Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

 has spotlighted many major developments in 

 in our coverage, spanning high-impact clinical trial readouts, regulatory decisions by the 

, and evolving standards of care for chronic skin conditions. Notable news headlines included updated safety and efficacy findings on oral small molecules such as Janus Kinase (JAK) inhibitors, continued expansion of biologic and targeted drugs into new dermatologic indications, and growing attention to the role of artificial intelligence (AI) and digital tools in the field.

Alongside these regulatory and research milestones, 

 podcasts throughout the year showcased expert perspectives across dermatology, with discussions highlighting various advances in diagnostic innovation, personalized treatment strategies, and even work-life balance for clinicians. In this Year in Review overview, the editorial team has curated some of the most consequential dermatology-related headlines and expert commentary published on the 

 platform, allowing for greater perspective as 2026 approaches.

Delgocitinib (Anzupgo) Scores FDA Approval for Chronic Hand Eczema

The approval of delgocitinib (Anzupgo) cream was announced in 2025 for the treatment of moderate-to-severe chronic hand eczema (CHE). The announcement by LEO Pharma highlighted delgocitinib cream’s use for CHE among adult patients who have had an inadequate response to, or for whom topical corticosteroids are not advisable. The medication’s FDA approval was based on data from the DELTA 1 and DELTA 2 clinical studies.

FDA Approves Pz-cel (Zevaskyn) Gene Therapy for RDEB

The FDA also approved prademagene zamikeracel (Zevaskyn) in 2025 for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Abeona Therapeutics Inc.’s 2025 announcement of the approval noted prademagene zamikeracel, often referred to as pz-cel, is the first autologous cell-based gene therapy for the treatment of wounds in adult and pediatric patients with RDEB, marking a significant milestone for the debilitating condition.

FDA Approves Adalimumab-aaty (Yuflyma) Pediatric Indications in Hidradenitis Suppurativa, Uveitis

The FDA’s approval of adalimumab-aaty (Yuflyma) was announced by Celltrion in 2025, with adalimumab-aaty’s indication expanded, along with its unbranded version, to include adolescent patients ≥ 12 years of age living with hidradenitis suppurativa (HS) and treating uveitis (UV) in patients ≥ 2 years of age. The recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody was designated by the agency as an interchangeable biosimilar in a prefilled syringe and autoinjector.

FDA Approves Remibrutinib for Chronic Spontaneous Urticaria

Remibrutinib (Rhapsido), a highly selective Bruton’s tyrosine kinase (BTK) inhibitor, was approved in 2025 for adults with chronic spontaneous urticaria (CSU). The medication was specifically approved for those with CSU who are unresponsive to antihistamines, providing an oral alternative to omalizumab. Phase 3 research on remibrutinib has shown significant reductions in CSU symptoms, with sustained efficacy beibg observed for up to 52 weeks.

ICONIC-ADVANCE: Icotrokinra Beats Deucravacitinib for Plaque Psoriasis

Johnson & Johnson noted, in September 2025 icotrokinra was shown in new data to be superior to deucravacitinib (Sotyktu) for achievement of skin clearance among those with moderate-to-severe plaque psoriasis at the 16 and 24-week marks. The first-in-class investigational targeted oral IL-23 inhibitor also demonstrated comparable rates of adverse events (AEs) to placebo in 52-week data from the ICONIC-LEAD trial. Both ICONIC-ADVANCE and ICONIC-LEAD’s findings were released at the European Association of Dermatology and Venereology (EADV) 2025 Congress in Paris, France.

Nemolizumab Rapidly Relieves Itch in Atopic Dermatitis, Prurigo Nodularis

A post-hoc analysis in 2025 of the ARCADIA and OLYMPIA trials confirmed significant improvements in itch and sleep outcomes by the second day of treatment with nemolizumab. The drug relieved itch and sleep disturbances by the second day of utilization among patients living with moderate-to-severe atopic dermatitis and those with prurigo nodularis. These data pointed to the potential of targeting the IL-31 pathway for these 2 dermatologic disease states.

Temtokibart Shows Benefit, Effect on Biomarkers in Phase 2b Atopic Dermatitis Trial

A set of presentations on phase 2b findings was released during the European Association of Dermatology and Venereology (EADV) 2025 Congress, highlighting temtokibart’s impact in adults with moderate-to-severe atopic dermatitis. These late-breaking data suggest temtokibart, an investigational monoclonal antibody designed to target the IL-22RA1 receptor subunit from Leo Pharma, was linked with significant improvements in several measures of atopic dermatitis severity and activity.

Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

Takeda highlighted positive topline findings from a set of phase 3 multicenter, randomized, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279) in 2025. The drug, a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, was formulted to treat adults with moderate-to-severe psoriasis. In the Latitude studies, the superiority of zasocitinib compared to placebo for the co-primary endpoints of static Physician Global Assessment (sPGA) 0/1 and Psoriasis Area and Severity Index (PASI) 75 was observed at the 16-week mark.

AI in Dermatology: Discussing Downsides to the Adoption of Artificial Intelligence

In a ‘This Year in Medicine’ series feature article from 2025, titled ‘AI in Dermatology: Discussing Downsides to the Adoption of Artificial Intelligence,' the evolving topic of AI, its practical use in fields such as medicine, and the potential downsides of its widespread utilization were covered. Despite the view among many in the field suggesting AI is beneficial for addressing the needs of patients with diseases such as psoriasis, this feature highlighted 3 experts’ varied opinions on AI and recent data highlighting possible issues with reliance on such technologies.

Rethinking the Black Box: JAK Inhibitors Find Their Place in Dermatology

In a feature posted in October 2025, interviews with a series of experts in dermatology were conducted to examine different perceptions in JAK inhibitor safety, to explore the initial excitement surrounding such drugs, the subsequent caution resulting from black box warnings, and the more recent confidence seen in the months since. JAK inhibitors and their safety were viewed as important to examine in this feature, as they have seen an explosion in approvals and are fast becoming key players in the management of conditions such as psoriasis, alopecia areata, and atopic dermatitis.

The Connection Between Gut Health and Dermatologic Diseases

 Special Report series, Raj Chovatiya, MD, PhD, clinical associate professor at Rosalind Franklin University Chicago Medical School and the director of the Center for Medical Dermatology and Immunology Research, spoke alongside his wife, Adalina Hung, MD, a board-certified gastroenterologist and hepatologist. Hung is known for her role as director of the IBD Program at Sinai Health System, Chicago, and as a clinical assistant professor at the Rosalind Franklin University Medical School. The pair highlighted the overlapping immunologic and barrier-based mechanisms shared between dermatologic and gastrointestinal diseases.

Articles

In 2025, significant advancements in dermatology were marked by FDA approvals, clinical trial updates, and expert insights. Key FDA approvals included delgocitinib for chronic hand eczema, prademagene zamikeracel for RDEB, and remibrutinib for chronic spontaneous urticaria. Clinical trials revealed promising results for icotrokinra in plaque psoriasis and nemolizumab in atopic dermatitis. The role of AI in dermatology was critically examined, alongside discussions on JAK inhibitors and the interplay between gut health and dermatologic diseases, providing a comprehensive overview of the year's dermatological progress.

Catch up on news headlines highlighted in the dermatology space by HCPLive in 2025 with this Year in Review.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

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.

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.

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.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Dermatology in 2025: Year in Review

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.

The past year saw significant progress in 

 approvals expanding treatment options for hereditary angioedema (HAE), including donidalorsen, sebetralstat, and garadacimab-gxii. Clinicians now have access to therapies that improve attack prevention, offer oral and less frequent dosing options, and provide new tools for pediatric patients, addressing long-standing gaps in care.

Beyond HAE, advances in food allergy management, chronic rhinosinusitis, and anaphylaxis treatment highlighted the evolving landscape. Early peanut introduction continues to reduce allergy prevalence, intranasal epinephrine offers a needle-free emergency option, and dupilumab shows promise in difficult-to-treat allergic fungal rhinosinusitis. Together, these developments are reshaping clinical practice and patient management across age groups.

FDA Approves Donidalorsen to Prevent Hereditary Angioedema Attacks

The FDA approved the RNA-targeted donidalorsen (DAWNZERA) to prevent HAE attacks in patients aged ≥ 12 years, announced by Ionis Pharmaceuticals on August 21, 2025. Backed by OASIS-HAE, OASISplus, and phase 2 OLE trials, the therapy cut monthly attacks up to 81%, with sustained safety.

FDA’s Approval of Donidalorsen for HAE, With William Lumry, MD

Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema

Announced on July 7, 2025, the FDA approved KalVista Pharmaceuticals’ sebetralstat (Ekterly), the first oral, on-demand therapy for acute HAE in patients aged ≥ 12 years. Supported by phase 3 KONFIDENT trials, experts say it enables earlier, guideline-aligned treatment.

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

CSL announced on June 16, 2025, that the FDA approved garadacimab-gxii (ANDEMBRY), the first factor XIIa–targeting therapy to prevent HAE attacks in patients aged ≥ 12 years. CSL’s once-monthly monoclonal antibody reduced HAE attacks by ≥ 99% versus placebo in the phase 3 VANGUARD trial, offering a convenient, citrate-free prophylactic option.

FDA Approves First Interchangeable Biosimilar for Omalizumab

Announced on March 9, 2025, the FDA approved omalizumab-igec (OMLYCLO), the first interchangeable biosimilar to Xolair, for asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy, and chronic spontaneous urticaria. Phase 3 trials confirmed bioequivalence, safety, and efficacy. Celltrion USA highlights OMLYCLO’s potential to expand patient access, reduce healthcare costs, and offer convenient prefilled syringe dosing.

FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE

Biocryst on December 12, 2025, announced that the FDA approved berotralstat (ORLADEYO) oral granules for children aged 2–11 years with HAE, providing the first pediatric oral prophylactic option. Based on APeX-P trial data, berotralstat safely reduced monthly attacks, offering a less burdensome alternative to infusions or injections and addressing a critical treatment gap in young patients with HAE.

Cephalexin Recommended for Dermatologic Surgery with Penicillin Allergy

The American Society for Dermatologic Surgery recommends cephalexin as the first-line prophylactic antibiotic for patients with penicillin allergy undergoing dermatologic surgery. With low cross-reactivity, especially among first-generation cephalosporins, cephalexin offers superior safety and efficacy. True penicillin allergy is uncommon, and most patients lose sensitivity over time.

New Guidelines Outline When to Consider Sinus Surgery for Chronic Rhinosinusitis

The American Academy of Otolaryngology–Head and Neck Surgery released updated guidelines for chronic rhinosinusitis, offering 11 evidence-based recommendations. Surgery is advised when benefits outweigh medical therapy, particularly for patients with polyps, fungal infections, frequent exacerbations, or worsening asthma, emphasizing diagnosis confirmation and avoiding unnecessary antibiotics.

Over 70% of Toddlers Tolerate 3 to 4 Peanut Kernels 3 Years After Peanut Patch

New data from the 2025 ACAAI meeting show the Viaskin Peanut Patch builds peanut tolerance in over 70% of toddlers after 3 years. Epicutaneous immunotherapy safely delivers peanut protein through the skin, increasing tolerated amounts and reducing severe reactions. This patch offers a promising long-term option for early peanut allergy management.

Dupilumab Shows Promise for Allergic Fungal Rhinosinusitis in Phase 3 Trial, With Amber Luong, MD, PhD

Phase 3 LIBERTY AIMS data show dupilumab (Dupixent) significantly improves outcomes in allergic fungal rhinosinusitis (AFRS), a challenging CRSwNP subtype. In 62 patients, dupilumab reduced sinus opacification, nasal polyp size, congestion, and the need for surgery or oral corticosteroids, offering a safe, steroid-sparing treatment option for difficult-to-treat AFRS.

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

Phase 3 RAPIDe-3 trial shows oral deucrictibant rapidly relieves HAE symptoms, with onset under 90 minutes and most attacks resolving with a single dose. The bradykinin B2 receptor antagonist demonstrated significant symptom improvement versus placebo and a favorable safety profile, supporting its potential as an on-demand HAE therapy.

Peanut Allergy Rates Plummet 10 Years After AAP Early Introduction Guidelines

A decade after AAP's early peanut introduction guidelines, peanut allergy rates dropped 27–43%, with overall IgE-mediated food allergies also declining. This report highlighted the real-world impact of early introduction while emphasizing ongoing challenges in guideline implementation.

One Year Later: How Intranasal Epinephrine Is Changing Emergency Allergy Treatment

One year after FDA approval, intranasal epinephrine (neffy) offers a needle-free, easy-to-use alternative for anaphylaxis, improving accessibility, clinician experience, and patient adherence, particularly for children and needle-averse individuals.

Microbes, Medicine, Modern Life May Drive Food Allergy Rise, Experts Say

Experts attribute rising food allergies to delayed allergen introduction, microbial imbalances, antibiotic use, C-sections, and environmental factors. Early exposure and microbiome-focused strategies may help curb this growing public health concern.

Rare Disease, Rapid Progress: FDA's HAE Approvals in 2025 Signal Changing Course

In 2025, the FDA approved 3 new HAE treatments—garadacimab-gxii, sebetralstat, and donidalorsen—expanding personalized care, improving attack prevention, and highlighting the ongoing need for pediatric-focused therapies.

Recent advancements in allergy and immunology have led to multiple FDA approvals, expanding treatment options for hereditary angioedema (HAE) with therapies like donidalorsen, sebetralstat, and garadacimab-gxii. These treatments offer improved attack prevention, oral and less frequent dosing, and pediatric options. Progress in food allergy management, chronic rhinosinusitis, and anaphylaxis treatment is reshaping clinical practice. Notable developments include early peanut introduction reducing allergy prevalence, intranasal epinephrine as a needle-free emergency option, and dupilumab's promise in treating allergic fungal rhinosinusitis.

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.

Food Allergy

Seasonal Allergy

Anaphylaxis

The HCPLive anaphylaxis page is a comprehensive resource for clinical news and insights on acute allergic reactions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for preventing anaphylaxis, and more.

​​Allergy 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.

, defined by regulatory milestones, therapeutic expansion, and growing clarity around how liver diseases may be diagnosed, treated, and studied moving forward. Across viral hepatitis, 

, and cholestatic liver diseases, the year reflected both long-awaited progress and ongoing recalibration as the field responded to new evidence, new approvals, and new uncertainties.

Regulatory momentum was especially visible in viral hepatitis and MASH. The FDA’s label expansion of glecaprevir/pibrentasvir for acute 

 marked a major advance in early intervention and cure, while the approval of semaglutide for noncirrhotic MASH reinforced the central role of metabolic therapies in liver disease management. At the same time, the FDA’s acceptance of FibroScan liver stiffness measurement as a reasonably likely surrogate endpoint signaled a potential inflection point for MASH drug development, complementing continued pipeline advances from agents such as pemvidutide and efruxifermin and reflecting a broader shift toward noninvasive assessment.

Despite these advances, 2025 was not defined by progress alone. The voluntary withdrawal of obeticholic acid for 

 underscored persistent safety and efficacy challenges in cholestatic disease, even as nebokitug moved closer to a registrational pathway for PSC. Policy decisions, including changes to CDC recommendations on infant hepatitis B vaccination, sparked debate and highlighted the evolving intersection of evidence, public health, and clinical practice. Together, these developments made 2025 a year of acceleration and reassessment, reshaping the hepatology landscape while setting the stage for the next era of innovation.

FDA Approves Glecaprevir/Pibrentasvir (Mavyret) Label Expansion for Acute HCV

On June 11, 2025, the FDA approved a label expansion for AbbVie’s glecaprevir/pibrentasvir (Mavyret), an oral pangenotypic direct acting antiviral (DAA) therapy. With this decision, glecaprevir/pibrentasvir is now approved for the treatment of adults and pediatric patients ≥ 3 years of age with acute or chronic HCV infection without cirrhosis or with compensated cirrhosis.

The approval was supported by data from the phase 3, multicenter, single-arm prospective M20-350 study evaluating the safety and efficacy of glecaprevir/pibrentasvir 8-week treatment in adults with acute HCV infection. Of note, the decision made glecaprevir/pibrentasvir the first and only DAA therapy approved to treat patients with acute HCV in 8 weeks with a 96% cure rate.

FDA Approves Semaglutide (Wegovy) Injection 2.4 mg for Noncirrhotic MASH

On August 15, 2025, the FDA approved Novo Nordisk’s semaglutide (Wegovy) injection 2.4 mg for the treatment of adults with MASH with moderate to advanced fibrosis, but not with cirrhosis, in conjunction with a reduced calorie diet and increased physical activity. The decision made semaglutide the second-ever FDA-approved MASH therapeutic and was based on results from the phase 3 ESSENCE trial investigating the effects of once-weekly semaglutide 2.4 mg injection on liver histology in adults with MASH and moderate to advanced liver fibrosis at week 72.

FDA Accepts FibroScan Letter of Intent for Surrogate Endpoint in MASH Trials

On September 8, 2025, the FDA’s Center for Drug Evaluation and Research, Office of New Drugs accepted Echosens’ Letter of Intent for the qualification of Liver Stiffness Measurement (LSM) by VCTE (FibroScan) as a reasonably likely surrogate endpoint in clinical trials for MASH. The decision marked the first time the FDA accepted the initiation of the qualification process of a noninvasive test as a reasonably likely surrogate endpoint in drug development for MASH. The Letter of Intent included official letters of support from Eli Lilly, Boehringer Ingelheim, and Novo Nordisk.

Intercept Voluntarily Withdraws Obeticholic Acid (Ocaliva) for PBC From US Market

On September 11, 2025, Intercept Pharmaceuticals announced its decision to voluntarily withdraw obeticholic acid (Ocaliva) from the US market for the treatment of PBC following a request from the FDA, The Agency additionally placed a clinical hold on all Intercept clinical trials conducted under a US IND involving obeticholic acid.

Nebokitug (CM-101) Gets FDA Runway for PSC Approval

On February 19, 2025, Chemomab Therapeutics announced the successful completion of an end-of-phase 2 meeting with the FDA as well as alignment with the agency on the design of a single phase 3 registration study for nebokitug (CM-101) for the treatment of PSC.

“Until now, the pathway to drug approval in PSC has been problematic due to the lack of validated surrogate endpoints and clarity around primary efficacy endpoints for PSC registration trials. This has been a major hindrance to the development of effective therapies for PSC,” Christopher Bowlus, MD, the Lena Valente Professor and Chief of the Division of Gastroenterology and Hepatology at the University of California Davis School of Medicine, commented. “The agreed composite endpoint approach for the nebokitug trial enhances our chances of efficiently and accurately identifying the potential clinical benefits of this promising new drug.

Pemvidutide Shows Continued Antifibrotic Activity for MASH, Progresses to Phase 3 Trial

Topline 48-week data from the phase 2b IMPACT trial of pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, in patients with MASH showed treatment with pemvidutide achieved statistically significant improvements across treatment arms in key noninvasive tests, including ELF and LSM, versus placebo. Of note, these data exhibited continued reductions from week 24 and provide evidence of continued improvement in antifibrotic activity with both treatment doses.

Efruxifermin Shows Potential for Fibrosis Reduction in Phase 2b MASH Cirrhosis Trial

Efruxifermin, a bivalent fibroblast growth factor 21 (FGF21) analogue being developed for the treatment of MASH, failed to significantly reduce fibrosis without worsening of MASH at 36 weeks in a phase 2b trial. Despite missing the trial’s primary endpoint, the 50 mg dose of efruxifermin may have possible benefit on fibrosis reduction at 96 weeks. Notably, efruxifermin also appeared to be associated with improvements in MASH-related histologic findings, noninvasive markers of liver injury and fibrosis, and markers of glucose and lipid metabolism.

CDC Changes Infant Hepatitis B Vaccine Recommendation

On December 5, 2025, the CDC ACIP voted 8 to 3 to recommend individual-based decision-making for parents deciding whether to give the hepatitis B vaccine, including the birth dose, to infants born to women who test negative for the virus.

For infants not receiving the birth dose, ACIP suggested in its recommendation that the initial dose be administered no earlier than 2 months of age. ACIP additionally voted to recommend that when evaluating the need for a subsequent hepatitis B vaccine dose in children, parents should consult with health care providers to decide whether to test antibody levels to hepatitis surface antigen to evaluate adequacy of protection through serology results.

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

Celebrating 1 Year of Resmetirom, Progress in MASH/MASLD

In honor of the 1 year anniversary of resmetirom’s FDA approval, a trio of expert hepatologists examined updates and unmet needs in the management of MASH and MASLD, highlighting resmetirom’s impact on disease management and looking ahead to what might be next in the pipeline.

Reflecting on Resmetirom’s Historic FDA Approval for MASH

Liver Lineup: Innovations in Cholestatic Disease Management, With Kris Kowdley, MD

Liver Lineup: Updates & Unfiltered Insights

, Nancy Reau, MD, sits down with Kris Kowdley, MD, to discuss evolving approaches in cholestatic liver disease, with a particular focus on PBC diagnosis and shifting treatment goals.

2025 in Hepatology: New MASLD Therapies, HBV Updates, and More

As part of HCPLive’s This Year in Medicine series, the editorial team of HCPLive Hepatology invited 7 leading experts to weigh in on the most important advances of 2025. Their responses ranged from the long-awaited arrival of effective pharmacologic treatments for MASLD/MASH to renewed innovation in viral hepatitis, cholestatic liver diseases, portal hypertension, and alcohol-associated liver disease, as well as emerging noninvasive diagnostics, evolving disease definitions, AI-enabled pathology, and increasingly patient-centered care models.

The year 2025 marked significant advancements in hepatology, characterized by regulatory milestones and therapeutic developments across various liver diseases. Key progress included the FDA's approval of glecaprevir/pibrentasvir for acute HCV and semaglutide for noncirrhotic MASH, emphasizing the role of metabolic therapies. The acceptance of FibroScan as a surrogate endpoint for MASH trials highlighted a shift towards noninvasive assessments. However, challenges persisted, such as the withdrawal of obeticholic acid for PBC. Policy changes, like the CDC's revised hepatitis B vaccine recommendations, further underscored the evolving landscape of hepatology.

The hepatology year in review highlights FDA approvals, MASH therapies, viral hepatitis advances, cholestatic disease shifts, and evolving clinical guidance.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

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.

Cholangitis

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

Hepatology 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.

Cardiology has seen rapid evolution over the past year, between the constant advancement of GLP-1 receptor agonists and a series of rapid-fire approvals from the 

 from various research organizations reinforced existing treatment algorithms and addressed gaps in disease management. And a new clinical definition of 

 as a disease rather than a risk factor established a path forward for managing one of the most critical epidemics facing cardiology.

Given the sheer volume of news released over the course of 2025, the editorial team at 

 has collected 11 of the most impactful headlines from the past 12 months. Catch up on any cardiology news you may have missed during this busy year below.


FDA Approves Vutrisiran (AMVUTTRA) for ATTR-CM


On March 20, 2025, vutrisiran received an expanded indication for the treatment of adults with cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM), making it the first RNAi therapeutic targeted to reduce cardiovascular mortality, cardiovascular hospitalizations, and urgent HF visits in ATTR-CM. The approval was based on the phase 3 HELIOS-B trial, where vutrisiran exhibited a 28% reduction in risk for all-cause mortality and recurrent cardiovascular events and a 33% reduction among patients receiving monotherapy. Vutrisiran also showed improvements in the 6-minute walk test and Kansas City Cardiomyopathy Questionnaire Overall Summary score compared to placebo.


FDA Approves Oral Semaglutide (Rybelsus) for CV Risk Reduction in Type 2 Diabetes


The FDA approved oral semaglutide 7 mg and 14 mg for cardiovascular risk reduction in patients with 

, irrespective of prior events, on October 17, 2025. This decision positioned oral semaglutide as the only GLP-1 medication currently available for reducing risk of major adverse cardiovascular events (MACE). Currently, oral semaglutide is prescribed in conjunction with diet and exercise to improve blood sugar in adults with T2D. The approval comes on the heels of positive results from the SOUL trial, during which oral semaglutide demonstrated a 14% relative reduction in MACE risk after 4 years compared to placebo.


FDA Approves Lerodalcibep-liga (Lerochol) for LDL-C Reduction in Hypercholesterolemia


Announced on December 15, 2025, the FDA approved of lerodalcibep injection for use as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. This novel, small protein-binding, third-generation PCSK9 inhibitor is intended as a once-monthly, single small-volume subcutaneous injection. The decision was based on results from the LIBerate program, a series of 5 global phase 3 registration studies. The latest of these, the LIBerate-HoFH trial, compared lerodalcibep to evolocumab, which proved the former’s noninferiority.


FDA Approves Aficamten (Myqorzo) for Symptomatic Obstructive Hypertrophic Cardiomyopathy


On December 19, 2025, the FDA approved aficamten in 5 mg, 10 mg, 15 mg, and 20 mg tablets for adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms. The allosteric and reversible cardiac myosin motor activity inhibitor proved its efficacy in the SEQUOIA-HCM trial, where it displayed substantially improved exercise capacity compared to placebo. Patients receiving aficamten exhibited increased peak oxygen uptake by 1.8 mL/kg/min, compared to 0 mL/kg/min in patients treated with placebo.


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


On July 14, 2025, Bayer announced the FDA’s approval of finerenone for adults with HF with a left ventricular ejection fraction (LVEF) ≥40%. Data from the FINEARTS-HF trial provided the backbone for the approval, with finerenone significantly reducing a composite endpoint of cardiovascular death or total HF events in a 16% relative risk reduction compared to placebo. Additionally, finerenone reduced HF hospitalizations by 18%. Additional analyses have suggested that these effects were present independent of ejection fraction, frailty, and age.

AHA & ACC Release New Guidelines for High Blood Pressure to Reduce CVD Risk


On August 14, 2025, the American Heart Association (AHA) and the American College of Cardiology (ACC) released a joint guideline encouraging earlier treatment for high blood pressure to reduce cardiovascular disease risk. The publication suggests physical activity, heart-healthy diets, and stress management to reduce the risk of heart attack, 

, and HF. Additionally, the comprehensive list of guidelines includes limiting sodium and alcohol intake, home blood pressure monitoring, and undergoing regular screening for primary aldosteronism.


The Lancet Commission on Obesity: Redefining Endocrinology’s Most Notorious Condition

 published a commission aiming to define obesity as a clinical disease in addition to its status as a risk factor. The Commission separated obesity into preclinical – wherein the condition is a risk factor for other diseases – and clinical – when obesity itself is a standalone illness. It also addressed diagnostic issues surrounding obesity, as body mass index has long been known to be unreliable at best. The Commission suggests clinicians confirm excess adiposity through 2 individual anthropometric criteria, such as waist circumference, or via direct fat measurement when possible.


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


On August 13, 2025, the Heart Failure Society of America (HFSA) and the American Society for Preventive Cardiology (ASPC) released a joint statement calling for a shift in how clinicians approach treating HF. The statement emphasizes the importance of prevention and risk identification, stating that HF should not be viewed as an inevitable outcome but an avoidable disease. Ultimately, the guidelines broke down 4 primary components of HF prevention: early risk identification, holistic care, proven therapies, and system-wide change. They emphasize that all 4 are critical to adopting a more proactive approach.

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

, moderator James Januzzi, MD, is joined by Martha Gulati, MD, MS, and Anu Lala, MD, to discuss the August 13 joint statement from the ASPC and HFSA on preventive care for HF. During the series, Gulati and Lala note the growing prevalence of the HF epidemic, along with ballooning costs, despite being largely preventable. This new publication, and thus this special report, seeks to unify HF care and preventive cardiology.


Don’t Miss a Beat: SURPASS-CVOT and Tirzepatide, a Dual GIP/GLP-1 RA, in ASCVD


In this episode, cohosts Stephen Greene, MD, and Muthiah Vaduganathan, MD, MPH, met with Darren McGuire, MD, to discuss the groundbreaking SURPASS-CVOT trial. This was the first study to directly compared 2 incretin-based therapies in patients with T2D and established atherosclerotic cardiovascular disease (ASCVD). Additionally, the trial’s unique design combined traditional noninferiority testing with an imputed placebo approach, which draws on prior GLP-1 placebo-controlled trial data to infer superiority versus placebo – SURPASS-CVOT is the first time this methodology has been formally accepted into cardiometabolic research.


ACC/AHA Hypertension Guideline Update: Recommendations for Managing Blood Pressure

The updated ACC/AHA hypertension guidelines, released on August 14, 2025, aim to emphasize early intervention and more proactive approaches to hypertension care. New therapies like GLP-1 receptor agonists and aprocitentan are highlighted in the document; however, many clinicians have suggested caution in applying these recommendations given comparatively limited testing. In this video, the 

 editorial team met with 3 leading cardiologists – Manesh Patel, MD, Vivek Bhalla, MD, and Viet Le, DMSc, PA-C – to discuss the implications of these guidelines and how both clinicians and patients can adapt their hypertension care plans.

Cardiology has experienced significant advancements, including FDA approvals of novel treatments and updated clinical guidelines. Key developments include the approval of vutrisiran for ATTR-CM, oral semaglutide for cardiovascular risk reduction in type 2 diabetes, lerodalcibep for LDL-C reduction, aficamten for obstructive hypertrophic cardiomyopathy, and finerenone for heart failure with preserved ejection fraction. New guidelines from the AHA and ACC emphasize early intervention in hypertension, while The Lancet redefines obesity as a disease. The HFSA and ASPC advocate for a preventive approach to heart failure management.

Catch up on the most impactful headlines in cardiology 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...

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Cardiology in 2025: Year in Review

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


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

Over the past several years, specialty medicine has entered a period of sustained acceleration, characterized by an expanding volume of late-stage clinical data, an increasing number of regulatory submissions, and a growing diversity of therapeutic mechanisms reaching the

Advances that once unfolded gradually are now arriving in rapid succession, requiring clinicians, researchers, and health system leaders to reassess standards of care across multiple disease areas continuously. For many in the medical community, keeping pace with this evolution has become an ongoing challenge, as meaningful regulatory decisions and practice-shaping data emerge with increasing frequency.

This momentum is expected to carry forward into early 2026, with the first quarter shaping up to be particularly active across several specialty fields. Multiple FDA decisions anticipated during this period have the potential to introduce first-in-class therapies, expand treatment options for conditions with long-standing unmet need, and further refine regulatory expectations around clinically meaningful endpoints. In this article, we highlight 5 FDA decisions to watch in the coming months, each representing a potential inflection point in its respective disease area. Together, these decisions, listed below in chronological order, underscore both the opportunities and the complexity facing specialty care as therapeutic innovation continues to accelerate.

Company: Travere Therapeutics
PDUFA date: January 13, 2026
Indication: Focal Segmental Glomerulosclerosis

A decision on sparsentan (Filspari) is expected from the US FDA by January 13, 2026. Sparsentan, a dual endothelin A receptor and angiotensin II type 1 receptor antagonist from Travere Therapeutics, was assessed in the phase 3 DUPLEX Study and phase 2 DUET Study, which demonstrated rapid, sustained reductions in proteinuria compared with maximally dosed irbesartan. The FDA accepted Travere’s supplemental New Drug Application for traditional approval in May 2025, initially indicating plans for an advisory committee meeting, which the agency later determined was no longer necessary as of September 10, 2025. If approved, sparsentan would become the first FDA-approved therapy specifically indicated for focal segmental glomerulosclerosis (FSGS).

: FSGS remains a leading cause of kidney failure with no approved disease-specific therapies, leaving clinicians reliant on off-label and often poorly tolerated options. Approval of sparsentan would establish proteinuria reduction as a validated regulatory endpoint in FSGS and provide a non-immunosuppressive, oral treatment option for both adult and pediatric patients at risk of progression.

Understanding Sparsentan in Pediatric FSGS, With Michelle Rheault, MD

2. Sublingual Epinephrine Film (Anaphlym)

Company: Aquestive Therapeutics
PDUFA date: January 31, 2026
Indication: Type 1 Allergic Reactions
Summary: 

A decision on epinephrine sublingual film (Anaphylm) is expected from the US FDA by January 31, 2026. Epinephrine sublingual film, a polymer matrix–based epinephrine prodrug delivered via sublingual film from Aquestive Therapeutics, was assessed in an Oral Allergy Syndrome challenge study and supporting adult and pediatric pharmacokinetic and safety studies, which demonstrated rapid symptom resolution beginning within 2 minutes of administration and pharmacokinetic profiles comparable to traditional epinephrine exposure. The FDA accepted the New Drug Application on June 16, 2025, following positive pre-NDA feedback in December 2024 and completion of a pediatric study announced in April 2025, and assigned a PDUFA target action date of January 31, 2026.

: Anaphylaxis remains a life-threatening condition in which delayed or avoided epinephrine administration is a major contributor to morbidity and mortality, often driven by fear of needles and poor device adherence. Approval of epinephrine sublingual film could alter emergency allergy care by introducing the first orally delivered, device-free epinephrine option, potentially improving real-world access, carriage, and timely treatment across pediatric and adult populations.


Sublingual Epinephrine Film Well Tolerated in Children, With David Golden, MD

Company: Ascendis Pharma
PDUFA date: February 28, 2026
Indication: 

 A decision on TransCon CNP (navepegritide) is expected from the US FDA by February 28, 2026, following a 3-month PDUFA extension announced November 25, 2025, due to a major amendment submitted on November 5, 2025, related to post-marketing requirements. TransCon CNP, a once-weekly investigational prodrug of C-type natriuretic peptide (CNP) from Ascendis Pharma, was assessed in the pivotal phase 3 ApproaCH trial and additional randomized, placebo-controlled studies, which demonstrated increased growth velocity alongside improvements in muscle strength, leg bowing, and health-related burden with a safety profile comparable to placebo. The New Drug Application was originally submitted in 2025, and Ascendis is also planning submission of a European Marketing Authorisation Application in Q3 2025. If approved, TransCon CNP would expand the therapeutic landscape for pediatric achondroplasia with a long-acting, systemic CNP replacement strategy.

: Achondroplasia is a multisystem genetic condition associated with lifelong skeletal, neurologic, respiratory, and functional complications, and current treatment options remain limited. Approval of TransCon CNP could represent a shift toward disease-modifying therapy that addresses not only linear growth but also broader functional and quality-of-life outcomes in affected children.


The Latest on Navepegritide for Children with Achondroplasia, with Carlos Bacino, MD

Company: Bristol Myers Squibb
PDUFA date: March 6, 2026
Indication: Psoriatic Arthritis
Summary: 

A decision on deucravacitinib (Sotyktu) is expected from the US FDA by March 6, 2026. Deucravacitinib, a selective oral tyrosine kinase 2 (TYK2) inhibitor from Bristol Myers Squibb, was assessed in the phase 3 POETYK PsA-1 and POETYK PsA-2 trials, which demonstrated statistically significant improvements in ACR20 response at week 16 versus placebo, along with favorable skin, functional, and quality-of-life outcomes. The FDA accepted the supplemental New Drug Application in July 2025. If approved, deucravacitinib would become the first TYK2 inhibitor indicated for psoriatic arthritis, expanding on its September 2022 FDA approval for moderate-to-severe plaque psoriasis.

 Psoriatic arthritis remains a heterogeneous, progressive disease with persistent unmet need for effective oral therapies that balance efficacy with long-term safety. Approval of deucravacitinib could introduce a differentiated oral mechanism distinct from JAK inhibition, offering clinicians an earlier-line systemic option with a safety profile that may be better suited for long-term disease management.


Deucravacitinib, Zasocitinib Validate TYK2 Inhibition in PsA, With Philip Mease, MD

Company: GSK
PDUFA date: March 24, 2026
Indication: 

Cholestatic Pruritus in Primary Biliary Cholangitis


A decision on linerixibat is expected from the US FDA by March 24, 2026. Linerixibat, an ileal bile acid transporter (IBAT) inhibitor from GSK, was assessed in the phase 3 GLISTEN trial, demonstrating clinically meaningful reductions in moderate to severe cholestatic pruritus and associated quality-of-life burden in patients with primary biliary cholangitis (PBC). The FDA accepted the New Drug Application in June 2025, positioning linerixibat as a potential symptom-directed therapy amid a rapidly evolving PBC treatment landscape following the 2024–2025 approvals of seladelpar and elafibranor. If approved, linerixibat would be the first therapy specifically indicated for PBC-associated pruritus in the United States, according to GSK.

 Despite recent disease-modifying approvals, up to half of patients with PBC continue to experience moderate to severe pruritus, a symptom strongly linked to impaired sleep, mental health, and overall quality of life. A targeted antipruritic option such as linerixibat could address a critical residual unmet need that remains largely refractory to current PBC therapies.


GLISTEN: Linerixibat Improves Biomarkers and Itch in Patients With PBC, With Andreas Kremer, MD, PhD, MHBA

Travere Therapeutics. Travere Therapeutics Provides Update on FDA Advisory Committee Meeting for FILSPARI® (sparsentan) in FSGS. September 10, 2025. Accessed September 10, 2025. 

https://ir.travere.com/press-releases/news-details/2025/Travere-Therapeutics-Provides-Update-on-FDA-Advisory-Committee-Meeting-for-FILSPARI-sparsentan-in-FSGS/default.aspx

Aquestive Therapeutics. Aquestive Therapeutics Announces FDA Acceptance of New Drug Application and PDUFA Date for Anaphylm™ for the Treatment of Severe Allergic Reactions. June 16, 2025. Accessed June 19, 2025. 

https://investors.aquestive.com/news-releases/news-release-details/aquestive-therapeutics-announces-fda-acceptance-new-drug-0

Ascendis Pharma. Ascendis Announces Extension of FDA Review Period for TransCon CNP (navepegritide) for Children with Achondroplasia | Ascendis Pharma. Ascendispharma.com. Published November 25, 2025. Accessed December 24, 2025. 

https://investors.ascendispharma.com/news-releases/news-release-details/ascendis-announces-extension-fda-review-period-transcon-cnp

Bristol Myers Squibb’s Supplemental New Drug Application (sNDA) for Sotyktu (deucravacitinib) for the Treatment of Adults with Active Psoriatic Arthritis Accepted for Review Across Four Regions Globally. News release. Bristol Myers Squibb. July 21, 2025. 

Specialty medicine is experiencing rapid advancements, with increasing late-stage clinical data and regulatory submissions. This acceleration necessitates continuous reassessment of care standards across various disease areas. The momentum is expected to persist into early 2026, with significant FDA decisions anticipated in the first quarter. These decisions could introduce first-in-class therapies, expand treatment options for unmet needs, and refine regulatory expectations. Key decisions include sparsentan for FSGS, sublingual epinephrine film for allergic reactions, navepegritide for achondroplasia, deucravacitinib for psoriatic arthritis, and linerixibat for cholestatic pruritus in PBC.

Explore five pivotal FDA decisions set for early 2026 that could transform specialty medicine and enhance treatment options across various conditions.

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