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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.

Robert Attaran, MD, MBBS | Image Credit: Yale School of Medicine

On June 30, 2025, the Society for Cardiovascular Angiography and Interventions (SCAI) published its first clinical practice guidelines on the treatment of 

Composed of 9 formal recommendations for 8 clinical scenarios addressed by the guideline panel, “SCAI Clinical Practice Guidelines for the Management of Chronic Venous Disease” provides recommendations on a variety of therapeutic options, including compression therapy, wound care, ablation, sclerotherapy, phlebectomy, and deep vein stenting. The guidelines also provide practical insights on which patients may benefit from conservative therapy and when to escalate to invasive options.

“These are the first SCAI guidelines focused on chronic venous disease, and they come at a time of increasing recognition of the burden it places on patients and healthcare systems,” said Robert Attaran, MD, MBBS, chair of the guideline writing community and member of the SCAI Vascular Disease Council. “CVD may present with discomfort, heaviness, and swelling, but it can progress to venous ulcers that are difficult to heal and severely impair quality of life. Our recommendations aim to provide clinicians and patients with a roadmap for personalized, evidence-informed care.”

The guidelines are based on a technical review conducted by the SCAI, which aimed to answer 8 separate research questions regarding the safety and efficacy of several treatment modalities in patients with symptomatic varicose veins and/or venous ulceration. Each of these questions was based on specific clinical scenarios. Special consideration was given to varied levels of evidence relevant to venous autonomy.

The SCAI’s technical review consisted of 2 major sections. The first involved looking for high-quality published systematic reviews relevant to the questions, and the second was 3 de novo systematic reviews on ablation therapy, sclerotherapy, and phlebectomy. An initial total of 3648 titles and abstracts were collected; after filtering for eligibility criteria, 19 were selected to inform the technical review.

Individual recommendations were categorized as “strong” or “conditional” based on the evidence’s certainty, among other contextual considerations. The guidelines also introduce 2 algorithms of treatment: the first for patients with symptomatic varicose veins, and the second for patients with venous ulcer disease.

Despite the in-depth analysis, the SCAI notes in the guidelines themselves the uncertainty of evidence for the effect on healing rate, symptom score, quality of life, and disease recurrence of perforator vein ablation, venoplasty, and stenting for iliocaval obstruction, sclerotherapy, and phlebectomy of symptomatic varicose veins.

Additionally, the panel reported an inability to meaningfully pool data for questions 5, 7, and 8, as the underlying studies were deemed too dissimilar from each other. Similarly, very low certainty evidence suggests sclerotherapy of varicose veins for the reduction of symptom scores, as well as demonstrating a benefit of IPV ablation compared to conservative management for the treatment of venous ulcer disease.

Considering these limitations, the SCAI panel also endorses further research, acknowledging knowledge gaps in the review and suggesting examination of specific ablation modalities for C2-C4 disease, treatment of perforator and accessory reflux, and other specific clinical situations.

“These guidelines reflect SCAI’s commitment to bringing high-quality, evidence-based standards to areas where our members are increasingly practicing,” said SCAI president Srihari Naidu, MD. “As interventional cardiologists take a larger role in managing chronic venous disease, a common problem affecting millions of people, these recommendations will help ensure that patient care remains both consistent and personalized.”

Society for Cardiovascular Angiography and Interventions. SCAI clinical document provides clinical practice guidelines for the management of chronic venous disease. Eurekalert! July 1, 2025. Accessed July 2, 2025. 

https://www.eurekalert.org/news-releases/1089598

Attaran R, Edwards M, Bunte M, et al. SCAI Technical Review on Management of Chronic Venous Disease. 

Articles

The Society for Cardiovascular Angiography and Interventions (SCAI) released its inaugural clinical practice guidelines for managing chronic venous disease (CVD), offering nine recommendations across eight clinical scenarios. These guidelines cover therapeutic options such as compression therapy, ablation, and sclerotherapy, and provide insights on patient-specific treatment escalation. The guidelines are based on a comprehensive technical review, which included systematic reviews and categorized recommendations as "strong" or "conditional." Despite some evidence uncertainties, the guidelines emphasize personalized, evidence-informed care and highlight the need for further research in specific areas.

Based on 8 major questions and consisting of 9 formal recommendations, the SCAI’s guidelines aim to advise clinicians on what treatments to use when.

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SCAI Releases First Ever Guidelines for Managing Chronic Venous Disease

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

The second quarter of 2025 delivered a wave of impactful FDA approvals across a spectrum of rare and chronic diseases, expanding treatment options and advancing precision medicine. Highlights included the first-ever therapies approved for immunoglobulin G4-related disease with inebilizumab and alkaptonuria with nitisinone, marking long-awaited milestones for underserved patient communities. New approvals for atrasentan in IgA nephropathy and beremagene geperpavec gene therapy for recessive dystrophic epidermolysis bullosa also broke new ground in nephrology and dermatology, respectively, providing innovative options where few existed before.

Meanwhile, regulatory progress in respiratory and infectious diseases brought approvals like once-daily roflumilast foam for scalp and body psoriasis, mepolizumab for eosinophilic COPD, and clesrovimab for RSV prevention in infants, reflecting a trend toward targeted therapies that simplify treatment and improve adherence. Additionally, the approval of twice-yearly lenacapavir for HIV prevention offered a transformative new approach to PrEP, while new treatments for giant cell arteritis and generalized myasthenia gravis underscored the quarter’s broad reach in expanding care.

Check out this Q2 2025 FDA news month in review for a recap of HCPLive’s coverage of the top FDA approvals and research from the past few months:

Indication: Reducing proteinuria in patients with IgA nephropathy (IgAN)

Background: Approval based on interim results from the phase 3 ALIGN trial, where atrasentan demonstrated significant reductions in proteinuria. These findings support its use as a disease-modifying therapy in IgAN, addressing a critical unmet need in this patient population.

Understanding Atrasentan (Vanrafia) for IgA Nephropathy, with Richard Lafayette, MD

Indication: Treatment of adults with immunoglobulin G4-related disease (IgG4-RD)

Background: Approval supported by data from the phase 3 NATRON trial, in which inebilizumab significantly reduced the risk of disease flare compared to placebo. This marks the first FDA-approved therapy specifically for IgG4-RD, a chronic fibroinflammatory condition previously managed with less targeted treatments.

Indication: Treatment of recessive dystrophic epidermolysis bullosa (RDEB)

Background: Approval based on data from the GEM-3 trial, showing Vyjuvek, a topical gene therapy, significantly improved wound healing and skin integrity in patients with RDEB. Vyjuvek is the first gene therapy approved for this devastating genetic skin disorder.

Indication: Treatment of giant cell arteritis (GCA) in adults

Background: Approval based on results from the SELECT-GCA trial, where upadacitinib achieved sustained remission and reduced glucocorticoid use. This provides a novel oral treatment option for patients with GCA, expanding therapeutic choices for this inflammatory vascular disease.

Indication: Treatment of generalized myasthenia gravis (gMG) in adults and children aged ≥12 years

Background: Approval based on data from the Vivacity-MG study, which demonstrated that nipocalimab significantly improved muscle strength and reduced disease severity in patients with gMG, offering a new targeted therapy for this neuromuscular disorder.

Indication: Treatment of eosinophilic chronic obstructive pulmonary disease (COPD)

Background: Approval based on phase 3 trials demonstrating mepolizumab significantly reduced exacerbation rates in patients with elevated eosinophil counts. Mepolizumab becomes the first biologic approved for this COPD phenotype, marking an advance in personalized respiratory care.

Indication: Treatment of plaque psoriasis involving the scalp and body in patients aged ≥12 years

Background: Approval supported by positive results from the phase 3 ARRECTOR trial, where once-daily roflumilast foam provided significant improvements in psoriasis affecting hard-to-treat areas like the scalp. This non-steroidal topical option expands treatment choices for patients.

Understanding Roflumilast Foam's FDA Approval for Scalp and Body Psoriasis, with Jennifer Soung, MD

Indication: Prevention of RSV lower respiratory tract disease in neonates and infants entering their first RSV season

Background: Approval based on pivotal phase 2b/3 CLEVER trial data, which showed clesrovimab reduced RSV-associated medically attended lower respiratory infections by 60.5% and hospitalizations by 84.3% through 5 months. Enflonsia is the first RSV preventive given at a fixed 105 mg dose regardless of weight, offering durable protection for infants.

RX Review: RSV Prevention Strategies and the Changing Epidemiologic Landscape

Indication: Prophylactic prevention of hereditary angioedema (HAE) attacks in patients aged ≥12 years

Background: Approval based on the phase 3 VANGUARD trial, where garadacimab-gxii achieved ≥99% median reduction in HAE attacks compared to placebo, with 62% of treated patients remaining attack-free. ANDEMBRY is the first HAE therapy targeting factor XIIa, offering once-monthly subcutaneous administration.

https://www.hcplive.com/view/fda-approves-first-twice-yearly-hiv-prevention-option

FDA Approves Lenacapavir, First Twice-Yearly HIV Prevention Option

On June 18, 2025, Gilead announced FDA approval of lenacapavir (Yeztugo) as a twice-yearly injectable pre-exposure prophylaxis (PrEP) for preventing sexually acquired HIV in adults and adolescents weighing at least 35 kg. Based on phase 3 PURPOSE 1 and PURPOSE 2 trials, lenacapavir demonstrated superior efficacy with zero HIV infections in cisgender women during the study and significantly fewer infections in men and gender-diverse individuals compared to daily oral PrEP. This novel dosing regimen offers a transformative option to improve adherence and reduce stigma associated with more frequent PrEP dosing.

FDA Approves Nitisinone (HARLIKU) for Treatment of Alkaptonuria

On June 19, 2025, Cycle Pharmaceuticals announced FDA approval of nitisinone (HARLIKU) for reducing urine homogentisic acid in adults with alkaptonuria (AKU), making it the first and only treatment approved for this rare genetic disorder. Based on a post-hoc analysis of a 2009 trial, nitisinone demonstrated improvements in patient-reported outcomes and physical function over three years, supporting its efficacy despite the original trial missing its primary endpoint. HARLIKU’s approval offers a long-awaited option to address the significant disease burden, including joint damage and decreased mobility, in AKU patients.

The second quarter of 2025 saw significant FDA approvals, enhancing treatment options for rare and chronic diseases and advancing precision medicine. Notable approvals included inebilizumab for immunoglobulin G4-related disease and nitisinone for alkaptonuria, addressing long-standing unmet needs. New therapies like atrasentan for IgA nephropathy and beremagene geperpavec for recessive dystrophic epidermolysis bullosa introduced innovative solutions in nephrology and dermatology. Additionally, approvals in respiratory and infectious diseases, such as mepolizumab for eosinophilic COPD and clesrovimab for RSV prevention, highlighted a trend toward targeted therapies.

Q2 2025 saw new therapies approved for a number of rare disease indications, multiple of which serve as the first disease-modifying therapies in the landscape.

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.

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Q2 2025 Recap: 7 Top FDA Approvals

Robert Sidbury, MD, MPH, is the division head of dermatology at Seattle Children's Hospital and a professor of pediatrics at the University of Washington School of Medicine.

 was issued by the American Academy of Dermatology (AAD), adding to the guidelines for topical and systemic 

 treatments in adults, Robert Sidbury, MD, MPH, spoke with 

 about the update and its relevance to clinicians and patients.

Sidbury is known for his role as a professor in the Department of Pediatrics at the University of Washington School of Medicine and as chief of the Division of Dermatology at Seattle Children’s Hospital. Sidbury’s multidisciplinary workgroup recently conducted a systematic review that resulted in this update by the AAD, with the investigators having implemented the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach for assessing evidence on recently approved drugs.

Significance of AAD Guideline Updates for Atopic Dermatitis, with Robert Sidbury, MD, MPH

“It had a lot to do with just how far down the road the studies [we evaluated] were,” Sidbury explained. “If you look at the National Eczema Association website, it is just a wonderful resource. It’s a patient advocacy group, but it is also a fabulous resource for providers, for journalists, for anyone interested in this space…You can go to a tab on their ‘Research’ page, which lists all of the clinical trials and their various stages of development, phase 1, phase 2, phase 3, and beyond. If you're in phase 3 development, you've passed some significant hurdles, and though it does not mean you'll be granted FDA approval, it is a significant distance down the road to having a drug you can prescribe.”

The decision to include this update, specifically regarding 4 newly US Food and Drug Administration (FDA)-approved treatments for atopic dermatitis, was the result of the level of research supporting each of their uses. The therapies were roflumilast cream 0.15%, tapinarof cream 1%, lebrikizumab, and nemolizumab (with topical therapy), with each being recommended by the AAD for physicians to integrate into clinical practice.

Sidbury noted that this update allows clinicians to have more options for patients who are prone to various side effects. Sidbury used the examples of dupilumab and Janus-Kinase (JAK) inhibitors to describe scenarios in which clinicians may be able to make informed decisions with more alternatives.

“Dupilumab, for instance, and other IL-13 category blockers, can have conjunctivitis or irritation of the eyes that is non-infectious. It's an inflammatory conjunctivitis,” Sidbury said. “But if that patient before you, and you're talking about various options, has a really bad history of conjunctivitis or other ocular disease, not an absolute contraindication to those medications…you'd want to review all of the options with that patient before choosing that one. Similarly, the JAK-inhibitors, another class of medication that is newer, have a boxed warning with various conditions and concerns that may always be important to discuss with patients, but may, given that particular patient's history and comorbidities, make that class of medications either a good choice or not.”

To find out more about the AAD’s atopic dermatitis guideline changes, view the full interview video posted above.

The quotes in this summary were edited for the purposes of clarity.

Sidbury has reported serving on Pfizer’s advisory board, for which he receives honoraria; acting as an investigator for Brickell Biotech and Galderma USA, with support through grants and research funding; serving as a principal investigator for Regeneron, also receiving grant and research support; and working as a consultant for Galderma Global and Microes, with compensation provided or, in some cases, not received.

Smith T. 4 New Recommendations for Atopic Dermatitis Management, with Robert Sidbury, MD, MPH. HCPLive. July 3, 2025. Accessed July 7, 2025. 

https://www.hcplive.com/view/4-new-recommendations-atopic-dermatitis-management-robert-sidbury-md-mph

Davis DMR, Frazer-Green L, Sidbury R, et al. Focused update: Guidelines of care for the management of atopic dermatitis in adults. J Am Acad Dermatol. 2025 Jun 17:S0190-9622(25)02125-5. 

Videos

Following the AAD guideline update on atopic dermatitis treatments, Sidbury speaks to the significance of the guideline recommendations for patients and clinicians.

Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

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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.

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.

In this recap of 7 FDA updates and 2 interview spotlights in allergy from the first half of 2025, we review important advances in 

care. At the 2025 American Academy of Allergy, Asthma, & Immunology (AAAAI) in San Diego, oral immunotherapy showed promise for peanut allergy in young children, and tezepelumab improved nasal polyp severity in CRSwNP.

US Food and Drug Administration (FDA) activity included the acceptance of Anaphylm’s epinephrine film NDA, the approval of garadacimab-gxii for HAE, and new warnings for cetirizine. Additional approvals expanded access to omalizumab biosimilars, pediatric HAE treatment, and a needle-free option for pediatric anaphylaxis.

2 Allergy Interviews on Phase 2 or 3 Data

Tezepelumab Lowers Nasal Polyp Severity in CRSwNP During Phase 3 WAYPOINT, with Joseph Han, MD

WAYPOINT on Tezepelumab for Nasal Polyps 

In the phase 3 WAYPOINT trial, tezepelumab significantly reduced nasal polyp severity and nasal congestion in patients with CRSwNP. The treatment lowered the need for surgery by 92% and improved symptoms like loss of smell and quality of life scores, showing early and sustained benefit over 52 weeks.

Oral Immunotherapy Shows Promise for High Threshold Peanut Allergy, with Scott Sicherer, MD

At AAAAI 2025, Scott Sicherer, MD, from Mt. Sinai School of Medicine, presented phase 2 data showing that 100% of children with high-threshold peanut allergy on oral immunotherapy tolerated 9043 mg of peanut, versus 10% in the avoidance group. The study highlights a promising, simple treatment option—using store-bought peanut butter under allergist supervision.

FDA Approves Factor XIIa-Targeting Garadacimab-gxii (ANDEMBRY) for HAE Attacks

The FDA approved garadacimab-gxii (ANDEMBRY), the first treatment targeting factor XIIa to prevent hereditary angioedema (HAE) attacks in patients aged ≥ 12 years. In the VANGUARD trial, it reduced HAE attacks by over 99%. The once-monthly, citrate-free injection offers a convenient, effective option for long-term HAE management with a strong safety profile.

FDA Approves First Interchangeable Biosimilar for Omalizumab

The FDA approved omalizumab-igec (OMLYCLO) as the first interchangeable biosimilar to Xolair for asthma, CRSwNP, food allergy, and chronic spontaneous urticaria. Phase 3 data confirmed its bioequivalence, safety, and efficacy, offering a more affordable treatment option to expand patient access and reduce healthcare costs.

FDA Approves 1 mg Neffy Nasal Spray for Pediatric Anaphylaxis

The FDA approved 1 mg neffy epinephrine nasal spray for children aged 4+ weighing 15–30 kg, offering a needle-free alternative for pediatric anaphylaxis. This user-friendly design may reduce hesitation, improve adherence, and enhance emergency treatment outcomes. Availability is expected by May 2025.

FDA Accepts Epinephrine (Anaphylm) Sublingual Film NDA for Type 1 Allergic Reactions

The FDA accepted the NDA for Anaphylm, a needle-free epinephrine sublingual film for severe allergic reactions, with a target decision date of January 31, 2026. Clinical data showed rapid symptom relief and no serious adverse events. If approved, Anaphylm could transform anaphylaxis care with its portable, easy-to-use design.

FDA Accepts BioCryst’s NDA for Berotralstat Oral Granules in Children With HAE

The FDA accepted BioCryst’s NDA for berotralstat oral granules to prevent HAE attacks in children aged 2–11 years, granting priority review with a target decision date of September 12, 2025. If approved, it would be the first oral prophylactic therapy for HAE in children under 12 years.

Palforzia Now Available in US for Children Aged 1 – 3 Years with Peanut Allergy

Palforzia is now available in the US for children aged 1–3 years with confirmed peanut allergy, addressing a critical unmet need. FDA approval, based on the successful POSEIDON trial, supports early oral immunotherapy to desensitize young children and help prevent peanut allergy progression during immune development.

FDA Warns About Rare, Severe Itching After Stopping Cetirizine or Levocetirizine

The FDA is adding warnings to cetirizine and levocetirizine labels after identifying rare cases of severe itching (pruritus) upon stopping long-term use. Most of the 209 global cases occurred in the US. Patients should be informed of this risk before starting treatment, especially for chronic use.

Recent advancements in allergy care include promising results from oral immunotherapy for peanut allergies in children and tezepelumab's efficacy in reducing nasal polyp severity in CRSwNP. The FDA has approved several treatments, including garadacimab-gxii for hereditary angioedema and a biosimilar for omalizumab, enhancing treatment options and accessibility. Additionally, a needle-free epinephrine nasal spray for pediatric anaphylaxis has been approved. New warnings for cetirizine highlight potential severe itching upon discontinuation. These developments underscore significant progress in allergy management and patient care.

Key FDA approvals, clinical trial insights, and expert commentary in allergy care from the first half of 2025.

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7 Allergy FDA News and 2 Interview Spotlights from First Half of 2025

Abigail Brooks is an assistant 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 second quarter of 2025 brought a flurry of regulatory activity and major clinical trial updates underscoring the rapidly evolving landscape in 

focal segmental glomerulosclerosis (FSGS)

, a string of FDA actions—including multiple Priority Review designations, a novel autoinjector approval, and an accelerated approval for a new class of therapy in IgAN—signal increasing momentum for therapeutic innovation across a range of kidney diseases.

62nd European Renal Association (ERA 2025) Congress

 served as a showcase for emerging data that could shape future standards of care. Highlights included 52-week results from VALIANT supporting pegcetacoplan’s benefit in C3G/primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), CONFIDENCE trial findings backing dual initiation of finerenone and empagliflozin in 

, and sibeprenlimab’s 51% proteinuria reduction in IgAN.

Here’s a recap of what made headlines in Q2 of 2025:

FDA Accepts Pegcetacoplan (Empaveli) sNDA for C3G, IC-MPGN

Starting Q2 on a high note, on April 1, 2025, Apellis Pharmaceuticals announced the FDA accepted and granted Priority Review designation to the Company’s supplemental New Drug Application (sNDA) for pegcetacoplan (Empaveli) for C3G and IC-MPGN. Supported by positive 26-week results from the phase 3 VALIANT trial, a Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2025, has been assigned.

Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy

The next day, on April 2, 2025, the FDA granted accelerated approval to atrasentan (Vanrafia), a once-daily, non-steroidal, oral treatment, for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression. Notably, the decision marked the FDA’s first approval for a selective endothelin A receptor antagonist for reducing protein in IgAN and came without any requirement for a Risk Evaluation Mitigation Strategy (REMS) program for use.

FDA Accepts Sparsentan (Filspari) sNDA for Focal Segmental Glomerulosclerosis

On May 15, 2025, the FDA accepted Travere Therapeutics’ sNDA for traditional approval of sparsentan (Filspari) for the treatment of FSGS, supported by results from the phase 3 DUPLEX Study and the phase 2 DUET Study. With the acceptance, the FDA assigned a PDUFA target action date of January 13, 2026, and indicated plans to hold an advisory committee meeting to discuss the application.

FDA Accepts, Grants Priority Review to Sibeprenlimab BLA for IgA Nephropathy

On May 27, 2025, the FDA accepted and granted priority review to Otsuka Pharmaceutical Development & Commercialization’s Biologics License Application (BLA) for sibeprenlimab for the treatment of IgAN, which was supported by data from the phase 3 VISIONARY trial and the phase 2 ENVISION trial. With the acceptance, the FDA assigned a PDUFA target action date of November 28, 2025.

FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus Nephritis

On June 24, 2025, the FDA approved a 200 mg/mL autoinjector of GlaxoSmithKline’s belimumab (Benlysta), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, for subcutaneous injection in patients ≥ 5 years of age with active LN who are receiving standard therapy. Initially approved for pediatric patients with active systemic lupus erythematosus in 2024, the approval of the belimumab autoinjector for LN offers patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home.

Pegcetacoplan Sustains Proteinuria Reductions in C3G, IC-MPGN at 52 Weeks

Extended data from the phase 3 VALIANT trial presented at ERA 2025 support the sustained efficacy and safety of pegcetacoplan (Empaveli) in patients with C3G or IC-MPGN, including adolescents and adults with native or transplanted kidneys. Specifically, the 52-week results show continued proteinuria reduction and eGFR stabilization in both treatment-naïve and crossover groups. An FDA decision on its approval for this indication is expected by July 28, 2025.

CONFIDENCE: SGLT2i and Finerenone Effective, Safe to Initiate Simultaneously in CKD

Findings from the CONFIDENCE trial presented at ERA 2025 suggest simultaneous initiation of finerenone (Kerendia) and empagliflozin (Jardiance) is well-tolerated and associated with a greater reduction in urinary albumin to creatinine ratio (UACR) than either therapy alone among patients with CKD and type 2 diabetes.

Kidney Compass: CONFIDENCE Trial at ERA 2025, with Rajiv Agarwal, MD, MS

Sibeprenlimab Halves Proteinuria in IgAN in Phase 3 VISIONARY Trial

Findings from an interim analysis of the phase 3 VISIONARY trial show use of sibeprenlimab was associated with a 51.2% reduction in proteinuria at 9 months relative to placebo therapy among patients with IgAN, according to an interim analysis of the phase 3 VISIONARY trial. With its BLA acceptance in May, a decision on sibeprenlimab’s approval for IgAN is expected by November 28, 2025.

Kidney Compass: Sibeprenlimab and the VISIONARY Trial, with Vlado Perkovic, MBBS, PhD, at ERA 2025

The second quarter of 2025 saw significant regulatory advancements and clinical trial updates in nephrology, highlighting therapeutic innovations in kidney diseases such as IgA nephropathy (IgAN), C3 glomerulopathy (C3G), lupus nephritis (LN), and focal segmental glomerulosclerosis (FSGS). Key FDA actions included Priority Review designations, accelerated approvals, and novel autoinjector approvals. The 62nd European Renal Association Congress showcased pivotal data, including pegcetacoplan's sustained efficacy in C3G, the CONFIDENCE trial's support for dual therapy in CKD, and sibeprenlimab's notable proteinuria reduction in IgAN.

The Q2 recap for nephrology spotlights key FDA decisions and top coverage from the 62nd European Renal Association Congress.

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.

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.

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.

Focal Segmental Glomerulosclerosis

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Chronic Kidney Disease

Q2 2025 Recap: Nephrology News and Updates

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Our recap of Q2 2025 in cardiology spotlights 3 FDA headlines, trial news, and new episodes of Don't Miss a Beat.

Dyslipidemia

Q2 2025 Recap: Cardiology News and Updates

Q2 2025 saw new therapies approved for rare rheumatological conditions and exciting research out of EULAR.

Q2 2025 Recap: 7 Rheumatology Updates to Know

According to recent research, more patients surviving heart diseases correlates directly to higher mortality rates for ischemic and chronic heart conditions.

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.

Mortality from Chronic Heart Disease Increases as Heart Attack Mortality Falls

Explore key advancements in endocrinology from Q2 2025, including FDA approvals and groundbreaking diabetes research shaping future treatments.

Type 2 Diabetes

Hormonal Disorders

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.

Endocrinology

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Q2 2025 Recap: Endocrinology News and Updates

Panelists discuss the growing role of blood eosinophils as a key biomarker in chronic obstructive pulmonary disease (COPD) management, highlighting their utility in guiding inhaled corticosteroid and biologic therapy decisions, the benefits of tracking longitudinal trends to improve accuracy, and the potential for integrating emerging biomarkers like FeNO to further personalize treatment despite current limitations.

Video Series

Peer Exchange

HCPLive® Peer Exchange panel discussions feature authoritative insights, opinions, and perspectives on important issues facing today's care professionals.

The Utility of Blood Eosinophils and Other Emerging Biomarkers in COPD Management

Panelists discuss how long-standing relationships between clinicians and patients are essential for early detection of cognitive decline, as trust and familiarity enable providers to notice subtle changes, facilitate open conversations, and collaboratively implement early interventions that help preserve independence amid an aging population.

Leveraging Patient Trust to Improve Outcomes in Alzheimer Disease

Panelists discuss the future of chronic obstructive pulmonary disease (COPD) management, emphasizing the need for long-term data on newly approved therapies, the development of refined biomarkers like FeNO and imaging tools to guide precision treatment, and the potential for earlier intervention with biologics—all aimed at advancing personalized care and altering the disease trajectory in high-risk patients.

Research Needs and the Future of COPD Treatment

Panelists discuss how primary care physicians rely on clinical observations, history-taking, and cognitive assessments—despite time and training limitations—to diagnose Alzheimer disease early, emphasizing the critical need for timely detection to enable effective interventions, lifestyle modifications, and to reduce long-term societal and health care burdens.

Early Identification and Diagnosis of Alzheimer Disease

A panelist discusses how dual orexin receptor antagonists (DORAs) offer a novel approach to treating insomnia by reducing wakefulness rather than inducing sedation, highlighting the importance of patient education on their gradual onset, distinct mechanism, and the need for consistent use to achieve long-term benefits.

Insights

 Insights page is a resource for professional video interviews with leading clinical experts and investigators across all specialties of medicine.

DORA Class for Treating Insomnia

A panelist discusses how future improvements in resistant hypertension management will focus on overcoming medication noncompliance through long-acting injectable treatments and device-based options like renal denervation, while emphasizing best practices including accurate out-of-office blood pressure measurements and systematic treatment protocols targeting 130/80 mmHg.

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