Viet Le, DMSc, PA-C, is a preventive cardiology PA at Intermountain Health and the former president of the Academy of Physician Associates in Cardiology.

Stephen Greene, MD, is an associate professor of medicine at Duke University School of Medicine and cardiologist at the Duke Clinical Research Institute in Durham, NC. Greene is a member of HCPLive's advisory board and co-host of Don't Miss a Beat, a podcast presented by Inside Cardiology.

Justin Ezekowitz, MD, is a professor of medicine at University of Alberta and a cardiologist at the University of Alberta Hospital and Mazankowski Alberta Heart Institute

Petra Mamic, MD, is a cardiologist and member of the Cardiovascular Institute at Stanford University.

Benjamin Hansen, MD, is a postdoctoral research fellow at the Department of Intensive Care at Copenhagen University Hospital - Rigshospitalet

Beyond Weight Loss: How GLP-1 RAs Established a Role in Cardiology in 2025

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) are one of the fastest-growing drug families in medicine today. From humble beginnings as a method of insulin and glucagon management in patients with type 2 diabetes (T2D), GLP-1s have expanded into hepatology, cardiology, and even ophthalmology. Their role as an anti-inflammatory agent, coupled with their weight loss capabilities, has rocketed GLP-1 RAs to one of the top drugs in the industry.

Today, GLP-1 RAs are the backbone of endocrinology. But in recent years, they’ve also become a core component in a variety of cardiovascular diseases. Given their management of obesity, which can lead to sharp increases in heart failure risk, coronary artery disease, and stroke, GLP-1s have taken on almost as prominent a role in cardiology as in their home turf of endocrinology.

In June of 2025, the American College of Cardiology issued a statement on weight management drugs, with a spotlight on GLP-1s. In it, they noted semaglutide and tirzepatide, which have been proven substantially more effective in reducing cardiovascular disease risk than lifestyle changes and with fewer risks than procedure-based interventions. Although prior guidance has suggested GLP-1s as a secondary or even tertiary treatment method, this year’s release encourages clinicians to consider them as first-line options for eligible patients.

Additionally, GLP-1s have received several key approvals from the US Food and Drug Administration (FDA), with oral semaglutide being granted an indication for the reduction of major adverse cardiovascular event risk in patients with T2D. Based on the SOUL trial, oral semaglutide’s approval marks the first oral GLP-1 medicine approved for a cardiovascular indication.

Tirzepatide, a dual GIP/GLP-1 agonist, also made significant progress towards an FDA approval of its own, with Eli Lilly’s SURPASS-CVOT trial indicating its efficacy in reducing MACEs in patients with T2D and established atherosclerotic cardiovascular disease. The head-to-head trial compared tirzepatide to dulaglutide and displayed the former’s superior efficacy; risk of heart attack, stroke, or cardiovascular death was substantially lower with tirzepatide.

However, in the face of such rapid advancement, some cardiologists encourage a more skeptical approach. Although great strides have been made in advancing cardiovascular outcomes with GLP-1 treatment, there are still factors limiting their reach. The most prominent of these issues is the number of clinical trials proving their efficacy. Many cardiologists have noted their hope – and expectation – for further case studies of GLP-1 RAs in the hopes of generating irrefutable evidence of their efficacy.

Editor’s Note: Le reports disclosures with Janssen, Pfizer, Novartis, Idorsia, Amarin, and Lexicon. Greene reports disclosures with Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals, Boehringer Ingelheim Pharmaceuticals, Cytokinetics, and others. Ezekowitz reports disclosures with Bayer, Merck, Amgen, Sanofi, Novartis, Cytokinetics, and others. Hansen and Mamic report no relevant disclosures.

Napoli N. American College of Cardiology Issues Guidance on Weight Management Drugs. American College of Cardiology. June 20, 2025. Accessed December 2, 2025. 

https://www.acc.org/About-ACC/Press-Releases/2025/06/20/14/11/American-College-of-Cardiology-Issues-Guidance-on-Weight-Management-Drugs

Novo Nordisk. FDA approves Novo Nordisk’s oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event. PR Newswire. October 17, 2025. Accessed December 5, 2025. 

https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-oral-semaglutide-for-cardiovascular-cv-risk-reduction-in-adults-with-type-2-diabetes-who-are-at-high-risk-including-those-who-have-not-had-a-prior-cv-event-302588022.html

Eli Lilly. Lilly’s Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefits in patients with type 2 diabetes and heart disease. July 31, 2025. Accessed December 5, 2025. 

https://investor.lilly.com/news-releases/news-release-details/lillys-mounjaro-tirzepatide-gipglp-1-dual-agonist-demonstrated

Videos

GLP-1 receptor agonists revolutionize treatment in cardiology, offering new hope for heart failure and related conditions beyond weight loss.

News

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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.

Atherosclerotic Cardiovascular Disease

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...

This Year In Medicine

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 

 specialists commonly believe antibiotic-first requirements for patients are outdated and often ineffective, new data suggest, and they support earlier use of biologics to improve outcomes.

These findings resulted from a questionnaire administered to 55 specialists in HS treatment, and the analysis of these data was authored by investigators such as Georgios Nikolakis, MD, PhD, of Brandenburg Medical School Theodor Fontane (MHB). Nikolakis and colleagues noted first-line biologic medications, as well as their potential advantages both for patients' health outcomes and long-term sustainability, required exploration.

Prior to this survey and analysis, they also highlighted the importance of examining the utilization of antibiotics in patients who are likely to switch to biologics, especially in light of antibiotic resistance and its worldwide growth.

“To address this, we sought insights from selected physicians, the majority of whom have been associated with the European Hidradenitis Suppurativa Foundation (EHSF), who possess specialized knowledge and experience with HS,” Nikolakis et al wrote.

 “Our objective was to better define their systemic therapy strategies and identify potential unmet needs in the prescription of antibiotics and biologics in their clinical practice.”

The investigative team provided an electronic survey to 55 HS specialists on July 20, 2024. Most of these individuals were also noted members of the European Hidradenitis Suppurativa Foundation (EHSF). The survey, submitted via Google Forms, requested its recipients to fill out the questionnaire within 40 days. The team's survey invitations were emailed to addresses provided by members upon their taking part in the EHSF. They involved clinicians from all countries in Europe to ensure broad geographic representation.

Those taking part as participants were categorized by Nikolakis and coauthors as either HS experts or future opinion leaders. Those specifically labeled as HS experts were defined as physicians who were over the age of 40 years with extensive clinical experience in HS management, a history of frequent peer-reviewed publications, and/or involvement in national or international clinical guidelines. Often, those taking part had held leadership roles in professional societies, had organized HS-focused workshops, or had contributed to large-scale educational initiatives aimed at advancing care for HS.

Those classified by the investigators as future opinion leaders were identified as clinicians typically under the age of 40 years who had actively engaged in emerging HS research. These subjects' involvement was demonstrated through recent poster presentations, first- or co-authored publications, or active participation in national or international HS congresses within the prior 3 years. The ages of both types of participants were reported by Nikolakis et al as mean ± SD, with statistical analyses being carried out via Jamovi Version 2.6.25.0.

There were 16 questions provided in this survey, with the investigative team seeking to assess systemic treatment prescribing patterns in HS, the real-world application of clinical guidelines, and any existing unmet needs in biologic prescriptions. Additionally, those involved as subjects were asked to provide 3 illustrative cases where they would consider initiating biologic treatment, either as monotherapy or alongside antibiotics, without following the previously required 3-month antibiotic course.

Among those invited as respondents, 23 out of 30 experts (77%) and 20 out of 25 future opinion leaders (80%) filled out the survey. This resulted in a total of 43 individuals taking part, representing 19 of the 22 invited European countries. Among those in the expert cohort, 39% were listed as female, compared with 55% of those in the future opinion leader cohort. These respondents' mean ages were 55.4 ± 7.8 years for the expert group and 36.5 ± 4.88 years in the future leader group (

In their evaluation of practice patterns, the team found adherence among 95% of respondents to licensing regulations recommending 10–12 weeks of antibiotics prior to the initiation of biologics. However, they also highlighted 81% who confessed to prescribing antibiotics despite anticipating insufficient response. Over half of the those responding to the investigators' survey reported patients' experiences of disease flares during antibiotic therapy.

Nikolakis and colleagues also found 77% supported initiating biologic drugs earlier in cases of persistent flares. They also noted 79% who preferred short-term biologic therapy over antibiotics for early-stage HS. Those included in the study highlighted specific clinical features, including rapidly progressing disease, comorbidities, and extensive involvement, as justifications for earlier biologic use.

“The findings underscore the need for a consensus statement defining upgrade criteria for biologics as a first-line therapy, potentially improving patient outcomes and reducing healthcare burdens,” they concluded.

Nikolakis G, Alpsoy E, Zouboulis CC, et al. Towards the development of upgrade criteria for the treatment of hidradenitis suppurativa with biologics. J Eur Acad Dermatol Venereol. 2025 Nov 13. 

Aggarwal R, Mahajan P, Johri AK, et al. Antibiotic resistance: a global crisis, problems and solutions. Crit Rev Microbiol. 2024 Sep;50(5):896-921. 

Articles

A recent survey of 55 hidradenitis suppurativa (HS) specialists suggests that the traditional antibiotic-first approach is outdated, with many advocating for earlier biologic use to improve patient outcomes. The survey, conducted among European HS experts and future opinion leaders, revealed that while most adhere to current guidelines, a significant number prescribe antibiotics despite expecting poor responses. The findings highlight the need for updated guidelines to prioritize biologics, especially in cases of persistent flares, rapidly progressing disease, and comorbidities, to enhance patient care and reduce healthcare burdens.

Investigators evaluated current prescription patterns for systemic HS medications among European HS specialists and opinions on criteria for biologic upgrades.

Hidradenitis Suppurativa

Hidradenitis Suppurativa 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 dermatology 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.

HS Specialists Express Support for Earlier Use of Biologics Among Patients

Ibrahim Gwarzo, MPH, MBBS, DrPH, is a research scientist at Nemours Children's Health.

Opioid Prescription for Sickle Cell Disease Misses Guideline Recommendation, With Ibrahim Gwarzo, MPH

 pain do not receive guideline-adherent opioid pain medication adequately, according to recent research from Nemours Children’s Health.

67th American Society of Hematology (ASH) Annual Meeting and Exposition

 in Orlando, Florida, by Ibrahim Gwarzo, DrPH, MPH, MBBS, a research scientist at Nemours Children’s Health, these data indicate an overall issue in opioid prescription during recurrent pain episodes, which are the leading cause of emergency department (ED) visits among patients with SCD.

The ASH has previously published guidelines for opioid dosage in patients with SCD; these emphasize the rapid initiation and frequent reassessment of tailored opioid dosing. Specifically, they indicated an ideal initiation time within 60 minutes of arriving in the ED. Additionally, in cases where second doses were necessary, the guidelines specify that they should be administered within 30 minutes of the first dose.

“There have been persistent reports of delays before receiving any form of pain intervention,” Gwarzo told 

 in an exclusive interview. “This is despite the clinical guidelines, which recommend swift evaluation and administration of pain medications for these patients.”

Gwarzo and colleagues analyzed de-identified electronic health records of patients from >200 health systems participating in EPIC’s Cosmos research platform. All ED visits with a primary International Classification of Diseases (ICD-10) diagnosis code indicating an SCD pain crisis where ≥1 opioid pain medication was administered were included. Those taking place before 2019 or after 2024 were excluded, along with visits with diagnosis codes of any SCD complication. The study’s primary outcome was the timeliness of ED opioid pain medication for acute, uncomplicated SCD pain, expressed as the percentage of guideline adherence for first and second opioid doses.

Investigators calculated guideline adherence as a percentage of overall visits where the first opioid dose was given within 60 minutes of arrival. For visits with multiple opioid doses, the second dose’s guideline adherence was calculated as the percentage of visits where the second dose was administered within 30 minutes of the first dose. Additionally, patient, visit, and facility factors were explored, including age, sex, type of healthcare setting, payer, and acuity level.

A total of 228 were included, with a total of 394,725 ED visits from 40,977 unique patients. The median age was 31 years (interquartile range [IQR] 24-38), and 55.2% of participants were female. Patients paid through public insurance for 75% of visits.

Across all visits, only 32.5% were guideline adherent for the first opioid dose (95% CI, 32.4-32.6%). For the 76.6% (n = 302,738) of visits with multiple doses, guideline adherence for the second dose was 9% (95% CI, 8.9-9.1%). Stratification by route of administration did not change adherence for the first dose, but investigators saw that orally administered opioids had higher guideline adherence at the second dose – 24.3% (95% CI, 23.7-24.8%) 0 compared to parental doses of 7.7% (95% CI, 7.6-7.8%) (

After univariate analysis, investigators saw that guideline adherence for the first dose was higher among patients aged ≤19 years (52%; 95% CI, 51.6-52.5%) compared to patients aged >19 years (29.6%; 95% CI, 29.5-29.8%) (

 <.001). This relationship held for the second dose. Additionally, male patients were more likely to receive guideline-adherent therapy compared to females for the first dose (36.9%; 95% CI, 36.7-37.1% vs 28.9%; 95% CI, 28.7-29.1%; 

 <.001) and the second dose (10.6%; 95% CI, 10.4-10.8% vs 7.7%; 95% CI, 7.6-7.9%; 

“There is a substantial gap we need to cover in terms of providing pain relief to patients in pain crises,” Gwarzo said. “Despite guidelines that have been around for nearly a decade, we are still falling behind for these patients, not providing enough pain relief for them in the emergency department.”

Editor's Note: Gwarzo reports a disclosure with the National Heart, Lung, and Blood Institute (NHLBI).

Gwarzo I, Dega HC, Brousseau D. Multicenter Evaluation of Guideline Adherence for the Timeliness of Pain Medication for Acute Sickle Cell Disease Pain. Abstract presented at the 67th American Society of Hematology Annual Meeting and Exposition. Orlando, FL. December 6-9, 2025.

Brandow AM, Carroll CP, Creary S, et al. American Society of Hematology 2020 Guidelines for Sickle Cell Disease: Management of acute and chronic pain. Blood Advances. 2020;4(12):2656-2701. 

Gwarzo discussed the shortcomings faced by many patients with SCD during pain crises, due to less frequent opioid prescription than guidelines recommend.

Hematology

Conference

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

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.

New research on the sex differences in adults with stage 5 

 suggests the female survival advantage observed in the general population may not apply to women with kidney disease, with females >55 years of age less likely to survive or receive a kidney transplant than their male counterparts.

In the general population, women are more likely to outlive men by a 5.8-year gap, according to a previous study. In about 72% of 528 species of mammals, females live about 13% longer. Whether this mortality advantage persists in patients with chronic kidney disease has been previously unexamined.

“To our knowledge, no population-based study has examined sex differences in mortality and treatment among individuals with incident stage 5 CKD. Prior studies have reported lower hazards of all-cause mortality and death without receiving KRT in female individuals with CKD compared with male individuals,” wrote study investigator, Christian Chan, PhD, postdoctoral associate at Cumming School of Medicine. “However, these studies were based on nephrology-referred cohorts with less advanced disease, limiting generalizability to individuals with stage 5 CKD and potentially introducing bias if referral patterns differ by sex.”

To address this gap in research, investigators conducted a retrospective population-based cohort study leveraging data from administrative, laboratory, and provincial kidney programs in Alberta, Canada. The primary outcome assessed was all-cause death, found from Alberta Vital Statistics. Investigators established the study exposure as sex at cohort entry.

To compare mortality rates, investigators stratified patients by 5-year age groups and calculated female-to-male mortality rate ratios for the patient cohort and the general population. Stage 5 CKD was defined as sustained eGFR <15 mL/min/1.73 m2 for > 3 months.

The study included 7506 adults ≥ 18 years of age with incident stage 5 CKD. In the cohort, patients were categorized into groups of 18 to 44, 44 to 54, 55 to 64, 65 to 74, 75 to 84, and ≥ 84 years of age.

In the cohort, 54.9% of participants were male (n = 4121), and 45.1% were female (n = 3385). Investigators included individuals whose legal sex might not reflect that assigned at birth (<0.1%). Female individuals met stage 5 CKD criteria at older ages than male individuals (median [IQR] age at first documentation of stage 5 CKD, 74 [61-83] years vs 70 [58-80] years), with similar baseline eGFR and qualifying period by sex.

In a median 7.9-year follow-up, female individuals with stage 5 CKD experienced increased excess mortality than male patients, particularly at younger ages. Compared with the general population, standardized mortality ratios (SMRs) among those 20 to 44 years were 47.5 (95% Confidence Interval [CI], 34.7-60.3) for females and 12.0 (95% CI, 8.3-15.6) for males. At 65 to 74 years, SMRs were 14.1 (95% CI, 12.8-15.4) for females and 8.5 (95% CI, 7.9-9.2) for males, and by ≥85 years, SMRs were similar: 4.2 (95% CI, 3.9-4.5) for females and 4.1 (95% CI, 3.7-4.4) for males. Female-to-male mortality rate ratios showed a reversal of the usual female survival advantage in younger patients and a reduction in those with stage 5 CKD.

At 5 years after a stage 5 CKD diagnosis, female patients had 58.9% (95% CI, 57.2-60.7) crude risks of all-cause mortality compared with 51.9% of males (95% CI, 50.3-53.5). Death without receiving KRT occurred in 39.9% of females (95% CI, 38.3-41.6) versus 28.3% of males (95% CI, 26.9-29.7). In female patients, 8.5% (95% CI, 7.5-9.5) received a transplant compared to 14.5% of males (95% CI, 13.4-15.7).

Upon age-stratified analyses, investigators observed increased mortality in females <55 years, with similar risks between sexes in older age groups. In adjusted analyses, investigators increased all-cause mortality in females <45 years, increased death without kidney replacement therapy in those 65-74 years, and lower dialysis hazards in females ≥55 years.

“These findings highlight the need for further research into the biological, structural, and societal factors influencing sex differences in treatment decisions and survival,1” concluded investigators.

Chan C, Sawhney S, Ahmed SB, et al. Sex Differences in Mortality and Receipt of Kidney Replacement Therapy Among Adults With Stage 5 Chronic Kidney Disease. 

. Published online November 17, 2025. doi:

https://doi.org/10.1001/jamainternmed.2025.5979

Why do women live longer than men? A study offers clues to close the gap. NPR. Published October 6, 2025. 

https://www.npr.org/2025/10/06/nx-s1-5558184/women-men-longevity-health-life-span

Research indicates that the female survival advantage seen in the general population does not extend to women with stage 5 chronic kidney disease (CKD). Women over 55 with CKD are less likely to survive or receive a kidney transplant compared to men. A study in Alberta, Canada, found that females with stage 5 CKD have higher mortality rates, especially at younger ages, and lower rates of kidney replacement therapy. These findings suggest a need for further investigation into the factors affecting sex differences in CKD treatment and outcomes.

In women with CKD, there are no general survival advantages compared to the male patient population. 


Nephrology

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

Chronic Kidney Disease

Women's Health

On the HCPLive women's health page, resources on the topics of medical news and expert insight into obstetrics, gynecology, and women's related health can be found. Content includes articles, interviews, videos, podcasts, and breaking news on women's health, and more.

Stage 5 CKD May Reverse Female Survival Advantage

Chelsie Derman is an associate editor for 

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

A recent phase 3 study showed that lumateperone 42 mg as an adjunctive to antidepressant therapy provided statistically significant improvement in depression symptoms and disease severity by day 43 among individuals with 

This long-term pivotal data follows the US Food & Drug Administration (FDA) approval of lumateperone as an adjunctive therapy for MDD, announced by Johnson & Johnson on November 6, 2025. Lumateperone, an oral, once daily atypical antipsychotic, targets 3 neurotransmitters simultaneously: serotonin, dopamine, and glutamate. The drug acts as a 5-HT2A antagonist and modulates dopamine by partially agonizing presynaptic D2 receptors while blocking postsynaptic ones. It also influences D1 signaling, indirectly enhances AMPA and NMDA glutamatergic activity, and exhibits some CERT-inhibitory effects.”

“This complex mechanism, which includes all these 4 mechanisms, is the reason why we have seen a strong efficacy for this in this patient population,” said first author Suresh Durgam, MD, the chief medical officer and executive vice president at Intra-Cellular Therapies, in the

Podcast episode, December 2025: “December 2025: Adjunctive Lumateperone in Patients With Major Depressive Disorder: Results From a Randomized, Double-Blind, Phase 3 Trial.”

Durgam and colleagues conducted a phase 3, randomized, double-blind, placebo-controlled trial to assess lumateperone 42 mg as an adjunctive to antidepressant therapy in patients with MDD. Primary and secondary outcomes included change from baseline to day 43 in MADRS total score and Clinical Global Impressions Scale severity (CGI-S) score. Safety measures included adverse events, extrapyramidal symptoms, laboratory assessments, and suicidal ideation and behavior.

The sample included adults aged 18 – 65 years old who had DSM-5-defined MDD, an inadequate response to 1 or 2 antidepressant therapies in the current depressive episode, and a Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 24. Participants were randomized 1:1 to receive evening doses of lumateperone 42 mg plus their current antidepressant (n = 242) or placebo plus antidepressants (n = 238) for 6 weeks. The antidepressant used was the most recent medication to which the participant had shown an inadequate response (<50% improvement).

The trial met the primary and secondary endpoints, with lumateperone plus antidepressants significantly improving MADRS total score (least squares mean difference [LSMD] versus placebo, −4.5; effect size, −0.56) and CGI-S score (LSMD, −0.5; effect size, −0.51) versus placebo plus antidepressants at day 43. The lumateperone arm also had significantly improved patient-reported depression compared to the placebo arm at day 43 (16-item Quick Inventory of Depressive Symptomatology-Self-Report, total score, SMD, −2.2; effect size, −0.45)

The study also showed that lumateperone plus antidepressants was generally well tolerated, though more patients on lumateperone discontinued treatment due to treatment-emergent adverse events (12.4% vs 0.8%). Common adverse events included dizziness, somnolence, dry mouth, nausea, diarrhea, and fatigue. Lumateperone had a minimal risk of extrapyramidal symptoms and suicidal ideation; both arms had similar levels of cardiometabolic abnormalities and weight gain.

“This is not new from the standpoint of other atypical antipsychotics have been approved by the FDA for this purpose,” said Ned Kalin, editor-in-chief of the 

and psychiatry department chair at the University of Wisconsin, in the podcast. He listed currently approved antipsychotics: neuropeprazole, brexpiprazole, preprazole, cryptozone, and the combination medication olanzapine/fluoxetine.

“So, we do have other agents in this class of drugs that are already shown and are approved by [the] FDA to help people with depression,” Kalin continued. “But this is another medicine, and it's really helpful for us because it's not identical to the other medications.”

Durgam S, Earley WR, Kozauer SG, et al. Adjunctive Lumateperone in Patients With Major Depressive Disorder: Results From a Randomized, Double-Blind, Phase 3 Trial. 

. 2025;182(12):1072-1082. doi:10.1176/appi.ajp.20250292

FDA approval of CAPLYTA® (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder. JNJ.com. Published November 6, 2025. https://www.jnj.com/media-center/press-releases/fda-approval-of-caplyta-lumateperone-has-the-potential-to-reset-treatment-expectations-offering-hope-for-remission-in-adults-with-major-depressive-disorder

December 2025: Adjunctive Lumateperone in Patients With Major Depressive Disorder: Results From a Randomized, Double-Blind, Phase 3 Trial. Apple Podcasts. Published December 2025. Accessed December 8, 2025. https://podcasts.apple.com/us/podcast/december-2025-adjunctive-lumateperone-in-patients-with/id253702215?i=1000739105366

A phase 3 study demonstrated that lumateperone 42 mg, when used as an adjunctive therapy to antidepressants, significantly improved depression symptoms and disease severity in patients with major depressive disorder (MDD) by day 43. Following FDA approval, lumateperone targets serotonin, dopamine, and glutamate neurotransmitters. The trial met primary and secondary endpoints, showing significant improvements in MADRS and CGI-S scores. While generally well-tolerated, lumateperone had a higher discontinuation rate due to adverse events. This adds to the list of atypical antipsychotics approved for MDD treatment.

Following its 2025 FDA approval, lumateperone 42 mg demonstrated meaningful reductions in MADRS and CGI-S scores in adults with major depressive disorder.

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.

Adjunctive Lumateperone Significantly Improves MDD Symptoms by Day 43 

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.

Announced by Cogent Biosciences, these data indicate bezuclastinib’s capacity for improving patient-reported symptoms of mast cell burden.

SUMMIT: Bezuclastinib Outperforms Placebo in Nonadvanced Systemic Mastocytosis

Abigail Brooks is an assistant managing editor for 

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

The approval of Ayrmid’s omidubicel-onlv makes it the first hematopoietic stem cell transplant therapy to treat patients with severe aplastic anemia.

Anemia

FDA News

FDA Approves Omidubicel-onlv (Omisirge) As First Cellular Severe Aplastic Anemia Therapy

Daniel Mallon, MD, is a pediatric gastroenterologist at Cincinnati Children’s Hospital.

Mallon explains the shared risks linking celiac disease and type 1 diabetes and why early screening improves outcomes.

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

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

Navigating Autoimmune Overlap in Celiac Disease, With Daniel Mallon, MD

Crawford Strunk, MD, is an associate staff member at the Cleveland Clinic.

Strunk highlights reduced length of stay and superior outpatient pain management due to palliative care in hospitalized patients.

Sickle Cell

Sickle Cell condition center page, resources on the topics of medical news and expert insight into sickle cell disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sickle cell research, treatment, and drug development.

Palliative Care Improves Outcomes in Patients with SCD, With Crawford Strunk, MD

A retrospective cohort in finerenone showed nearly 40% proteinuria reduction at 8 months and stable eGFR in patients with IgA nephropathy.


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.

Finerenone Shows Promise in IgAN: Reduced Proteinuria, Stable Kidney Function 

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.

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

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

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


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 @

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

Rusfertide Maintains Hematocrit Control Through 52 Weeks in VERIFY

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.

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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.

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