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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.

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

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

Articles

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.

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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.

The second quarter of 2025 brought a steady stream of momentum in cardiology, with developments spanning early-stage innovation, late-phase trial results, and new FDA approvals. This quarter’s recap includes 3 key regulatory milestones—including a major hypertension approval and a fast-tracked gene editing therapy—as well as 3 headline-making trial readouts that challenged, confirmed, or extended the evidence base in high-risk populations.

 delivered 3 episodes from the frontlines of ACC, Heart in Diabetes, and beyond—offering expert commentary on treatment sequencing, cardiorenal strategies, and emerging approaches in ATTR-CM. Here’s a look at what mattered most this past quarter in cardiovascular care.

FDA Grants Fast Track Designation to VERVE-102 Gene Therapy

On April 11, 2025, the FDA awarded Fast Track designation to Verve Therapeutics’ VERVE-102 gene editing medicine to lower low-density lipoprotein cholesterol (LDL-C) levels in individuals with hyperlipidemia and high cardiovascular risk. The regulatory agency cleared the Investigational New Drug (IND) application for VERVE-102 in March 2025, when the company provided interim data from the dose–escalation part of the Phase 1b Heart-2 trial.

FDA Accepts NDA Submission for Oral Semaglutide 25 mg

On May 2, 2025, Novo Nordisk announced the FDA accepted its NDA for a once-daily 25 mg oral formulation of semaglutide (Wegovy) for chronic weight management in adults with obesity or overweight. Based on Phase 3 OASIS 4 trial results, the pill showed significant efficacy in reducing weight in patients with at least one comorbidity. According to Novo Nordisk, this could become the first oral GLP-1 therapy approved for obesity treatment. The drug also aims to reduce cardiovascular risk in patients with established heart disease. The FDA decision is expected in Q4 2025.

FDA Approves Triple Combination Drug GMRx2 (Widaplik) for Hypertension Treatment

On June 9, 2025, the FDA approved GMRx2 (Widaplik), the first single-pill triple combination therapy—telmisartan, amlodipine, and indapamide—approved for initial treatment of hypertension in adults likely needing multiple drugs. Based on positive results from 2 phase 3 trials and the VERONICA study, Widaplik demonstrated superior blood pressure control and good tolerability. According to George Medicines, the pill's design aligns with global guidelines recommending early use of combination therapy. A US launch is expected in Q4 2025.

VERVE-102 Safely Cuts LDL-C Levels in Early Phase 1b Results

On April 14, 2025, Verve Therapeutics announced data from their phase 1b Heart-2 trial of VERVE-102 for the treatment of patients with heterozygous familial hypercholesterolemia (HeFH) and/or premature coronary artery disease (CAD). A single infusion of the in vivo gene editing medicine achieved dose-dependent reductions in blood PCSK9 and LDL-C, with a mean LDL-C reduction of ≥50% and a maximum decrease of nearly 70% at the highest dose.

Phase 3 Trial Results Announced for Sotatercept-csrk in Pulmonary Arterial Hypertension

On June 23, 2025, Merck announced positive topline results from the Phase 3 HYPERION trial, showing sotatercept-csrk (WINREVAIR) significantly reduced time to clinical worsening in newly diagnosed PAH patients at intermediate or high risk. Based on a composite primary endpoint, the trial met its goal, with additional benefits seen in walking distance, NT-proBNP levels, and functional class. According to Merck, these findings extend sotatercept’s evidence base to earlier-stage patients, building on prior success in advanced PAH. On July 02, 2025, Merck announced the FDA’s acceptance of their BLA for a label expansion, which was granted Priority Review.

ACHIEVE: Spironolactone Fails to Reduce Cardiovascular Risk in Dialysis Patients

On June 6, 2025, results from the ACHIEVE trial presented at ERA 2025 showed that spironolactone did not significantly reduce cardiovascular death or heart failure hospitalization in dialysis patients. Based on data from over 2,500 participants, the primary outcome occurred in 20.5% of the spironolactone group vs. 21.6% in the placebo group (HR 0.92; 

 = .35). According to investigators, the findings challenge earlier studies suggesting large cardioprotective benefits. Additionally, spironolactone was associated with a higher rate of severe hyperkalemia, occurring in 6.6% of patients.

During the second quarter of 2025, Don’t Miss a Beat released a trio of episodes, including a pair of in-person episodes from the floor at the American College of Cardiology and the Heart in Diabetes meeting. Check out our episode summaries below!

Treatment Sequencing in New Era of Heart Failure Management

In this episode recorded at ACC 2025, the hosts examine the expanding treatment landscape for HFpEF, advocating for early combination therapy using SGLT2 inhibitors, MRAs, and incretin-based drugs to improve outcomes. They debate rapid versus risk-based implementation, highlight phenotyping for tailored care, and discuss upcoming trials and the promise of fixed-dose combinations to enhance adherence.

CONFIDENCE Trial and Combination T2D, CKD Therapy at Heart in Diabetes 2025

In this episode, the hosts review findings from the CONFIDENCE trial showing that combination therapy with finerenone and empagliflozin significantly outperformed either drug alone in reducing albuminuria in patients with CKD and type 2 diabetes. They discuss the trial’s design, safety profile, and implications for rapid implementation strategies and future fixed-dose combination treatments in cardiorenal care.

Don't Miss a Beat: Navigating the ATTR-CM Care Landscape, With Ahmad Masri, MD

In this episode, the hosts and their guest discuss major advances in treating transthyretin amyloid cardiomyopathy, highlighting FDA-approved agents like tafamidis, acoramidis, and vutrisiran, while examining challenges such as residual risk, late-stage symptom limitations, and lack of head-to-head data. They also explore future strategies including amyloid-clearing therapies and early intervention trials like ACT-EARLY, which could shift the focus toward prevention in high-risk patients.

The second quarter of 2025 saw significant advancements in cardiology, including key FDA approvals and trial results. Notable regulatory milestones included the Fast Track designation for VERVE-102 gene therapy, the acceptance of an NDA for oral semaglutide, and the approval of the triple combination drug GMRx2 for hypertension. Trial updates highlighted the efficacy of VERVE-102 in reducing LDL-C levels, positive results for sotatercept-csrk in pulmonary arterial hypertension, and the lack of cardiovascular benefit from spironolactone in dialysis patients. Additionally, expert discussions on treatment strategies were featured in "Don't Miss a Beat" episodes.

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

Dyslipidemia

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...

Q2 2025 Recap: Cardiology News and Updates

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 brought critical developments in rheumatology and autoimmune disease, as the FDA advanced several high-impact therapies and new data emerged to support innovative treatments. Regulatory milestones included the first-ever approval of inebilizumab for immunoglobulin G4-related disease, a landmark for this underserved patient population, and expanded indications for upadacitinib in giant cell arteritis, offering clinicians new tools for managing complex inflammatory conditions. Meanwhile, late-stage trial successes for TNX-102 SL in fibromyalgia and deucravacitinib in psoriatic arthritis hinted at promising future options for patients facing chronic pain and joint disease.

Alongside these approvals and data readouts, advances in gout and lupus therapies underscored the ongoing evolution of targeted treatment strategies, with monthly pegloticase regimens showing feasibility for uncontrolled gout and belimumab reaffirming its role in systemic lupus erythematosus. However, an expansive analysis of rheumatoid arthritis trends painted a sobering picture of rising disease burden despite progress in treatment, highlighting the need for renewed global efforts in prevention and early intervention.

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

FDA Approves Inebilizumab (Uplizna) as First IgG4-RD Therapy for Adults


The FDA has approved inebilizumab-cdon (Uplizna) as the first treatment for adults with immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet need in this rare autoimmune condition. This approval offers a new therapeutic option for patients previously reliant on less targeted treatments.​

FDA Approves Upadacitinib, Expanding Treatment for Adults With Giant Cell Arteritis


Upadacitinib has received FDA approval for treating adults with giant cell arteritis, providing a new option for managing this inflammatory vascular disease. This expands the therapeutic arsenal for clinicians dealing with this challenging condition.​

New Data Support TNX-102 SL Efficacy Ahead of PDUFA

TNX-102 SL, a sublingual cyclobenzaprine formulation, showed significant efficacy in reducing pain and improving sleep disturbance in fibromyalgia patients in the phase 3 RESILIENT study, with benefits sustained over 14 weeks. The phase 1 PK study demonstrated that TNX-102 SL achieves higher dynamic peak cyclobenzaprine levels with reduced exposure to its active metabolite norcyclobenzaprine, which may contribute to more durable effects compared to oral formulations. If approved by its August 15, 2025 PDUFA date, TNX-102 SL could become the first new FDA-approved fibromyalgia therapy in over 15 years and a novel non-opioid analgesic option for this challenging chronic pain condition.

Phase 3 Deucravacitinib Trial Meets ACR20 End Point in PsA

The phase 3 POETYK PsA-1 trial demonstrated that deucravacitinib significantly improved joint and skin symptoms in adults with active psoriatic arthritis, meeting its primary endpoint with 54.2% of treated patients achieving ACR20 response at week 16 versus 34.1% on placebo. Key secondary endpoints were also met, including significant improvements in skin clearance, physical function, and quality of life measures, alongside evidence of inhibited radiographic progression. The safety profile of deucravacitinib was consistent with previous studies, with no new safety signals identified, supporting its potential as an oral, first-in-class TYK2 inhibitor for psoriatic arthritis management.

Higher Dose Pegloticase Q4W Feasible for Uncontrolled Gout

The phase 4 FORWARD trial suggests that once-monthly (Q4W) dosing of pegloticase at 16 mg or 30 mg, combined with methotrexate, can maintain serum urate control in most patients with uncontrolled gout, with 68-73% achieving sustained sUA responses through month 6. These findings indicate that less frequent pegloticase infusions could improve treatment logistics and adherence while maintaining comparable safety and efficacy to the established Q2W regimen. Importantly, infusion reaction rates were low and consistent with prior studies, supporting monthly pegloticase as a feasible alternative for patients struggling with the burden of biweekly therapy.

Belimumab Superior to Placebo in Yielding Systemic Lupus Erythematosus Responses

A meta-analysis of five Phase 3 trials has confirmed the efficacy of belimumab in systemic lupus erythematosus (SLE) using the BICLA responder index. The pooled analysis of over 3000 patients showed significantly higher BICLA response rates with belimumab versus placebo, particularly in those with high disease activity or serologic markers. The therapy was also more effective when combined with antimalarials, reinforcing its clinical utility in SLE management.

Rheumatoid Arthritis Burden Has Surged Over Last 30 Years

A large AI-driven analysis of rheumatoid arthritis (RA) trends across 953 global locations revealed a 13.2% rise in RA incidence since 1990, affecting 17.9 million people in 2021, with a shift toward younger populations. While age-standardized RA mortality dropped by 32.7% since 1980, global RA-related DALYs nearly doubled, highlighting an expanding burden despite medical advances. The study also pinpointed local hotspots—like West Berkshire, UK, with the highest incidence—and demonstrated that targeted interventions, such as smoking reduction, could substantially lower RA burden, emphasizing the importance of localized strategies beyond socioeconomic status alone.

The second quarter of 2025 saw significant advancements in rheumatology and autoimmune disease treatments, with the FDA approving inebilizumab for IgG4-related disease and expanding upadacitinib's indications for giant cell arteritis. Promising late-stage trial results for TNX-102 SL in fibromyalgia and deucravacitinib in psoriatic arthritis suggest future therapeutic options. Advances in gout and lupus therapies, such as monthly pegloticase regimens and belimumab, highlight evolving targeted strategies. Despite these developments, a global analysis of rheumatoid arthritis trends underscores the rising disease burden, necessitating renewed prevention and early intervention efforts.

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

Pulmonology

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Q2 2025 Recap: 7 Rheumatology Updates to Know

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.

Although the last 50 years have seen a decrease in 

 deaths, chronic disease mortality has concurrently risen in a trade-off from more patients surviving events such as heart attacks.

According to a recent study, heart disease accounted for 41% of all deaths in the US in 1970; by 2022, it accounted for 24% of all deaths. The proportion of deaths caused by acute myocardial infarctions (AMI) dropped by almost 90% during this period. However, chronic heart diseases, such as 

, hypertensive heart disease, and arrhythmias, are rising substantially in the American population.1

“People are now surviving these acute events, so they have the opportunity to develop these other heart conditions,” said Sara King, MD, a medical resident of Stanford University of Medicine and lead author of the study.1

Investigators collected data from the National Vital Statistics System Centers for Disease Control and Prevention Wide-Ranging Online Data for Epidemiologic Research database, examining adults ≥ 25 years of age in the US from 1970 to 2022. Investigated outcomes included absolute number and age-adjusted mortality of total heart disease, ischemic heart disease, and other subtypes.2

During the indicated time, the US population > 25 years of age increased from 108.9 million to 229 million. Life expectancy likewise increased from 70.9 years to 77.5 years. The National Vital Statistics System recorded a total of 119,152,492 deaths, with 37,276,835 (31%) attributed to heart disease. In 1970, 733,273 heart disease deaths were recorded, of which 666,257 (91%) were ischemic and 67,016 (9%) were from other diseases. In 2022, investigators found 701,443 heart disease deaths, of which 371,360 (53%) were ischemic and 330,083 (47%) were from other heart diseases.2

Age-adjusted mortality for AMI also decreased by 89%, from 354 per 100,000 in 1970 to 40 per 100,000 in 2022. Average annual percentage change (AAPC) for AMI was -4.2% (95% CI, -4.3 to -4.1) from 1970 to 2022. Age-adjusted mortality for chronic ischemic heart disease fell by 71%, from 343 per 100,000 to 98 per 100,000. AAPC for chronic ischemic heart disease was -2.5% (95% CI, -2.6 to -2.4).2

Notably, investigators also saw age-adjusted mortality for other heart disease subtypes increase by 81%, from 68 per 100,000 to 123 per 100,000. AAPC for other heart disease subtypes was 1.2% (95% CI, 1.1 to 1.2). Heart failure, hypertensive heart disease, and arrhythmia had the greatest mortality increases, with age-adjusted mortality rising from 13 to 32 per 100,000 (146% increase), 16 to 33 per 100,000 (106% increase), and 2 to 11 per 100,000 (450% increase).2

Additionally, the rise in non-ischemic heart disease deaths reflects a rise in risk factors including obesity, diabetes, hypertension, and physical inactivity, according to King and colleagues. Roughly 50% of adults have diabetes or pre-diabetes, and 40% have obesity.1

While investigators noted the reduction in heart disease mortality over the last 50 years may be indicative of success in medical and public health interventions, they also indicated the emerging challenges presented by chronic ischemic heart disease and similar conditions. They suggest several possible explanations for the shift; interventional methods to reduce mortality from AMI, improvement in cardiac imaging, and the development of beta blockers, renal-angiotensin-aldosterone system inhibitors, and others.2

“We have so many tools in our toolbox now, but still, there’s a lot more that can be developed and improved,” King said. “I hope the numbers just keep getting better.”1

Standford Medicine. As fewer Americans die from heart attacks, more succumb to chronic heart disease. Eurekalert! June 25, 2025. Accessed July 2, 2025. 

https://www.eurekalert.org/news-releases/1088540

King SJ, Wangdak Yuthok TY, Bacong AM, et al. Heart disease mortality in the United States, 1970 to 2022. Journal of the American Heart Association. 2025;14(13). doi:10.1161/jaha.124.038644

Over the past 50 years, heart disease mortality in the US has decreased, with acute myocardial infarction deaths dropping significantly. However, chronic heart diseases like heart failure and hypertensive heart disease are on the rise due to increased survival from acute events. The study attributes this shift to improved medical interventions and highlights the growing impact of risk factors such as obesity and diabetes. Despite advancements, the rise in chronic heart disease mortality presents new challenges, emphasizing the need for continued development of medical tools and strategies.

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

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Mortality from Chronic Heart Disease Increases as Heart Attack Mortality Falls

The second quarter of 2025 brought meaningful developments in endocrinology, from FDA actions to clinical breakthroughs spotlighted at major meetings. Several regulatory milestones signaled progress for patients across the spectrum of endocrine disorders, including expanded access to CGM technology, new formulations for adrenal insufficiency, and a broader treatment label for Cushing’s syndrome.

Novo Nordisk’s NDA for 25 mg oral semaglutide also marked a potential turning point in obesity care, with the first oral GLP-1 formulation for weight management now under review. Meanwhile, June’s ADA Scientific Sessions capped the quarter with a surge of new data on incretin therapies, obesity drugs, and diabetes technology—many with practice-changing potential.

Here’s a look back at the most impactful regulatory updates and conference highlights shaping the future of endocrine care.

On April 10, 2025, the FDA cleared Dexcom’s G7 15-day continuous glucose monitoring (CGM) system for adults with diabetes, making it the longest-lasting and most accurate CGM approved in the U.S. Based on clinical data showing a MARD of 8.0%, the G7 15 Day demonstrated excellent accuracy and user satisfaction. According to Dexcom, the system offers features like Apple Watch integration, waterproof sensors, and extended wear with a 12-hour grace period for sensor changes. The company plans to ensure compatibility with insulin pump systems ahead of its US launch in late 2025.

FDA Approves Label Expansion for Osilodrostat for Cushing's Syndrome

On April 16, 2025, the FDA approved Recordati’s sNDA for osilodrostat (Isturisa), expanding its indication to include adults with endogenous Cushing’s syndrome who are not surgical candidates or for whom surgery was not curative. Previously approved only for Cushing’s disease, the broader label is supported by data from the LINC 3 and LINC 4 trials showing sustained cortisol reduction and clinical improvement. According to Recordati, osilodrostat offers a vital option for managing hypercortisolemia and preventing severe complications. 

On May 2, 2025, Novo Nordisk announced the FDA accepted its NDA for a once-daily 25 mg oral formulation of semaglutide for chronic weight management in adults with obesity or overweight and at least one comorbidity. Based on results from the 64-week OASIS 4 trial, the oral semaglutide demonstrated significant weight loss and cardiovascular risk reduction. According to Novo Nordisk, this could become the first oral GLP-1 therapy approved for obesity. If approved, it would expand individualized treatment options beyond injectable formulations. An FDA decision is expected in Q4 2025.

FDA Approves Hydrocortisone Oral Solution for Adrenal Insufficiency

On May 28, 2025, the FDA approved Eton Pharmaceuticals’ hydrocortisone oral solution (KHINDIVI) for pediatric patients aged 5 and older with adrenocortical insufficiency, marking the first liquid formulation approved for this use. Designed for accurate, individualized dosing, the 1 mg/mL solution helps patients who have difficulty swallowing pills. According to Eton, this ready-to-use formulation eliminates the need for pill-splitting and supports improved treatment outcomes during childhood development.

June 2025 also brought several groundbreaking trials and new updates in diabetes care at the 8th American Diabetes Association Scientific Sessions, which were held in Chicago, Illinois from June 20-23, 2025. With multiple sessions dedicated to late-breaking research, the meeting featured multiple simultaneous publications, including a slew of studies related to incretin therapies. To learn more about the meeting’s top news, check out this trio of articles recapping ADA 2025.

ADA 2025 Recap: 5 Studies on Obesity to Know

HCPLive Five at ADA Scientific Sessions 2025

Diabetes Dialogue: Semaglutide for MASH in ESSENCE Trial, With Arun Sanyal, MD

In this episode, the hosts discuss new Phase 3 data from the ESSENCE trial showing that once-weekly semaglutide 2.4 mg significantly improved liver outcomes and reduced weight in patients with MASH and stage 2 or 3 fibrosis. They speak with the trial’s lead author about semaglutide’s clinical impact, its potential as a future MASH treatment, and how it compares to the currently approved option, resmetirom.

In this episode, the hosts recap key moments from the 2025 AACE Annual Meeting, covering major plenaries, hands-on tech workshops, and the launch of a new diabetes technology certification program. They spotlight updates on GLP-1 safety, health equity, CGM innovations, and emerging trial data, while reflecting on the future of personalized diabetes care.

Diabetes Dialogue: Real-World Impact of iLet Bionic Pancreas, With Steven Russell, MD, PhD

In this episode, the hosts speak with the Chief Medical Officer of Beta Bionics about real-world outcomes from the iLet Bionic Pancreas, an FDA-cleared fully autonomous insulin delivery system requiring no user settings. They highlight its strong A1c-lowering effect, minimal hypoglycemia, and promise for underserved populations and primary care use, including off-label applications in type 2 diabetes.

Diabetes Dialogue: REDEFINE 1 and REDEFINE 2, with Timothy Garvey, MD, and Melanie Davies, MD

In this episode recorded at ADA 2025, the hosts break down results from the REDEFINE 1 and 2 trials showing that CagriSema delivered substantial weight loss and glycemic improvements in people with and without type 2 diabetes. They also discuss the drug’s safety, clinical relevance, and future in obesity care with trial investigators, highlighting upcoming studies like REDEFINE 3.

The second quarter of 2025 saw significant advancements in endocrinology, marked by FDA approvals and clinical breakthroughs. Key developments included the clearance of Dexcom's G7 15-day CGM system, expanded indications for osilodrostat in Cushing's syndrome, and the acceptance of Novo Nordisk's NDA for oral semaglutide for obesity. The ADA Scientific Sessions in June highlighted new data on incretin therapies and diabetes technology, with potential practice-changing implications. These updates underscore the evolving landscape of endocrine care, offering new treatment options and improved management strategies for various conditions.

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

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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.

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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.

How Clinicians can Prepare for the Future of Resistant Hypertension Care

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.

Sidbury highlights updates to previous guidelines on the management of atopic dermatitis using approved topical and systemic therapies.

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.

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.

4 New Recommendations for Atopic Dermatitis Management, with Robert Sidbury, MD, MPH

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.

This Q2 psychiatry recaps promising data of COMP360 for treatment-resistant depression, the expansion of clozapine access, and experts weighing in on new data and ethical debates.

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.

Q2 2025 Recap: Psychiatry Updates—TRD Breakthroughs, FDA News, Latest Podcast Episodes

June 2025 highlights groundbreaking advancements in endocrinology, featuring key insights from major conferences on diabetes, heart health, and kidney care.

Type 1 Diabetes

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Endocrinology Month in Review: June 2025

The Q2 recap for hepatology spotlights regulatory approvals, clinical trial updates, and the launch of HCPLive’s flagship hepatology podcast.

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.

Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!

Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Latest News

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Mortality from Chronic Heart Disease Increases as Heart Attack Mortality Falls

Q2 2025 Recap: Endocrinology News and Updates