 

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-shares-furoscixr-business-updates

Konstam MA, Massaro J, Dhingra R, et al. Avoiding Treatment in Hospital With Subcutaneous Furosemide for Worsening Heart Failure: A Pilot Study (AT HOME-HF). JACC Heart Fail. 2024;12(11):1830-1841. 

MannKind Corporation. MannKind Announces U.S. FDA Accepts for Review its Supplemental New Drug Application (sNDA) of FUROSCIX ReadyFlow Autoinjector for the Treatment of Edema in Adults with Chronic Heart Failure or Chronic Kidney Disease. December 1, 2025. Accessed December 23, 2025. 

https://investors.mannkindcorp.com/news-releases/news-release-details/mannkind-announces-us-fda-accepts-review-its-supplemental-new

The FDA has approved a supplemental New Drug Application for the FUROSCIX On-body Infusor to treat edema in pediatric patients with chronic heart failure and chronic kidney disease. Initially approved for adults, this marks the third approval for FUROSCIX, fulfilling Pediatric Research Equity Act requirements. The approval was based on the AT HOME-HF pilot study, which showed significant weight reduction in patients. Additionally, the FDA is reviewing the FUROSCIX ReadyFlow Autoinjector, designed for rapid subcutaneous furosemide delivery, with a decision expected by July 2026.

The FDA has approved an sNDA for the FUROSCIX On-body Infusor in pediatric patients and accepted another for the FUROSCIX ReadyFlow Autoinjector.

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

Chronic Kidney Disease

FDA Approves FUROSCIX On-Body Injector for Pediatric Patients, Accepts sNDA for ReadyFlow Autoinjector

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

A review found increased anxiety, depression, social anxiety, and perceived stress among individuals with androgenetic alopecia compared with those without the condition.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Alopecia

Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Psychological Distress Greater in Patients With Androgenetic Alopecia

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

A multinational survey suggests even slowly progressing C3G and IC-MPGN substantially affect patients, caregivers, and healthcare systems.


C3 Glomerulopathy

The HCPLive C3 glomerulopathy page is a resource for medical news and expert insights on C3G. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in C3G, and more.

C3G, IC-MPGN Report A Disruptive Burden Regardless of Slowed Disease Progression 

Videos

Explore the barriers to PCSK9 inhibitors, their underuse, and how addressing misconceptions can enhance patient outcomes in cholesterol management.

Video Series

Barriers to Using PCSK9-Targeting Therapies

Experts discuss evolving strategies in atherosclerosis prevention, emphasizing early intervention and the importance of cholesterol monitoring for better patient outcomes.

Rethinking Prevention in ASCVD Through Cumulative LDL Exposure

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

The MASH/MASLD year in review highlights FDA approvals, resmetirom data, semaglutide, pemvidutide, and advances in fibrosis and noninvasive endpoints in 2025.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

MASH/MASLD in 2025: Year in Review

Findings from a retrospective observational cohort study indicate podometrics may inform a less invasive treatment approach in IgA nephropathy (IgAN).


IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

Podometrics Could Guide IgAN Treatment While Reducing Invasiveness

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

To stay informed, catch up on some of the most notable alopecia areata news headlines from 2025 with our Year in Review.

Alopecia in 2025: Year in Review

Sayna Norouzi, MD, is an assistant professor of medicine, clinical nephrologist, and founder and director of the glomerular disease and polycystic kidney disease clinics at Loma Linda University Medical Center.

In this segment, the panel discusses how monitoring strategies will need to adapt as B-cell–targeted therapies such as atacicept, sibeprenlimab, and povetacicept move into broader clinical use.

Monitoring Considerations with Emerging B-Cell Modulators in IgAN

In this segment, the panel reviews the emerging clinical data for two additional BAFF/APRIL–pathway inhibitors: sibeprenlimab and povetacicept. 

Additional Emerging BAFF and APRIL Inhibitors in IgAN

A study found that higher PM2.5 exposure during the first year after NICU discharge increased asthma risk in children with bronchopulmonary dysplasia by age 5.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

Latest News

Diabetes Dialogue: Therapeutic Updates from the ADA 2026 Standards of Care

COPD in 2025: Year in Review

Prostate Cancer Screening After Biden’s Diagnosis: What Urologists Are Seeing in Practice

Dyslipidemia in 2025: Year in Review

FDA Approves FUROSCIX On-Body Injector for Pediatric Patients, Accepts sNDA for ReadyFlow Autoinjector