Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

 with topical roflumilast 0.3% is an effective and safe option for patients, with new data showing the drug outperforms vehicle across clinician- and patient-reported outcomes.

Bibek Shrestha, MBBS, from Tribhuvan University Institute of Medicine in Nepal, led a team of other investigators in authoring the systematic review and meta-analysis leading to these findings. The investigators highlighted the promise of roflumilast, a selective phosphodiesterase-4 (PDE-4) inhibitor, as a therapeutic agent addressing concerns over cutaneous inflammation.

“While individual randomized trials have demonstrated clinical improvement with topical roflumilast, there is no systematic review that summarizes evidence on efficacy and safety in patients…” Shrestha et al wrote.

 “Thus, we performed this systematic review and meta-analysis to evaluate the efficacy and safety of topical roflumilast 0.3% in patients with plaque psoriasis.”

Design and Findings on Topical Roflumilast

The investigative team systematically searched, from their inception through May 2025, the Embase, Cochrane CENTRAL, ClinicalTrials.gov, and PubMed databases. They had sought to identify eligible RCTs for their analysis. Two independent reviewers were asked to screen all RCT titles and abstracts. They would determine which research fulfilled predetermined criteria for full-text evaluation. Any notable disagreements were resolved by the team through consultation with a third reviewer.

In their analysis, Shrestha and coauthors focused on several clinical endpoints in these RCTs, including Investigator’s Global Assessment (IGA) or body-IGA success, which was defined as attainment of clear or almost clear skin with a minimum 2-grade improvement from baseline. They also looked at data related to Psoriasis Area and Severity Index thresholds (PASI-50, PASI-75, PASI-90), to scalp-IGA (S-IGA), to intertriginous-IGA (I-IGA), and to PSSI-75, a score suggesting a 75% Psoriasis Scalp Severity Index improvement.

Additional outcomes highlighted by the investigative team included Numeric Rating Scale (WI-NRS) success attainment, Worst Itch, 8-week Psoriasis Symptoms Diary (PSD) scores, and reported occurrences of adverse events (AEs). The team's statistical calculations were done via Review Manager. They measured heterogeneity across RCTs with the Higgins I² statistic.

Across a set of 5 RCTs, involving 1835 study participants, Shrestha et al pointed to results suggesting topical roflumilast 0.3% led to significant increases in the rates of IGA/body-IGA improvement at the 8-week mark (RR 4.19; 95% CI 2.49–7.04; 

 They also noted substantial increases in S-IGA success (RR 3.37; 95% CI 1.57–7.25; 

 = .002) as well as I-IGA success (RR 3.32; 95% CI 2.11–5.22; 

Superior outcomes resulting from treatment with roflumilast were observed in PASI-50, PASI-75, PASI-90, and PSSI-75 scores.

 Relative risks were shown by the investigators to range from 2.55 to 4.32 (all 

 < .00001). PSD score improvements (MD –25.34; 95% CI –31.77 to –18.92) and WI-NRS improvements (RR 2.12; 95% CI 1.74–2.60) were likewise found to be significant. AEs were identified more frequently among individuals being treated with topical roflumilast (RR 1.29; 95% CI 1.08–1.54; 

While Shrestha and colleagues' findings in this systematic review and meta-analysis provide strong evidence suggesting topical roflumilast 0.3% psoriatic signs and symptoms improvements compared with vehicle, additional research was described as necessary to fill remaining gaps in the data. Future assessments were highlighted as needed to prioritize direct comparisons between roflumilast and other established topical drugs, with the aim being more clearly defining any distinctions in efficacy and safety across various psoriasis therapies.

“Combined with the favorable tolerability profile of topical 0.3% roflumilast, these key findings highlight topical roflumilast's potential to effectively and safely address the therapeutic needs of psoriasis patients,” Shrestha and coauthors concluded.

AA Khattak, A Javed, UA Rahman, et al. Clinical Efficacy and Safety of Topical Roflumilast in Psoriasis: An Updated Systematic Review and Meta-Analysis of Randomized Controlled Trials. JEADV Clinical Practice 0 (2025): 1-13, 

Hatzelmann A, Morcillo EJ, Tenor H, et al. The preclinical pharmacology of roflumilast--a selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary disease. Pulm Pharmacol Ther. 2010 Aug;23(4):235-56. 

Articles

Topical roflumilast 0.3% has been shown to be an effective and safe treatment for plaque psoriasis, outperforming placebo in both clinician- and patient-reported outcomes. A systematic review and meta-analysis of five randomized controlled trials involving 1835 participants demonstrated significant improvements in various clinical endpoints, including Investigator’s Global Assessment and Psoriasis Area and Severity Index scores. While adverse events were more frequent with roflumilast, its favorable tolerability profile suggests it could effectively address therapeutic needs. Further research is needed to compare its efficacy and safety with other topical treatments.

This systematic review and meta-analysis looked at research on the efficacy and safety of topical roflumilast 0.3% in patients with plaque psoriasis.

Plaque Psoriasis

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

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Topical Roflumilast 0.3% Effective, Safe in Systematic Review of Psoriasis Data

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.

Credit: University of California, San Diego

Pharvaris announced that RAPIDe-3 met its primary endpoint, with deucrictibant relieving 

The phase 3, placebo-controlled RAPIDe-3 trial evaluated deucrictibant, an oral immediate-release capsule (20 mg), for the on-demand treatment of HAE. Investigators evaluated this novel bradykinin B2 receptor antagonist in 134 participants aged ≥ 12 years from 24 countries on 6 continents.

“Bradykinin B2 receptor antagonism is a proven and effective mechanism for treatment of bradykinin-mediated angioedema,” said lead investigator Marc A. Riedl, MD, professor of medicine and clinical director of the US Hereditary Angioedema Association (HAEA) Angioedema Center at the University of California, San Diego (UCSC), in a statement.

 “Injectable and oral on-demand therapies for HAE are available; however, unmet medical needs remain. The comprehensive and compelling outcomes of RAPIDe-3, specifically the fast treatment response and early complete symptom resolution, demonstrate the potential benefits of deucrictibant as an important on-demand treatment for people living with HAE.”

Riedl and colleagues assessed median time to treatment onset using the Patient Global Impression of Change (PGI-C); median time to substantial symptom relief using the PGI-C and Patient Global Impression of Severity (PGI-S); median time to complete symptom resolution using the PGI-S; and the percentage of attacks treated with a single capsule of deucrictibant. The sample included participants both on and off long-term prophylaxis; attacks of varying severity and across all body locations; and HAE subtypes, including type 1, type 2, and HAE with normal C1 inhibitor. This diverse population makes RAPIDe-3 highly representative and the first on-demand HAE study fully aligned with the Core Outcome Set recommended by the AURORA consensus.

Compared to placebo, participants on deucrictibant responded to the treatment quicker— within 1.28 hours, on average, vs > 12 hours (

 <.0001). Even minimal improvement, described as feeling “a little better,” counted as an onset of treatment response. Time to End of Progression 17.47 minutes for participants on deucrictibant vs 228.67 minutes for participants on placebo (

Participants treated with deucrictibant also experienced a shorter median time to substantial symptom relief on the PGI-C—rated as “better”—compared with placebo (2.85 hours vs > 12 hours; 

 <.0001). Time to substantial symptom relief by PGI-S4 ≥ 1-level improvement was 2.41 hours vs > 12 hours, respectively.

The median time to complete symptom resolution by PGI-S was significantly earlier with deucrictibant than placebo (11.95 hours vs > 24 hours; 

<.0001). Additionally, deucrictibant reduced attack burden: within 12 hours, 83% of attacks resolved with a single deucrictibant immediate-release capsule, and 93.2% of attacks required no additional rescue medication.

The study also showed that deucrictibant was well-tolerated with no treatment-related serious adverse events. The safety was consistent with completed and ongoing trials. Currently, investigators are conducting the ongoing RAPIDe-2 Part B, an open-label extension of deucrictibant for the on-demand treatment of HAE attacks.

“These clinically meaningful and statistically significant results demonstrate deucrictibant’s early-onset treatment response, fast symptom relief and resolution, and well-tolerated safety profile,” said Peng Lu, MD, PhD, chief medical officer of Pharvaris, in a statement.

 “This is an important step toward realizing deucrictibant’s potential to offer control of bradykinin-mediated angioedema attacks. With these data in hand, our team is working diligently to prepare for regulatory filings to enable access to this promising therapy.”

Pharvaris plans to submit a New Drug Application (NDA) for deucrictibant to the US Food & Drug Administration (FDA) in the first half of 2026. If approved, this would add yet another HAE treatment option for patients, building on the 

wave of HAE approvals seen in 2025, including garadacimab-gxii (Andembry), sebetralstat (Ekterly), and donidalorsen (Dawnzera)

, and setting the stage for the year ahead.

Pharvaris Announces Positive Topline Data from RAPIDe-3 Pivotal Study Confirming Potential of Deucrictibant for On-Demand Treatment of HAE Attacks - Pharvaris N.V. Pharvaris N.V. Published 2025. Accessed December 5, 2025. 

https://ir.pharvaris.com/news-releases/news-release-details/pharvaris-announces-positive-topline-data-rapide-3-pivotal-study

Soteres D, Tachdjian R, Manning M, et al. Rare Disease, Rapid Progress: FDA's HAE Approvals in 2025 Signal Changing Course. HCPLive. December 3, 2025. 

https://www.hcplive.com/view/rare-disease-rapid-progress-fda-hae-approvals-in-2025-signal-changing-course

Pharvaris' RAPIDe-3 trial demonstrated that deucrictibant effectively alleviates hereditary angioedema (HAE) symptoms within 90 minutes. This phase 3 study, involving 134 participants, highlighted the drug's rapid onset and symptom resolution compared to placebo. Deucrictibant, a bradykinin B2 receptor antagonist, showed significant efficacy in reducing attack duration and was well-tolerated with no serious adverse events. The promising results pave the way for a New Drug Application submission to the FDA in 2026, potentially expanding HAE treatment options alongside recent approvals.

Oral bradykinin B2 receptor antagonist resolved HAE attacks in under 90 minutes, with most patients needing only a single dose and no rescue medication.


Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Pharvaris’ Deucrictibant Provides Rapid Relief for HAE in Phase 3 RAPIDe-3 Trial

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.

In new research on patients with lupus nephritis, low-grade proteinuria does not predict improved renal outcomes or treatment responses, while 

 predicts renal function decline in patients who relapse.

Study investigator Nan Shen, MD, PhD, a distinguished professor of medicine at Shanghai JiaoTong University, and colleagues, aimed to “investigate the clinical characteristics, renal pathology treatment responses, and renal outcomes of lupus nephritis (LN) patients with different levels of baseline proteinuria.”

A previous 12-month study identified proteinuria as the strongest predictor of long-term renal outcomes in lupus nephritis compared with serum creatinine or urinary red blood cells.

 However, whether patients with low-grade proteinuria at baseline experience better clinical or histologic outcomes over time has remained unclear.

In lupus nephritis research, a 30%-40% decline in eGFR over several years is often used as a surrogate endpoint for long-term kidney function deterioration, allowing investigators to quantify clinically meaningful loss of renal function within a shorter follow-up period. In contrast, glomerulosclerosis represents a biopsy-based chronicity marker reflecting structural scarring present at baseline. Analyzing functional decline, eGFR loss, and structural damage associated with glomerulosclerosis can help clarify whether baseline proteinuria levels or chronicity features predict long-term renal outcomes.

In this longitudinal cohort study, investigators aimed to understand the association between proteinuria levels at baseline and clinical characteristics, renal pathology treatment responses, and renal outcomes of patients with lupus nephritis. The analysis incorporated chronicity markers such as glomerulosclerosis to identify predictors of long-term decline.

Shen and colleagues stratified patients by baseline proteinuria levels: low-grade (<1 g/24 h) and high-grade (≥1 g/24 h), in addition to disease onset status, incident or relapsing. At weeks 26 and 52, renal treatment responses were assessed by overall, complete, and primary efficacy renal response. By 156 weeks, investigators used Cox proportional hazards regression and Kaplan–Meier analyses to evaluate predictors of time to the first 30% and 40% eGFR decline as surrogate endpoints of long-term kidney disease progression.¹

The study included 239 patients with biopsy-proven lupus nephritis. Of these, 17.6% of participants had low-grade proteinuria levels (n = 42), and 82.4% had high-grade (n = 197). Additionally, investigators identified 51% of patients with incident lupus nephritis, and 49% had relapsing.

Upon analysis, investigators noted a decreased incidence of urinary sediments, an increased frequency of class V, and a decreased renal pathology activity index in the <1 group compared to the ≥1 group. These groups exhibited similar chronicity index, as well as similar overall remission rates at week 26 and 52.

At 156 weeks, investigators were able to observe an equivalent risk of 30% or 40% eGFR decline in patients with low-grade proteinuria compared with those with high-grade proteinuria. Investigators also evaluated renal pathology features. According to their findings, glomerulosclerosis independently predicted long-term renal deterioration in relapsing but not incident lupus nephritis.

“These results underscore the importance of early biopsy, personalized therapy, and close monitoring, supported by non-invasive biomarkers for risk assessment,” concluded investigators.

Shen Y, Peng J, Dai D, et al. Low‐Grade Proteinuria Does Not Predict Favorable Outcomes in Lupus Nephritis: A Longitudinal Cohort Study. Arthritis & Rheumatology. Published online November 28, 2025. doi:

Dall’Era M, Cisternas MG, Smilek DE, et al. Predictors of Long-Term Renal Outcome in Lupus Nephritis Trials: Lessons Learned from the Euro-Lupus Nephritis Cohort. 

Low-grade proteinuria in lupus nephritis patients does not predict improved renal outcomes or treatment responses, while glomerulosclerosis is a significant predictor of renal function decline in relapsing patients. A study involving 239 patients stratified by proteinuria levels and disease onset status found similar remission rates and chronicity indices between low-grade and high-grade proteinuria groups. However, glomerulosclerosis independently predicted long-term renal deterioration in relapsing lupus nephritis. These findings highlight the importance of early biopsy, personalized therapy, and non-invasive biomarkers for effective risk assessment and management.

A longitudinal cohort study shows a lack of correlation between decreased proteinuria levels and improved treatment, renal responses in patients. 


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.

Low-Grade Proteinuria Not Tied to Improved Renal Outcomes in Lupus Nephritis

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Throughout his tenure at MJH, Silas has been accountable for several organic launches of highly successful brands, including Targeted Oncology and NeurologyLive, and for quickly transforming acquisitions into high-functioning business units. Follow him on X @

New 52-week data from the phase 3 VERIFY study continue to strengthen the case for rusfertide as a potential first-in-class therapy for patients with polycythemia vera (PV). Presented at the 

, the updated results demonstrate sustained hematocrit control below 45%, high rates of phlebotomy ineligibility, and a consistent safety profile for the hepcidin mimetic across both the randomized and open-label portions of the trial.

"Rusfertide met the primary and all 4 secondary end points in VERIFY from baseline to week 32 and continued to provide durable, sustained control of hematocrit below 45% and phlebotomy ineligibility through week 52," lead investigator Andrew Kuykendall, MD, at Moffitt Cancer Center in the Department of Malignant Hematology, said during a presentation of the results. "After 52 weeks of treatment in VERIFY, rusfertide was well tolerated with a safety profile that was consistent with prior observations."

The VERIFY study enrolled patients receiving standard-of-care PV management, defined as phlebotomy with or without cytoreductive therapy, and randomized them 1:1 to rusfertide or placebo for 32 weeks (part 1a). After the primary end-point assessment window at weeks 20 to 32, patients in the placebo arm crossed over to receive open-label rusfertide plus standard therapy through week 52 (part 1b). Durability of hematocrit control and phlebotomy independence were the key measures in the extension period.

The newly reported findings show that patients maintained on rusfertide experienced continued benefit, and those who switched from placebo rapidly caught up. Among participants who received rusfertide throughout, the rate of phlebotomy ineligibility increased from 76.9% at week 32 to 84.1% at week 52. For patients who switched from placebo to rusfertide, the phlebotomy ineligibility rate rose from 32.9% to 77.9% during the same timeframe. Hematocrit levels declined quickly in the crossover cohort by week 52, both groups achieved similar levels of control.

"Rusfertide lowered hematocrit levels without exacerbating systemic iron deficiency," said Kuykendall.

During the randomized period (part 1a), rusfertide showed superiority over placebo across all major clinical outcomes. Hematocrit control below 45% was achieved in 62.6% of patients receiving rusfertide versus 14.4% on placebo (

 <.0001). Patients in the rusfertide arm required far fewer phlebotomies, with a mean of 0.5 versus 1.8 for placebo (

 <.0001). Patient-reported outcomes also favored rusfertide, including improvements in fatigue and symptom burden. On the PROMIS Fatigue SF-8a, patients receiving rusfertide reported a 1.78-point decline in fatigue compared with a slight increase in the placebo group.

Baseline characteristics were well balanced between arms in part 1a. In the extension, the median patient age was 57 years, and the majority were male. Nearly half of participants met criteria for high-risk PV, defined by age ≥60 years and/or a history of thromboembolic events. Use of cytoreductive agents remained consistent between study phases, with hydroxyurea as the most common therapy.

Physiologic markers tracked throughout the study demonstrated biologic activity consistent with hepcidin mimetic therapy. Ferritin levels remained low and unchanged for placebo recipients in the randomized phase and increased steadily once patients crossed over to rusfertide. Transferrin levels decreased while transferrin saturation and serum iron rose modestly, suggesting improved iron homeostasis without indications of worsening systemic iron deficiency. Leukocyte counts remained stable and platelet counts showed modest improvement in rusfertide-treated patients.

Safety findings remained favorable and aligned with earlier trial experience. At data cutoff, 86.7% of patients continued receiving open-label rusfertide. Discontinuations were infrequent: 7.5% during randomized treatment and 2.6% in the open-label phase. Most treatment-emergent adverse events (TEAEs) were grade 1 or 2. Injection-site reactions were the most common TEAE, occurring in more than half of rusfertide-treated patients during the randomized portion but decreasing notably between weeks 32 and 52 among those who continued treatment.

Secondary malignancies were less common in the rusfertide group than in the placebo group in part 1a (3 vs 8 events) and remained low in part 1b following crossover.

"Optimistically, you can see that some of the injection site reactions actually go down in the rusfertide arm from week 32 to 52, suggesting it may lessen over time," said Kuykendall.

A regulatory submission for rusfertide in PV is planned, supported by VERIFY and results from the REVIVE trial, in which rusfertide achieved a 60% response rate compared with 17% for placebo. VERIFY parts 2 and 3 will continue to evaluate long-term efficacy, safety, and treatment durability over multiple years. 

Results from REVIVE also support rusfertide's efficacy.

Kuykendall A, Bankar A, Pettit K, et al. Rusfertide or placebo plus current standard-of-care therapy for polycythemia vera: Durability of response and safety results through week 52 from the randomized controlled phase 3 VERIFY study. Blood. 2025;146(Supplement 1):abstract 81. doi:10.1182/blood-2025-8.

Kremyanskaya M, Kuykendall AT, Pemmaraju N, et al. Rusfertide, a Hepcidin Mimetic, for Control of Erythrocytosis in Polycythemia Vera. 

New data from the phase 3 VERIFY study reinforce rusfertide's potential as a first-in-class therapy for polycythemia vera (PV). The study demonstrated sustained hematocrit control below 45%, high phlebotomy ineligibility rates, and a consistent safety profile. Patients on rusfertide showed improved outcomes compared to placebo, with significant reductions in hematocrit levels and phlebotomy needs. The study also highlighted improvements in fatigue and symptom burden. Safety findings were favorable, with most adverse events being mild. A regulatory submission for rusfertide in PV is planned, supported by these findings.

Rusfertide shows promising results as a first-in-class therapy for polycythemia vera, demonstrating sustained hematocrit control and safety in recent studies.

Conference

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

Hematology

Rusfertide Maintains Hematocrit Control Through 52 Weeks in VERIFY

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.

While largely a quiet month for endocrinology, November 2025 was not without its important updates. There were no significant approvals from the 

, but glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have continued their advances into other condition centers such as nephrology and cardiology. Additionally, Novo Nordisk has had a rollercoaster month, between the failure of semaglutide to significantly reduce 

 has collected 5 of the most impactful headlines to come out of endocrinology in the last month. Check them out below to catch up on any news you might have missed.


Novo Nordisk’s Amycretin Demonstrates Superior Weight Loss Versus Placebo


On November 25, 2025, Novo Nordisk announced the success of their phase 2 clinical trial of amycretin, an investigative drug administered once-weekly subcutaneously or once-daily orally, in triggering weight loss and HbA1c reductions in patients with T2D. Based on these positive results, the company has also announced its intention to begin a phase 3 program at some point in 2026.


Investigative Amylin Agonist Eloralintide Proves Superiority to Placebo in Weight Management


Eloralintide displayed superior mean weight reductions versus placebo among adult patients with obesity and ≥1 weight-related comorbidity. The once-weekly selective amylin receptor agonist has the capacity to decrease calorie intake, which clinicians attribute to potential effects on satiety. Eloralintide is also under investigation both alone and with tirzepatide for weight management in adults with overweight or obesity and T2D.


Semaglutide Provides Cardiorenal Benefits in CKD With or Without Diabetes


A recent meta-analysis has highlighted a connection between semaglutide and favorable safety profiles in patients with 

, regardless of the presence of diabetes. During 5 randomized clinical trials, semaglutide was shown to lower the risk of major adverse cardiovascular events, kidney-related complications, and cardiovascular mortality. Investigators used these data to highlight the need for enhanced generalizability of GLP-1 data in nephrological diseases.


Diabetes Dialogue: Updates on Dexcom G7 and Semaglutide Pricing


In this episode of Diabetes Dialogue, cohosts Diana Isaacs, PharmD, and Natalie Bellini, DNP, discussed Dexcom’s announcement of the 15-day G7 sensor, which launched on December 1 through durable medical equipment channels and is planned to launch in pharmacies in January of 2026. The new sensor will integrate with the existing app platform and maintain the same accuracy profile, with a 15.5-day life via a built-in 12-hour grace period. Additionally, Isaacs and Bellini covered the significant price changes to Ozempic and Wegovy, with both drugs across all doses dropping to $199 for the first 2 months and $349 thereafter.


Diabetes Dialogue: Semaglutide Falls Short in Alzheimer Disease, Tirzepatide Shows Promise in T1D


In this episode, Isaacs and Bellini discuss Novo Nordisk’s negative results after the Evoke and Evoke+ phase 3 trials, both of which failed to show a reduction in disease progression speed in Alzheimer’s disease with oral semaglutide 14 mg. Although both trials saw improvements in related biomarkers, their failure to slow Alzheimer’s progression resulted in Novo Nordisk discontinuing a planned 1-year extension. However, these disappointing results are offset up the success of the TIRTLE phase 2 trial, which showed tirzepatide’s benefit in weight loss in adult patients with 

. Tirzepatide also improved glycemic control, reduced HbA1c, and decreased total daily insulin dose relative to placebo, all without significant adverse events.

November 2025 saw significant developments in endocrinology, despite no major FDA approvals. GLP-1 receptor agonists are expanding into nephrology and cardiology. Novo Nordisk experienced mixed results, with semaglutide failing to impact Alzheimer's progression, but amycretin showing promising weight loss outcomes in type 2 diabetes. Eloralintide demonstrated superior weight management, and semaglutide offered cardiorenal benefits in chronic kidney disease. Updates included Dexcom G7's launch and semaglutide pricing changes. Tirzepatide showed promise in type 1 diabetes, despite semaglutide's disappointing Alzheimer’s trial results.

Catch up with major trial results, key clinician insights, and more.

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

Type 1 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.

5 Endocrinology Headlines You Missed in November 2025

Naeem Bhojani, MD, associate professor and clinical researcher at the University of Montreal.

Videos

Explore the latest advancements in kidney stone treatment, focusing on suction technology and its impact on surgical outcomes and patient safety.

This Year In Medicine

Modernizing Kidney Stone Treatment: Devices, Data, and Clinical Impact

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

This FDA News Month in Review provides a round-up of regulatory decisions from November 2025.

FDA News

Heart Failure

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Cardiology

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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.

Ulcerative Colitis

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, IBS and IBD, Crohn's disease, and more.

Dyslipidemia

5 FDA Headlines You Missed in November 2025

Chari Cohen, DrPH, MPH, is the President of the Hepatitis B Foundation.

Cohen cites past failures with risk-based hepatitis B vaccination and voices concerns about the CDC APIC vote for individual-based decision-making.

Hepatology

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.

Clinical Concerns Over the ACIP Infant Hepatitis B Vaccine Decision, With Chari Cohen, DrPH, MPH

a psychiatrist and Chief Medical Officer at HMNC Brain Health

As the FDA strengthens AI standards after its recent meeting, a new AI-assisted genetic tool shows promise for pinpointing patients who may respond to a vasopressin blocker.

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.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

New Genetic Tool Shows Promise for Targeted MDD Treatment, With Hans Eriksson, PhD, MD

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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 8-3 APIC vote recommends individual-based decision-making for HBV vaccination in infants born to women who test negative for the virus.

CDC Changes Infant Hepatitis B Vaccine Recommendation

Decreased serum albumin levels can be a tool for predicting the risk of cancer and mortality in patients undergoing hemodialysis. 


Chronic Kidney Disease

Serum Albumin Levels Can Predict Increased Cancer Risk in Hemodialysis

Arun Chandra, MD, is an electrophysiology fellow at NewYork-Presbyterian Hospital and the clinical lead for Prevounce Health.

Remote patient monitoring revolutionizes cardiovascular care, enhancing preventive strategies, patient engagement, and outcomes through advanced technology and AI integration.

Evolving Evidence Supporting Remote Patient Monitoring in Cardiology

Findings suggest people with reduced kidney function have higher levels of Alzheimer’s biomarkers in their blood but not an increased risk of dementia.


Dementia and Alzheimer Disease

Alzheimer Disease condition center page, resources on the topics of medical news and expert insight into Alzheimer's can be found. Content includes articles, interviews, videos, podcasts, and breaking news on dementa and Alzheimer disease research, treatment, and drug development.

Impaired Kidney Function Linked to Alzheimer’s Biomarkers But Not Dementia

This randomized study explored a lower-cost, ambient-light, nonpolarized dermatoscope and its clinical utility in patient-performed teledermoscopy.

More Costly, Polarized Dermatoscope Results Compared to Nonpolarized Dermatoscope

The panel reviews the two major therapeutic strategies for treating ATTR-CM: transthyretin (TTR) silencers and stabilizers. Stabilizers work by binding to the TTR protein and preventing it from misfolding into amyloid fibrils, helping maintain the protein’s native structure. Silencers, by contrast, act at the genetic level to reduce the production of TTR protein in the liver through RNA interference or antisense mechanisms. Together, these approaches aim to reduce amyloid formation and slow disease progression.
The experts note that patients are often highly informed and eager to understand the differences between these therapies. They emphasize the importance of clear, patient-centered discussions that explain how the treatments work, why both options exist, and how therapy selection may depend on disease stage, phenotype, genetic background, and emerging clinical evidence. As research evolves, clinicians continue to refine how these mechanisms complement one another and how combination or sequential strategies may shape future care.


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