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.

Articles

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.

News

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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.

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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. 

https://news.bms.com/news/details/2025/Bristol-Myers-Squibbs-Supplemental-New-Drug-Application-sNDA-for-Sotyktu-deucravacitinib-for-the-Treatment-of-Adults-with-Active-Psoriatic-Arthritis-Accepted-for-Review-Across-Four-Regions-Globally/default.aspx

GSK. Linerixibat New Drug Application (NDA) accepted for review by the US FDA for cholestatic pruritus in patients with primary biliary cholangitis (PBC) | GSK. Gsk.com. Published June 2, 2025. Accessed December 24, 2025. 

https://www.gsk.com/en-gb/media/press-releases/linerixibat-new-drug-application-nda-accepted-for-review-by-the-us-fda

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.

Focal Segmental Glomerulosclerosis

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

Anaphylaxis

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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.

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Q1 2026 Preview: 5 FDA Decisions to Watch in Specialty Care

Lana Pine is the editor of HCPLive Rheumatology. She is an experienced editor and technical writer with a demonstrated history of working in the banking and publishing industries. In her free time, she enjoys cooking, yoga, listening to podcasts, and drawing. She can be reached via email at LPine@mjhlifesciences.com.

This feature contribution to our This Year in Medicine series comes 

—a sister publication of HCPLive dedicated to providing expert-driven resources to promote health literacy and inform patients.

Health information is everywhere. Patients can look up symptoms, medications, side effects, and treatment options in seconds before they ever speak with a clinician. While this access has empowered many people to take a more active role in their health, clinicians across specialties say it has also created a serious and growing challenge: health misinformation that shapes decisions, delays care, and undermines trust.

From psychiatry to cardiology to primary care, misinformation is no longer an occasional hurdle. It is now a routine part of patient care, influencing how people understand risk, interpret recommendations, and decide whether to pursue treatment at all.

This Year in Medicine 2025: The Hidden Cost of Health Misinformation clip from Educated Patient

This Year in Medicine 2025: The Hidden Cost of Health Misinformation

Misinformation Doesn’t Affect Every Patient the Same Way

Clinicians emphasize that misinformation does not affect all patients equally. Its impact depends on a patient’s health literacy, prior experiences with the healthcare system, and, in some cases, their mental health.

In psychiatry, misinformation can be especially complex. Richard Miller, MD, a psychiatrist, explains that the seriousness of the issue varies widely depending on the patient. Some patients arrive with lists of online findings and questions, while others may not engage with digital information at all. As he puts it, “I think the answer is variable. I think it really depends.”

What clinicians consistently see, however, is that patients often encounter information without the context needed to understand it correctly. A warning meant for a specific population can be misinterpreted as a universal danger. A single phrase or headline can take on outsized meaning.

Miller described a recent encounter in which a patient feared a medication would cause dementia. These worries were based not on a medical discussion, but on an advertisement. “She thought it was going to cause dementia, so you’ve got to be careful,” he said, explaining how easily warnings can be misunderstood once they circulate outside of clinical context.

How Misinformation Changes Medical Decisions

Across specialties, clinicians describe a common pattern: misinformation alters how patients perceive risk. Proven therapies may feel dangerous, while the risks of delaying or avoiding care are minimized or overlooked.

In cardiology and preventive medicine, this shift can be particularly harmful. Many treatments are designed to reduce long-term risk rather than provide immediate relief. When misinformation leads patients to stop or avoid these therapies, the consequences may not be visible right away, but they can be devastating over time.

Viet Le, DMSc, PA-C, a preventive cardiology clinician and researcher, sees this frequently. “We have people who are stopping the therapies, deciding not to move forward with recommendations to start therapies,” he said. In his view, the stakes are high: “I don't think it's a far stretch to say people are dying based on misinformation that they should be alive.”

Primary care physicians often encounter the downstream effects years later. Patients with long-standing hypertension, diabetes, or high cholesterol may come in after trying unproven approaches, only to find their condition has progressed. Jubril Oyeyemi, MD, a primary care physician and founder of the Cherry Hill Free Clinic, described seeing patients whose care was delayed because trust had been undermined. “There's harm in it, there's direct harm,” he said.

One of the most challenging aspects of misinformation is when patients encounter it. When incorrect information comes first (before a clinical visit) it can shape how patients interpret everything that follows.

Le explains that misinformation often takes root early. “When misinformation gets out in front before you see your clinician…it takes a lot more time to overcome that,” he said. Clinicians may spend much of an appointment correcting misconceptions before they can even begin discussing next steps.

This dynamic is familiar to many parents, Le noted, likening it to correcting something a child heard from peers or online. Once an idea is planted, it takes time, trust and repetition to undo.

At the heart of health misinformation is trust — or the lack of it. Misinformation often undermines confidence in clinicians, medical institutions, and evidence-based care.

Oyeyemi sees this erosion of trust play out daily in primary care, particularly among patients managing chronic conditions. He emphasized that patients always have the right to decline treatment, but only if that decision is based on accurate information. “Refusing is not the problem. It's that the refusal is based on misinformation,” he said.

Clinicians stress that trust is built through relationships. Patients who have long-standing relationships with providers are often more comfortable asking questions and expressing concerns. Newer relationships, or those shaped by past negative experiences, can make patients more susceptible to external voices that feel more validating.

This Year in Medicine 2025: The Hidden Cost of Health Misinformation Clip 2

Today, clinicians are no longer just providers of medical care, they are interpreters of information. Patients often arrive having consumed large volumes of health content, and clinicians must help them sort what is relevant, accurate, or misleading.

Miller described this role as helping put information into context, repeatedly emphasizing the importance of understanding where a patient is coming from. Clinicians must consider cultural background, trauma history, and individual beliefs, all factors that algorithms cannot account for.

Le argues that clinicians also need to be proactive beyond the exam room. “We should be proactive in being in the social media space, being where our patients are,” he said, adding that healthcare systems and clinicians have a responsibility to provide accurate, accessible information before misinformation fills the gap.

Rather than discouraging patients from using technology or AI tools, many clinicians now encourage guided curiosity. As Le put it, “We have an engaged patient who's curious and who wants to know. Let's lean into that.”

Clinicians agree that patients are not powerless in the face of misinformation. There are concrete steps people can take to become more informed and critical consumers of health information.

First, start with trusted sources. Professional medical organizations, national societies, and reputable patient advocacy groups collaborate with experts and rely on evidence-based data. These sources are far more reliable than viral videos or anecdotal stories.

Second, pause before acting. Oyeyemi urges patients to slow down before adopting a new supplement, therapy, or lifestyle change. He notes that even seemingly benign products can carry risks or interact with medications.

Third, talk to a trusted healthcare provider. Clinicians repeatedly emphasize that no question is too small. Personalized guidance based on an individual’s medical history, family history, and goals cannot be replaced by generalized online advice.

Finally, Oyeyemi warns patients to “be wary of absolutes,” especially claims that promise cures for everyone or everything.

Another theme clinicians emphasize is the need to accept uncertainty. Medical knowledge evolves. Recommendations change as new evidence emerges. This is not a failure of medicine; it is how science works.

Le encourages patients to be comfortable with this reality. “We're still learning things, and we're unlearning things,” he said. The goal is not perfection, but progress grounded in the scientific method.

In the ideal scenario, healthcare decisions are made through shared decision-making, where evidence, clinical expertise, and patient values all play a role. As Oyeyemi summarized, the goal is for decisions to be made through “trusted relationships, shared decision making, and evidence, not algorithms or viral posts.”

Health misinformation is unlikely to disappear. As technology advances, the volume of information (both accurate and inaccurate) will only grow. Clinicians say the solution is not to restrict access, but to strengthen relationships.

Trust, context, and open dialogue remain the most powerful tools in healthcare. When patients feel heard and respected, they are better equipped to navigate an overwhelming information landscape.

The proliferation of health information online has empowered patients but also introduced significant challenges due to misinformation, affecting patient decisions and trust in healthcare. Misinformation impacts patients differently based on their health literacy and experiences, often leading to misinterpretation of risks and treatment options. Clinicians now play a crucial role in contextualizing information and building trust. They encourage patients to rely on credible sources, engage in open dialogue, and accept medical uncertainties. Strengthening patient-clinician relationships is essential to navigating the complex information landscape effectively.

Clinicians across specialties explain how health misinformation is reshaping patient decisions, delaying care, and undermining trust.

This Year In Medicine

The Hidden Cost of Health Misinformation

 is a double board-certified psychiatrist and addictionologist, and the medical director of 

and a nationally recognized advocate for trauma-informed, evidence-based care

 has shifted again. It no longer looks like a needle or a bag of powder. It looks like a THC vape a teenager buys from a friend. It looks like a cartridge sold behind the counter of a gas station. It looks like a pill ordered online that arrives in packaging designed to feel harmless. In the adolescent units I lead and the treatment centers I walk every morning, these items move through the hands of young people who have no idea what is hidden inside.

I am not speaking in hypotheticals. I am speaking from the rooms where the shock lands. I talk to parents whose sons and daughters never made it to an emergency department. Their children died in bedrooms and dorms and parked cars with no warning at all. EMS often arrives at a scene that feels frozen, the overdose already past the point of return. Families believed they were dealing with occasional cannabis use. The toxicology says otherwise. It reveals synthetic opioids far more potent than anything they had ever imagined.

These compounds are appearing in places no parent would ever suspect. Nitazenes (extremely potent synthetic opioids) are now being hidden inside cartridges marketed as THC. Kratom derivatives like 7-OH are chemically reshaped into substances that bear little resemblance to the plant they came from. Counterfeit pills are arriving through online marketplaces with extraordinary ease. A teenager sees a familiar color or logo and believes they know what they are taking. There is nothing in the appearance that tells them they are holding a lethal analog designed in a clandestine lab.

Not long ago, I admitted a young woman who collapsed minutes after using what she thought was cannabis. Her breathing failed almost instantly. She lived only because someone acted immediately. The toxicology later confirmed a nitazene analog. Her case is not an anomaly. It is a signal. These events are happening quietly and quickly, far from public view.

Healthcare professionals must recalibrate their instincts. Any unknown vape exposure should be treated as a potential opioid poisoning until proven otherwise. We cannot rely on assumptions. We must have naloxone immediately available and be prepared for repeated dosing. If an adolescent presents with sudden respiratory collapse and a history of vaping, opioid toxicity belongs at the top of the differential.

Detection capabilities must evolve as quickly as the chemistry. Real-time aerosol analysis for emerging analogs is becoming essential. Without it, we are operating blind while the compounds become more sophisticated.

Parents and teenagers deserve clarity. No illicit THC vape is safe. No street cartridge is predictable. Testing strips do not detect nitazenes. Education must be direct, repetitive, and impossible to misunderstand.

There is a final truth we must name. This is not an accidental trend. It is a multi-billion-dollar operation moving through transnational pipelines that cut across the southern border, the Caribbean corridors, and the ports along our eastern seaboard. These compounds are not drifting into our communities. They are being delivered with intent. This is an assault on our youth and on the stability of our country. If we fail to respond with precision and urgency, the cost will be measured in families who never had the chance to say goodbye.

. He is board-certified in psychiatry and addiction medicine. He earned his medical degree from the University of Tennessee Health Science Center and an MPH in international health and transnational operations from Tulane University’s School of Public Health.

The opioid crisis has evolved, with synthetic opioids like nitazenes hidden in products such as THC vapes and counterfeit pills, posing a significant threat to adolescents. These substances are often undetectable and lead to fatal overdoses, as seen in cases where young individuals unknowingly consume lethal analogs. Healthcare professionals must adapt by treating unknown vape exposures as potential opioid poisonings and ensuring naloxone is readily available. The crisis is driven by a deliberate, multi-billion-dollar operation, necessitating urgent and precise responses to protect youth and national stability.

Potent synthetic opioids are being disguised in everyday products—from THC vapes to counterfeit pills—putting teens at unseen, lethal risk.

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