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.

 approvals of esketamine for treatment-resistant depression, expanded-use buprenorphine and risperidone injectables, and BrainsWay’s Deep TMS for adolescents with major depressive disorder (MDD), offering clinicians new tools for personalized, effective care.

Clinical trials highlighted promising therapies: TEV-‘749 for schizophrenia, centanafadine and solriamfetol for ADHD, and MM120 (LSD) for generalized anxiety disorder, alongside expert insights on dermatologic comorbidities, psychiatry research updates, and ethical considerations in psychedelic treatments, shaping the evolving psychiatric landscape.

FDA Clears BrainsWay’s TMS Device for Adolescents with MDD Aged 15 to 21 Years

The FDA has cleared BrainsWay Ltd’s Deep TMS system for adolescents aged 15–21 years with MDD, announced on November 13, 2025. Supported by extensive real-world data, the noninvasive device delivers daily 20-minute sessions over 4–6 weeks, demonstrating significant reductions in depressive symptoms and comorbid anxiety.

FDA Approves Risperidone Extended-Release Injectable for Bipolar I Disorder

Announced on October 10, 2205, the FDA has approved Teva Pharmaceuticals’ UZEDY, a once-monthly, subcutaneous extended-release risperidone, for adults with bipolar I disorder. Using SteadyTeq™ technology, UZEDY provides controlled drug release, supporting maintenance therapy and addressing treatment gaps previously managed with oral or other long-acting formulations.

FDA Initiates Acetaminophen Label Change, Leucovorin Approval for Cerebral Folate Deficiency

The FDA has initiated a label change for acetaminophen, citing evidence linking prenatal use to increased autism and ADHD risk, while collaborating with GSK to approve leucovorin (Wellcovorin) for cerebral folate deficiency. Both actions aim to enhance awareness, improve safety, and expand treatment options for neurological conditions.

APhA, Coalition of Autism Scientists Cite Insufficient Data to Support Acetaminophen, Autism Link

FDA Approves Expanded Use of Buprenorphine Extended-Release Injection for OUD Treatment

Announced on February 24, 2025, the FDA has approved expanded use of Indivior’s SUBLOCADE, a buprenorphine extended-release injection for opioid use disorder, adding thigh, buttock, and upper arm injection sites. Label updates reduce induction to a single dose with one-hour observation, improving adherence and supporting flexible, patient-centered treatment.

FDA Approves Esketamine as First Monotherapy for Treatment-Resistant Depression

The FDA has approved Johnson & Johnson’s esketamine (SPRAVATO®) nasal spray as the first monotherapy for adults with treatment-resistant depression, which was announced on January 21, 2025. Phase 4 trials demonstrated rapid, superior improvement in MADRS scores within 4 weeks, providing a standalone option for patients unresponsive to oral antidepressants.

Teva Pharmaceuticals Submits NDA on TEV-‘749 for Schizophrenia to the FDA

Teva Pharmaceuticals submitted a New Drug Application (NDA) to the FDA for TEV-‘749, a once-monthly subcutaneous olanzapine extended-release injection for adult schizophrenia. Phase 3 SOLARIS trial data demonstrated efficacy, safety, and high patient, nurse, and physician satisfaction, offering a controlled-release alternative to oral olanzapine.

Otsuka Pharmaceuticals Submits NDA for Centanafadine to Treat ADHD in Children

Otsuka Pharmaceuticals submitted an NDA to the FDA for centanafadine, a novel NDSRI, for ADHD in patients aged 4–55 years. Four phase 3 trials showed significant, clinically meaningful improvements in ADHD symptoms with once-daily extended-release centanafadine, demonstrating a first-in-class mechanism and favorable tolerability.

J&J Submits sNDA to FDA for Lumateperone (CAPLYTA) to Prevent Schizophrenia Relapse

Johnson & Johnson submitted a supplemental NDA (sNDA) to the FDA for lumateperone (CAPLYTA) to prevent schizophrenia relapse. Phase 3 data showed a 63% reduction in relapse risk, characterized by high serotonin 5-HT2A receptor occupancy and lower dopamine D2 receptor occupancy, supporting its safety and long-term efficacy.

Solriamfetol Significantly Reduces ADHD Symptoms in Axsome’s Phase 3 Trial

Axsome Therapeutics’ FOCUS Phase 3 trial showed solriamfetol significantly reduced ADHD symptoms in adults, achieving a 45% mean reduction in AISRS scores versus placebo. Symptom improvement was observed as early as week 1, with a favorable safety and tolerability profile.

Single Dose of MM120 (LSD) Shows Lasting Anxiety Reduction in GAD: Phase 2b Results

A phase 2b trial by MindMed showed a single 100 μg dose of MM120 (LSD) significantly reduced anxiety in adults with GAD, with effects sustained through 12 weeks. Rapid improvements were seen by day 2, demonstrating dose-dependent efficacy and a favorable safety profile.

Single Dose of MM120 Shows Rapid Anxiety Reduction in GAD, With Maurizio Fava, MD

Silent Weight of Psoriasis: Addressing Depression, Anxiety, Stigma in Care

Patients with psoriasis are 1.5 times likely to develop depression, highlighting the importance of routine mental health screening. Experts like Eva Parker, MD, of Vanderbilt Health, emphasize addressing both visible skin symptoms and the emotional impact to improve overall patient well-being.

Medical Ethics Unpacked: Unique Ethical Challenges of Psychedelic Therapies

, hosts Steve Levine, MD, and Dominic Sisti, PhD, with guest Amy McGuire, JD, PhD, explore ethical challenges in psychedelic therapies, including consent, cultural integration, dosing, and clinical trial considerations.

Introducing The Gus Alva Perspective, with Gus Alva, MD

The Gus Alva Perspective, hosted by psychiatrist Gus Alva, MD, delivered biweekly expert insights on psychiatry, covering new treatments, research updates, and Southern California Psychiatry Meeting highlights to support clinicians in practice.

Articles

In 2025, significant advancements in psychiatry included FDA approvals for esketamine as a monotherapy for treatment-resistant depression, expanded-use buprenorphine, and risperidone injectables. BrainsWay's Deep TMS was cleared for adolescents with MDD. Promising clinical trials featured TEV-‘749 for schizophrenia, centanafadine and solriamfetol for ADHD, and MM120 (LSD) for generalized anxiety disorder. The FDA initiated acetaminophen label changes and approved leucovorin for cerebral folate deficiency. Ethical considerations in psychedelic treatments and the impact of dermatologic comorbidities on mental health were also highlighted.

In 2025, psychiatry saw major FDA approvals, novel treatments, and pivotal clinical updates that are transforming care for depression, ADHD, schizophrenia, and anxiety.

News

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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.

ADHD

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

Schizophrenia

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

​​Psychiatry in 2025: Year in Review

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.

, driven by rapid therapeutic innovation, evolving clinical guidelines, and a growing emphasis on long-term disease control and patient-centered care. Across inflammatory bowel disease, functional GI disorders, and colorectal cancer prevention, the field saw both an expansion of treatment options and greater clarity around how best to deploy them in clinical practice.

 dominated the year’s headlines, particularly with multiple US Food and Drug Administration (FDA) approvals that reshaped the Crohn’s disease (CD) and ulcerative colitis (UC) landscapes. New and expanded indications for IL-23 inhibitors reflected a shift toward high-efficacy, durable therapies, supported by increasingly robust long-term data and more flexible dosing strategies. At the same time, late-stage trial results for agents such as obefazimod and icotrokinra reinforced the depth of the IBD pipeline, while updated American Gastroenterological Association (AGA) guidelines emphasized earlier use of advanced therapies to improve outcomes.

Beyond IBD, 2025 delivered meaningful progress in broader gastroenterology care. The FDA approval of linaclotide for pediatric 

irritable bowel syndrome with constipation (IBS-C)

 addressed a long-standing unmet need, while new AGA guidance on gastroparesis and US Multi-Society Task Force on Colorectal Cancer (USMSTF) recommendations on bowel preparation highlighted continued efforts to standardize and optimize care. Together, these developments define 2025 as a year of consolidation and forward momentum that strengthened evidence-based practice while setting the stage for the next generation of GI innovation.

FDA Approves Mirikizumab (Omvoh) for Crohn’s Disease

On January 15, 2025, the FDA approved Lilly’s mirikizumab (Omvoh) for the treatment of adults with moderately to severely active CD, the therapy’s second approval in IBD since 2023 when it was approved as a first-in-class treatment for moderately to severely active UC. The approval made mirikizumab the first biologic treatment in more than 15 years to have disclosed 2-year phase 3 efficacy data in CD at the time of approval.

FDA Approves Guselkumab (Tremfya) For Crohn Disease

On March 20, 2025, the FDA approved guselkumab (Tremfya) for the treatment of adults with moderately to severely active CD based on data from multiple phase 3 trials, including the GALAXI trials, which found guselkumab outperformed ustekinumab (Stelara) for multiple endoscopic endpoints. With the approval, the agent boasts indications for both moderately to severely active CD and moderately to severely active UC.

FDA Approves Guselkumab (Tremfya) Subcutaneous Induction Regimen for Ulcerative Colitis

On September 19, 2025, the FDA approved a subcutaneous (SC) induction regimen of guselkumab (Tremfya) for the treatment of adults with moderately to severely active UC, making guselkumab the first and only IL-23 inhibitor to offer both SC and intravenous (IV) induction options for the treatment of UC and CD. The UC SC induction approval was based on results from the phase 3 ASTRO trial, which employed a treat-through design to evaluate the efficacy and safety of guselkumab SC induction therapy in adults with moderately to severely active UC who had an inadequate response or intolerance to conventional therapy and advanced therapies.

FDA Approves Single-Dose Formulation of Mirikizumab-mrkz for Ulcerative Colitis

On October 27, 2025, the FDA approved mirikizumab-mrkz (Omvoh) as a single-injection once-monthly maintenance regimen for adult patients with UC based on results from a phase 1 study comparing a single 200 mg/2 mL subcutaneous injection to a pair of 100 mg/1 mL injections and confirming the bioequivalence of the new 1-dose treatment to the previously approved 2-dose regimen.

FDA Approves Linaclotide (Linzess) Capsules for Pediatric IBS-C

On November 5, 2025, the FDA approved linaclotide (Linzess) capsules for pediatric patients ≥ 7 years of age with IBS-C, making it the first treatment approved for IBS-C in this patient population. The approval was supported by extrapolation of efficacy from adequate and well-controlled studies in adults and a 12-week double-blind, randomized, parallel-group trial in pediatric patients 7-17 years of age who met modified Rome III criteria for child/adolescent IBS-C.

ANTHEM-UC: Icotrokinra (JNJ-2113) Shows Promise for Ulcerative Colitis

On March 10, 2025, Johnson & Johnson announced positive topline results from the phase 2b ANTHEM-UC study of icotrokinra (JNJ-2113) in adults with moderately to severely active UC showing the study met its primary endpoint of clinical response in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at week 12.

Obefazimod Meets Primary Endpoint in Phase 3 ABTECT Program for Ulcerative Colitis

On July 23, 2025, Abivax SA announced positive topline results from its phase 3 ABTECT-1 (Study 105) and ABTECT-2 (Study 106) 8-week induction trials evaluating obefazimod (ABX464) in adult patients with moderately to severely active UC. Results from both trials showed obefazimod met its FDA primary endpoint of clinical remission at week 8 in the 50 mg once-daily dose regimens.

LUCENT-3: Mirikizumab (Omvoh) Shows Sustained Benefit in Ulcerative Colitis Through 4 Years

On October 7, 2025, Eli Lilly and Company announced data from the phase 3 LUCENT-3 open-label extension study establishing mirikizumab-mrkz (Omvoh) as the first and only interleukin-23p19 (IL-23p19) to help patients with moderately to severely active UC achieve sustained, long-term outcomes through 4 years. Results were seen across multiple symptomatic, clinical, endoscopic, histologic and quality-of-life measures, including among patients who had previously failed a biologic or advanced therapy (27%).

AGA Releases Gastroparesis Clinical Practice Guideline, Highlights Unmet Needs

On September 19, 2025, the AGA released its clinical practice guideline on the management of gastroparesis, offering 12 conditional recommendations for the diagnosis and management of the complex gastric motility disorder. The document provides recommendations for ensuring an accurate diagnosis and identifying evidence-based, effective treatments among the available pharmacologic and procedural interventions for patients with idiopathic gastroparesis or gastroparesis related to diabetes.

AGA Releases Updated Clinical Crohn’s Disease Guideline Reflecting New Therapies

On November 20, 2025, the AGA released a living clinical practice guideline on the pharmacologic management of moderate-to-severely active CD, intended to support a comprehensive, patient-centered, evidence-based approach to managing this patient population. The document includes 16 recommendations emphasizing early use of high-efficacy therapies including infliximab, adalimumab, ustekinumab, risankizumab, mirikizumab, guselkumab, and upadacitinib over step-up treatment to improve patient outcomes.

USMSTF Guidance on Optimizing Bowel Preparation for Colonoscopy

The USMSTF, which represents the American College of Gastroenterology, the American Gastroenterological Association, and the American Society for Gastrointestinal Endoscopy, released new guidance providing clinical recommendations to address challenges related to bowel preparation for colonoscopy, focusing specifically on outpatients at low risk for inadequate bowel preparation.

In a 6-part HCPLive RX Review, Brian Jacobson, MD, MPH, and Joseph Anderson, MD, discuss their work as co-authors on the recent USMSTF consensus statements and explain why adequate bowel preparation is so important in the context of colonoscopy.

Colonoscopy’s Role in CRC Screening, The Importance of Adequate Bowel Preparation

Bridging Gut and Skin Care: A Call for Collaboration in Inflammatory Disease Management

In this 3-part HCPLive Special Report, advisory board members Adelina Hung, MD, and Raj Chovatiya, MD, PhD, discuss the connection between immune-mediated inflammatory diseases in GI and dermatology, unmet needs in management, and what the future may hold for patient care and drug development.

The year 2025 marked significant advancements in gastroenterology, characterized by therapeutic innovations, updated clinical guidelines, and a focus on long-term disease management. Inflammatory bowel disease (IBD) saw notable FDA approvals, including new treatments for Crohn's disease and ulcerative colitis, emphasizing high-efficacy therapies. Progress extended to broader gastroenterology care with approvals for pediatric IBS-C and new guidelines for gastroparesis and colorectal cancer prevention. These developments underscore a year of consolidation and forward momentum, enhancing evidence-based practice and setting the stage for future innovations in gastrointestinal care.

The gastroenterology year in review covers FDA approvals, IBD breakthroughs, IL-23 therapies, new guidelines, and advances in GI care.

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.

Inflammatory Bowel Disease

On the HCPLive inflammatory bowel disease page, resources on the topics of medical news and expert insight into IBD can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBD and more.

Irritable Bowel Syndrome

On the HCPLive irritable bowel syndrome page, resources on the topics of medical news and expert insight into IBS can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBS, IBD, and more.

Ulcerative Colitis

Ulcerative Colitis condition center page, resources on the topics of medical news and expert insight into colitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on UC research, treatment, and drug development.

Gastroenterology in 2025: Year in Review

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

 has seen a series of dramatic shifts during the past year. Between the groundbreaking joint statement from the Heart Failure Society of America (HFSA) and the American Society for Preventive Cardiology (ASPC) calling for a shift towards preventive care in HF to the 

's approval of bumetanide nasal spray and finerenone, a substantial amount of progress has been made in improving the efficacy and availability of HF care.

Given the sheer volume of critical news released during 2025, the editorial team at 

 has collected 12 of the most impactful headlines from the past 12 months. Catch up on any major news you might have missed below.


FDA Updates Mavacamten Label in Obstructive Hypertrophic Cardiomyopathy

On April 17, 2025, the FDA updated mavacamten’s prescribing information for treating adults with New York Heart Association (NYHA) Class II-III 

obstructive hypertrophic cardiomyopathy (oHCM)

, aiming to simplify echo monitoring requirements for eligible patients in the maintenance phase. This decision reduced the frequency of required echo monitoring from once every 12 weeks to once every 6 months for patients with left ventricular ejection fraction (LVEF) ≥55% and a Valsalva LVOT gradient ≤30 mmHg who reached the maintenance phase at 12 weeks or later. The decision also expanded patient eligibility by reducing contraindications, such as those with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors.


FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More

On July 14, 2025, the FDA approved finerenone for reducing the risk of cardiovascular death, hospitalization for HF, and urgent HF visits in adults with HF with mildly reduced ejection fraction (HFmrEF) and preserved ejection fraction (HFpEF). This approval was based on results from the FINEARTS-HF trial, which saw finerenone substantially reduce the incidence of the above endpoints by 16% compared to placebo.

FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy


On December 19, 2025, the FDA announced its approval of aficamten tablets in 5 mg, 10 mg, 15 mg, and 20 mg doses to treat oHCM, aiming to improve functional capacity and symptoms. The allosteric and reversible inhibitor of cardiac myosin motor activity proved its safety and efficacy in the phase 3 SEQUOIA-HCM trial, which compared its impact on exercise capacity versus placebo. 

FDA Approves Bumetanide Nasal Spray for Edema with Congestive Heart Failure

On September 15, 2025, Corstasis Therapeutics announced the FDA’s approval of bumetanide nasal spray to treat edema associated with congestive heart failure (CHF), liver disease, and chronic kidney disease (CKD). This intranasal loop diuretic is designed to circumvent the absorption presented by overreliance on intravenous loop diuretics. During the RSQ-777-02 trial, the nasal spray proved its equivalence to oral bumetanide, as well as displaying a higher time to maximum concentration compared to oral administration.


HFSA and ASPC Release Statement on Shifting to Prevention in Heart Failure


On August 13, 2025, the HFSA and ASPC released a joint statement addressing the need for the prioritization of prevention and risk identification in HF care. The document calls for clinicians to take a more active role in identifying risk factors in patients, noting major drivers of the pathophysiologic cascade, such as inflammation. Additionally, the publication names a series of preventive factors for lifelong HF control, such as improved sleep, regular exercise, weight management, and control of blood pressure, cholesterol, and glycemia. Ultimately, the document breaks down 4 primary components of HF prevention: early risk identification, holistic care, proven therapies, and system-wide change.


Finerenone Limits Outpatient Oral Diuretic Intensification in Heart Failure


A secondary analysis of the FINEARTS-HF trial proved in February of 2025 that finerenone has the capacity to prevent outpatient worsening HF events requiring oral diuretic intensification in patients with mildly reduced or preserved ejection fraction. In addition to further indicating the benefit of finerenone in decreasing worsening HF events, the trial was also cited as a major argument in favor of adopting outpatient oral diuretic intensification as an indicator of worsening HF.


DAPA-EAT: Dapaglifozin Reduces Epicardial Adipose Tissue in Patients with Asymptomatic HF

DAPA-EAT was presented at the American Heart Association’s Scientific Sessions in New Orleans, Louisiana, highlighting dapagliflozin’s substantial efficacy in reducing epicardial adipose tissue (EAT), left ventricular myocardial fibrosis and volume, and improved diastolic filling dynamics in patients with asymptomatic HF. During the trial, dapagliflozin reduced EAT by 15.6 mL compared to the control cohort’s 9.6 mL reduction. However, most echocardiographic parameters showed no significant differences, with no changes observed in the biomarkers of the E/A ratio.


SURPASS-CVOT: Tirzepatide Bests Dulaglutide for Cardiovascular Protection


On July 31, 2025, Eli Lilly and Company announced positive topline results from the head-to-head phase 3 SURPASS-CVOT trial, which compared tirzepatide and dulaglutide in adults with 

. During the trial, tirzepatide demonstrated a non-inferior rate of major adverse cardiovascular events, including cardiovascular death, heart attack, and stroke, compared to dulaglutide. Additionally, although the trial was not controlled for multiplicity-adjusted type-1 error, tirzepatide also resulted in improvements on measures of A1C, weight, renal function, and all-cause mortality.


HFSA/ASPC Heart Failure Prevention: From Prognosis to Prevention in Heart Failure


Following the joint statement from the ASPC and HFSA, 

 hosted a 7-part special report to break down the new framework and its establishment of HF as a preventable condition. In this first episode, moderator James Januzzi, MD, is joined by Martha Gulati, MD, MS, and Anu Lala, MD, to highlight the need to bridge the gap between HF care and preventive cardiology. Despite remaining largely preventable, HF is a rapidly growing epidemic with high costs to both clinicians and patients. Preventive cardiology and HF care have traditionally been separate, but Gulati and Lala emphasize the importance of unifying the 2 fields via the new statement.


Don't Miss a Beat: Vericiguat in Heart Failure and the VICTOR Trial, With Javed Butler, MD


Although the VICTOR trial, which investigated vericiguat in patients with ambulatory HFrEF who had received contemporary background therapy, failed to achieve its primary endpoint, it did display fewer cardiovascular and all-cause deaths. Given this, investigators have suggested vericiguat may prove beneficial in ambulatory HFrEF when combined with optimal background therapy. To further discuss this, cohosts Stephen Greene, MD, and Muthiah Vaduganathan, MD, MPH, spoke with Javed Butler, MD, to discuss vericiguat’s potential as a mortality-reducing therapy in HFrEF and its possible place in an emerging “quintuple therapy” standard.


Don't Miss a Beat: Debating Oral Diuretic Intensification as an Endpoint in Heart Failure Trials


This episode centered around the ongoing debate for establishing oral diuretic intensification, particularly in light of its frequency and prognostic value, as an endpoint for future HF trials. Additionally, in comparison to historical endpoints, including all-cause mortality and HF hospitalization, oral diuretic intensification may potentially increase event capture in future clinical trials. However, definitions of oral diuretic intensification vary across studies, ranging from dose doubling to drug class switching and short-term use of additional diuretics. Still, the prognostic importance of this measurement makes it worth considering, even with the required overhauls to both definition and trial frameworks prior to its implementation.


Don't Miss a Beat: POLY-HF & the Potential of Polypills in HF, With Ambarish Pandey, MD

In this episode, recorded onsite at the 2025 American Heart Association Scientific Sessions in New Orleans, saw Greene and Vaduganathan meet with Ambarish Pandey, MD, from UT Southwestern, to discuss the POLY-HF trial – specifically, the novel concept of a polypill approach to HFrEF. The trial tested a singular pill including 3 GDMT classes – metoprolol succinate, spironolactone, and empagliflozin – in the enhancement of treating adherence and cardiac function compared to usual care. Patients receiving the polypill demonstrated a 3.4% greater improvement in LVEF, as well as a 50% reduction in recurrent HF hospitalizations.

Heart failure management has evolved significantly, with a focus on preventive care and new FDA approvals. Key developments include the FDA's approval of finerenone for heart failure with mildly reduced or preserved ejection fraction, and bumetanide nasal spray for edema in congestive heart failure. The HFSA and ASPC emphasize prevention, highlighting risk identification and lifestyle factors. Trials like FINEARTS-HF and DAPA-EAT demonstrate the efficacy of finerenone and dapagliflozin, respectively. The SURPASS-CVOT trial shows tirzepatide's cardiovascular benefits. Discussions on vericiguat and polypills highlight potential advancements in heart failure treatment.

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

Cardiology

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

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.

FDA News

Heart Failure in 2025: Year in Review

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

2025 marked a year of meaningful expansion and maturation in psoriatic arthritis (PsA) care, as advances in immunology translated into broader treatment options, earlier intervention strategies, and clearer regulatory momentum. The field continued to move beyond symptom control alone, with growing emphasis on disease modification, functional outcomes, and addressing long-standing gaps in diagnosis and access—particularly for younger patients and those with prior treatment failure.

Regulatory developments underscored this progress, highlighted by the FDA approval of guselkumab for pediatric plaque psoriasis and PsA, extending IL-23 inhibition into younger populations for the first time. At the same time, oral targeted therapies gained traction, with deucravacitinib advancing toward FDA review following strong phase 3 data demonstrating improvements across joint, skin, and radiographic outcomes. Together, these milestones signaled a broadening PsA armamentarium that spans age groups, mechanisms of action, and routes of administration.

Clinically, 2025 delivered a wave of pivotal and late-stage data reinforcing both established and emerging pathways. IL-23 inhibition continued to solidify its role with positive phase 3 tildrakizumab trials, while TYK2 inhibition emerged as a major theme through encouraging results from deucravacitinib and zasocitinib. Head-to-head evidence favoring secukinumab in post-TNFi disease and early promise from next-generation agents like the IL-17A/IL-17F nanobody sonelokimab further defined treatment sequencing. These advances, combined with expert discussions emphasizing the urgency of coordinated dermatology–rheumatology care, framed 2025 as a year that not only advanced PsA therapeutics, but also sharpened the clinical strategy around using them.

FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis

On September 29, 2025, the FDA approved guselkumab (Tremfya) for children aged ≥6 years and weighing ≥40 kg with moderate to severe plaque psoriasis or active psoriatic arthritis, making it the first IL-23 inhibitor approved for these pediatric indications. The decision was supported by the phase 3 PROTOSTAR trial, where guselkumab significantly improved skin clearance compared with placebo, and by extrapolated data from adult PsO and PsA studies. This expands guselkumab’s use beyond its prior adult approvals and provides a new treatment option for children with these immune-mediated diseases.

TYK2 Inhibitor Deucravacitinib up for FDA Review for Psoriatic Arthritis

The FDA accepted Bristol Myers Squibb’s sNDA for deucravacitinib in active psoriatic arthritis with a PDUFA date of March 6, 2026, based on phase 3 POETYK PsA trials showing 54.2% of patients achieved ACR20 at week 16 versus 34.1% with placebo (

 <.0001). The TYK2 inhibitor also significantly improved PASI 75 response, physical function, fatigue, and radiographic progression, with no new safety signals and a low rate of serious adverse events.

Pivotal Tildrakizumab Trials Meet Endpoint for Psoriatic Arthritis

Tildrakizumab 100 mg met its primary endpoint in both INSPIRE-1 and INSPIRE-2 phase 3 trials by significantly improving ACR20 response rates at week 24 versus placebo (

 <.05) in patients with active psoriatic arthritis. The IL-23 inhibitor also showed improvements in ACR50, ACR70, and PASI75 with a safety profile consistent with previous psoriasis trials, reinforcing its potential as a PsA treatment option.

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.

Zasocitinib Data Demonstrates Efficacy of TYK2 Inhibition for Psoriatic Arthritis

In a phase 2b trial, zasocitinib 30 mg and 15 mg significantly improved ACR20 responses at week 12 in patients with active psoriatic arthritis (54.2% and 53.3%, respectively, vs. 29.2% with placebo; 

 = .002), with additional numeric gains seen in ACR50, ACR70, PASI 75, and MDA rates. The drug’s safety profile remained manageable with no new safety signals, supporting TYK2 inhibition as a promising, targeted, and potentially safer oral treatment pathway for PsA; phase 3 trials are currently underway.

AgAIN: Secukinumab Outperforms Ustekinumab in Post-TNFi Psoriatic Arthritis, With Frank Behrens, MD

Secukinumab demonstrated superior efficacy to ustekinumab in TNFi-experienced patients with psoriatic arthritis in the phase 3b AgAIN trial. At week 28, 57.1% of patients receiving secukinumab achieved HAQ-DI response versus 27.0% with ustekinumab (

 = .002), with greater improvements across joint, skin, and pain outcomes, and fewer discontinuations due to loss of efficacy.

Sonelokimab Demonstrates Psoriatic Arthritis Improvements Over Placebo

Sonelokimab met its primary endpoint in a phase 2 trial, significantly improving psoriatic arthritis signs and symptoms with higher ACR50 response rates at week 12 versus placebo. As a dual IL-17A/IL-17F–targeting nanobody, the therapy demonstrated robust joint and skin efficacy with a favorable safety profile, supporting its continued evaluation in ongoing phase 3 PsA studies.

Closing the Gap: Collaborating Care to Improve Outcomes in Psoriasis and Psoriatic Arthritis

Experts are calling for earlier, more coordinated detection of psoriatic arthritis, which develops in up to 30% of patients with psoriasis and is often diagnosed years too late. In this 

 feature, leading dermatology and rheumatology voices discuss how routine screening, shared treatment strategies, and cross-specialty collaboration can help close diagnostic gaps and prevent irreversible joint damage.

1. Brooks A. FDA Approves Guselkumab (Tremfya) for Pediatric Plaque Psoriasis, Psoriatic Arthritis. Article. HCPLive. September 29, 2025. https://www.hcplive.com/view/fda-approves-guselkumab-tremfya-for-pediatric-plaque-psoriasis-psoriatic-arthritis

2. Johnson V. TYK2 Inhibitor Deucravacitinib up for FDA Review for Psoriatic Arthritis. Article. HCPLive. July 21, 2025. https://www.hcplive.com/view/tyk2-inhibitor-deucravacitinib-up-for-fda-review-for-psoriatic-arthritis

3. Johnson V. Pivotal Tildrakizumab Trials Meet Endpoint for Psoriatic Arthritis. Article. HCPLive. July 25, 2025. https://www.hcplive.com/view/pivotal-tildrakizumab-trials-meet-endpoint-for-psoriatic-arthritis

4. Johnson V. Phase 3 Deucravacitinib Trial Meets ACR20 End Point in PsA. Article. HCPLive. June 11, 2025. https://www.hcplive.com/view/phase-3-deucravacitinib-trial-meets-acr20-end-point-in-psa

5. Johnson V. Zasocitinib Data Demonstrates Efficacy of TYK2 Inhibition for Psoriatic Arthritis. Article. HCPLive. July 16, 2025. https://www.hcplive.com/view/zasocitinib-data-demonstrates-efficacy-of-tyk2-inhibition-for-psoriatic-arthritis

6. Behrens F. AgAIN: Secukinumab Outperforms Ustekinumab in Post-TNFi Psoriatic Arthritis, With Frank Behrens, MD. Video. HCPLive. October 28, 2025. https://www.hcplive.com/view/again-secukinumab-outperforms-ustekinumab-post-tnfi-psoriatic-arthritis-behrens

7. Johnson V. Sonelokimab Demonstrates Psoriatic Arthritis Improvements Over Placebo. Article. HCPLive. October 10, 2025. https://www.hcplive.com/view/sonelokimab-demonstrates-psoriatic-arthritis-improvements-over-placebo

8. Johnson V, Smith T. Closing the Gap: Collaborating Care to Improve Outcomes in Psoriasis and Psoriatic Arthritis. Article. HCPLive. August 25, 2025. https://www.hcplive.com/view/closing-gap-collaborating-care-improve-outcomes-psoriasis-psa

In 2025, psoriatic arthritis (PsA) care saw significant advancements, with new treatment options and strategies emerging from immunological research. Regulatory progress included the FDA's approval of guselkumab for pediatric use and the advancement of oral therapies like deucravacitinib. Clinical trials reinforced the efficacy of IL-23 and TYK2 inhibitors, with promising results from tildrakizumab, deucravacitinib, and zasocitinib. Secukinumab showed superiority in post-TNFi PsA, while sonelokimab demonstrated potential in early trials. Experts emphasized the importance of coordinated dermatology-rheumatology care to improve diagnosis and treatment outcomes.

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

Psoriatic Arthritis

On the HCPLive psoriatic arthritis page, resources on the topics of medical news and expert insight into PsA can be found. Content includes articles, interviews, videos, podcasts, and breaking news on arthritis, and more.

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Psoriatic Arthritis in 2025: Year in Review

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.

 underwent rapid and consequential changes, signaling newfound opportunity and choice for clinicians in the once-limited treatment landscape.

These developments were marked by multiple 

approvals, pivotal phase 3 readouts, and an updated 2025 Kidney Disease: Improving Global Outcomes (KDIGO) IgAN guideline. The FDA granted accelerated approval to sibeprenlimab (Voyxact) based on proteinuria reduction in the phase 3 VISIONARY trial, approved atrasentan (Vanrafia) as the first selective endothelin A receptor antagonist for IgAN, and updated the Risk Evaluation and Mitigation Strategy (REMS) requirements for sparsentan (Filspari), reducing liver monitoring frequency and removing embryo-fetal toxicity monitoring.

At the same time, late-stage clinical trials, including APPLAUSE-IgAN evaluating iptacopan (Fabhalta), phase 3 studies of telitacicept, and emerging data for povetacicept and mezagitamab, provided growing evidence of targeted complement inhibition and B-cell modulation slowing disease progression and reducing proteinuria.

These developments, alongside the release of the international clinical guidance, collectively signal a shift toward earlier, mechanism-driven intervention. 

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy

On August 27, 2025, Travere Therapeutics announced FDA approval of an updated REMS labeling for sparsentan (Filspari) in IgAN. The update reduces liver function monitoring from monthly to every 3 months and removes embryo-fetal toxicity monitoring, based on safety data from post-marketing surveillance and the phase 3 PROTECT, phase 3 DUPLEX, and phase 2 DUET trials. Less intensive monitoring may improve patient adherence and broaden the practical use of sparsentan in IgAN management.

FDA Awards Accelerated Approval to Sibeprenlimab in IgA Nephropathy

On November 25, 2025, the FDA approved sibeprenlimab (Voyxact), a targeted APRIL inhibitor from Otsuka Pharmaceutical, for reducing proteinuria in adults with primary IgAN at risk for disease progression. Approval was based on results from the VISIONARY trial, the largest phase 3 IgAN study to date, which demonstrated a 54.3% placebo-adjusted reduction in 24-hour urine protein-to-creatinine ratio (UPCR) after 12 months. Sibeprenlimab provides a first-in-class option targeting APRIL, signaling the emergence of mechanism-based therapies beyond conventional supportive care.

Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy

On April 2, 2025, the FDA approved atrasentan, a once-daily, non-steroidal oral endothelin A receptor antagonist, for reducing proteinuria in adults at risk of rapid progression. The approval confirms proteinuria as a regulatory-accepted surrogate endpoint and expands nephrology’s antiproteinuric toolkit.

Progress in IgAN and Future Innovations in Nephrology, with Richard Lafayette, MD

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

Finerenone treatment in patients with IgAN on standard supportive care reduced protein-to-creatinine ratio and maintained stable estimated glomerular filtration rate (eGFR) over 6 months, with a 25% relative reduction in urine albumin-to-creatinine ratio (UACR) versus placebo.

These results suggest finerenone may provide kidney protection and reduce cardiovascular risk, expanding its potential role in managing patients with proteinuric kidney disease.

Povetacicept Data Validate APRIL/BAFF Inhibition in IgAN and pMN, With James Tumlin, MD

In the phase 1/2 RUBY-3 trial, povetacicept led to sustained reductions in UPCR, galactose-deficient IgA1 (Gd-IgA1), and hematuria, while maintaining stable eGFR in patients with IgAN and primary membranous nephropathy (pMN). James Tumlin, MD, highlighted that these upstream immunologic effects translate into meaningful proteinuria reductions. Povetacicept reinforces the potential of B-cell–modulating therapies to achieve disease-modifying outcomes in IgAN.

APPLAUSE-IgAN: Iptacopan (Fabhalta) Meets eGFR Decline Primary Endpoint

The phase 3 APPLAUSE-IgAN trial demonstrated that iptacopan, an oral alternative complement pathway inhibitor, significantly slowed IgAN progression, measured by the annualized total slope of eGFR decline over 2 years. Novartis plans to use these data for regulatory submissions in 2026. Iptacopan offers a potential oral complement-targeted therapy that could reduce the burden of progressive kidney loss in IgAN.

Mezagitamab Shows Promise for IgA Nephropathy in Phase 1b Trial, with Jonathan Barratt, MD, PhD

Interim data from a phase 1b trial led by Jonathan Barratt, MD, PhD, suggest mezagitamab, a CD38-targeting monoclonal antibody, achieved meaningful biological and clinical responses with no Grade 3 or higher infections when added to standard care. Early results indicate CD38-targeted therapy may provide a novel immunomodulatory approach for IgAN management.

Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study

RemeGen’s telitacicept, a fusion protein targeting B-lymphocyte stimulator (BLyS) and APRIL, demonstrated efficacy and a favorable safety profile over 39 weeks, reducing UPCR and affecting immunoglobulin levels in high-risk IgAN patients. Telitacicept strengthens the pipeline of B-cell–modulating therapies with the potential to alter disease course in IgAN.

KDIGO Releases Updated IgA Nephropathy, IgA Vasculitis Clinical Practice Guideline

The 2025 KDIGO Clinical Practice Guideline, co-chaired by Jürgen Floege, MD, and Brad Rovin, MD, emphasizes early initiation of therapies targeting both IgA-containing immune complex formation and downstream nephron injury. Guidelines reinforce a precision-based approach, encouraging use of targeted therapies in early disease to prevent irreversible kidney damage.

In 2025, the treatment landscape for IgA nephropathy (IgAN) experienced significant advancements, marked by multiple FDA approvals and pivotal clinical trial results. The FDA approved sibeprenlimab, atrasentan, and updated REMS for sparsentan, enhancing therapeutic options. Late-stage trials for iptacopan, telitacicept, and others showed promising results in reducing proteinuria and slowing disease progression. The updated KDIGO guidelines emphasized early, mechanism-driven interventions. These developments highlight a shift towards precision-based therapies, offering clinicians a broader array of targeted treatments to manage IgAN effectively.

IgA nephropathy advanced in 2025 with FDA approvals, positive phase 3 trials, and growing disease-modifying therapies


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