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

Welcome back to our recap of this month's news and updates from the 

November brought a series of impactful FDA decisions spanning rare disease, pediatrics, neuromuscular disorders, and cardiometabolic care—each marking a meaningful expansion in therapeutic options for historically underserved patient populations. The month opened with the approval of doxycitine and doxribtimine (Kygevvi), the first treatment for thymidine kinase 2 deficiency, offering survival and functional benefits in an ultra-rare mitochondrial disorder with no prior therapies. Soon after, linaclotide became the first FDA-approved option for pediatric irritable bowel syndrome with constipation (IBS-C) in patients ≥7 years old, supported by efficacy signals consistent with adult outcomes. Mid-month, the agency issued significant safety-driven changes to ELEVIDYS, restricting its use to ambulatory patients with Duchenne muscular dystrophy (DMD) and adding a Boxed Warning following reports of acute liver failure in non-ambulatory recipients.

Regulators also advanced innovation in lipid and renal disease. The approval of plozasiran introduced the first apoC-III–targeting siRNA therapy for familial chylomicronemia syndrome, offering meaningful reductions in triglycerides, apoC-III, and pancreatitis risk with quarterly dosing. Closing the month, sibeprenlimab received accelerated approval for IgA nephropathy after demonstrating a more than 50% placebo-adjusted reduction in proteinuria at one year, adding momentum to a rapidly evolving treatment landscape ahead of confirmatory eGFR data. Collectively, these decisions signal an FDA increasingly focused on precision mechanisms and high-need populations across a diverse therapeutic spectrum. Here’s a concise overview of the key FDA decisions and updates from November 2025.

Want to hear from the experts? Look for our Related Content links underneath blurbs for insight into how this decision might influence practice moving forward.

FDA Approves Kygevvi, First Treatment for Thymidine Kinase 2 Deficiency

On November 3, 2025, UCB announced the FDA approved doxycitine and doxribtimine (Kygevvi) as the first therapy for thymidine kinase 2 deficiency (TK2d). Based on phase 2 clinical data, retrospective analyses, and an expanded access program, Kygevvi demonstrated improved survival and functional outcomes, including markedly lower mortality compared with untreated patients. The combined nucleoside therapy supports mitochondrial DNA replication and skeletal muscle function in this ultra-rare mitochondrial disorder.

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

On November 5, 2025, Ironwood Pharmaceuticals announced the FDA approved linaclotide (Linzess) for pediatric patients ≥7 years of age with irritable bowel syndrome with constipation (IBS-C), making it the first therapy authorized for IBS-C in this age group. Based on extrapolated adult efficacy data and a 12-week randomized pediatric trial, linaclotide 145 mcg once daily demonstrated reductions in abdominal pain and increases in spontaneous bowel movements consistent with adult outcomes. The safety profile was similar to that observed in adults, with diarrhea reported as the most common adverse event.

FDA Issues New Boxed Warning, Limiting ELEVIDYS to Ambulatory DMD

On November 14, 2025, the FDA announced new safety warnings and labeling revisions for delandistrogene moxeparvovec-rokl (Elevidys), restricting its indication to ambulatory patients with Duchenne muscular dystrophy.

Based on postmarketing safety reports, including fatal cases of acute liver failure in non-ambulatory recipients, the agency added a Boxed Warning for serious liver injury and mandated a postmarketing observational study with serial liver function monitoring. Updated guidance includes enhanced recommendations for hepatic and cardiac monitoring, cautions regarding corticosteroid-associated risks, and new contraindications for certain patient populations.

FDA Approves Plozasiran for Adults With Familial Chylomicronemia Syndrome

On November 18, 2025, Arrowhead Pharmaceuticals announced the FDA approved plozasiran (Redemplo) for reducing triglycerides in adults with familial chylomicronemia syndrome (FCS). Based on the phase 3 PALISADE trial and supportive phase 2 SUMMIT data, plozasiran significantly lowered fasting triglycerides and apoC-III levels and reduced acute pancreatitis risk, with dosing once every 3 months. The small-interfering RNA therapeutic demonstrated a favorable tolerability profile and represents the first approved therapy targeting apoC-III reduction for FCS.

RX Review: Leveraging siRNA in FCS Management

FDA Awards Accelerated Approval to Sibeprenlimab in IgA Nephropathy

On November 25, 2025, Otsuka Pharmaceutical announced the FDA approved sibeprenlimab (Voyxact) to reduce proteinuria in adults with primary IgA nephropathy at risk for disease progression. Based on results from the phase 3 VISIONARY trial, sibeprenlimab produced a 54.3% placebo-adjusted reduction in 24-hour urine protein-to-creatinine ratio after 12 months, with consistent effects across clinical subgroups. The APRIL-targeting antibody adds to the growing therapeutic landscape for IgA nephropathy and received accelerated approval pending full 2-year eGFR results expected in 2026.

Kidney Compass: Sibeprenlimab and the VISIONARY Trial, with Vlado Perkovic, MBBS, PhD, at ERA 2025

Articles

November saw significant FDA decisions enhancing therapeutic options for underserved populations, including rare diseases, pediatrics, and cardiometabolic care. Key approvals included Kygevvi for thymidine kinase 2 deficiency, linaclotide for pediatric IBS-C, and plozasiran for familial chylomicronemia syndrome. Safety updates for ELEVIDYS restricted its use to ambulatory Duchenne muscular dystrophy patients. Sibeprenlimab received accelerated approval for IgA nephropathy, marking progress in precision medicine. These decisions reflect the FDA's focus on precision mechanisms and high-need populations across diverse therapeutic areas.

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

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5 FDA Headlines You Missed in November 2025

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

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

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has voted 8 to 3 to overturn the universal recommendation to start hepatitis B immunization at birth.

With the decision, individual-based decision-making is recommended 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 suggests in its recommendation that the initial dose be administered no earlier than 2 months of age.

The votes were preceded by December 4, 2025, presentations to ACIP on the hepatitis B disease burden, vaccine safety, and comparative nation immunization policies as well as briefings from representatives of the vaccine manufacturers.

In response to these presentations, the Hepatitis B Foundation released a statement expressing disappointment and concern about discussions during the meeting, a lack of transparency, and a “specific agenda” held by Committee members.

, Chari Cohen, DrPH, MPH, president of the Hepatitis B Foundation, elaborated on some of the points made in the statement, citing a shortened public comment period, confusion regarding what date the meeting was being held, and presentations from external sources rather than the CDC.

“Throughout the day, we saw this trend where when strong scientific data were brought up, somehow it was either ignored or dismissed, and that was very concerning,” Cohen added.

She went on to describe the importance of the universal birth dose of the hepatitis B vaccine and the role it plays in protecting against mother-to-child transmission and protecting infants from accidental exposure during infancy or early childhood.

While Cohen acknowledged the importance of shared decision-making and the role it already plays in healthcare, she pointed out that risk-based implementation has not worked in the context of hepatitis B vaccination in the past. From 1982 to 1991, risk-based hepatitis B vaccination strategies were largely ineffective, with the eventual transition to universal childhood vaccination helping to curb rates of infection.

“I think that pediatricians are going to need to know how to talk to parents about this, how to accurately and clearly state the information on safety to parents and help them make a decision based on science, which isn't always easy to do,” Cohen said. “I don't envy pediatricians. It's going to be really hard to translate some of this information, especially when it's really hard to justify the decision that was made.”

Editors’ Note: Cohen reports relevant disclosures with Gilead Sciences, GlaxoSmithKline, Vir Biotechnology, Dynavax Technologies, and Roche.

Brooks A. CDC Changes Infant Hepatitis B Vaccine Recommendation. HCPLive. December 5, 2025. Accessed December 5, 2025. 

https://www.hcplive.com/view/cdc-changes-infant-hepatitis-b-vaccine-recommendation

CDC. Achievements in Public Health: Hepatitis B Vaccination --- United States, 1982--2002. 

https://www.cdc.gov/mmwr/preview/mmwrhtml/mm5125a3.htm

Videos

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

Hepatology

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a psychiatrist and Chief Medical Officer at HMNC Brain Health

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

Each year, research on the use of artificial intelligence (AI) in healthcare continues to grow, tracing back to the 1970s with MYCIN, an early system designed to recommend treatments for blood infections.

But with the rise of chatbots like ChatGPT, AI has become even more top-of-mind for many people.

Digital Health Advisory Committee (DHAC) met on November 20, 2025, for its second meeting dedicated to AI-enabled content in medical devices

The agency addressed several AI risks, including output errors, misinterpretations of what a chatbot says, and healthcare providers' lack of understanding of how to effectively monitor the technology. Yet, at the same time, AI tools improve access to care.

A report released shortly afterward outlined the FDA’s expectations for AI: rigorous performance testing (assessing repeatability, reproducibility, uncertainty, hallucination rates, and error rates); ongoing automated auditing and quality assurance after market entry; and strong human oversight, training, transparency, informed use, shared responsibility, and risk-management practices. The agency also emphasized the importance of detailed device submissions that specify the intended use, care environment, and standardized model cards, as well as benchmarking to compare device performance against established standards.

This regulatory backdrop frames HMNC Brain Health’s work in the OLIVE trial, which is testing an AI-assisted, genetically guided precision approach for 

 The company announced pivotal data on August 5, 2025.

“I think we all feel a bit uneasy about AI,” Hans Eriksson, PhD, MD, from HMNC Brain Health, told 

. “How do we ensure that what we get is accurate, that what we get is not just made up by a machine? But in our case, the AI component is…earlier on. The AI component was used…to map the result of this physiological challenge test to a certain outcome of a genetic test. For the individual patient, there is no real AI component involved [once the blood is drawn]. That happened before the algorithm was created.”

OLIVE, a randomized, double-blind, placebo-controlled phase 2b trial, evaluated BH-200 (nelivaptan), a selective vasopressin V1b receptor antagonist, in patients with MDD. BH-200 produced a clinically meaningful improvement, with separation from placebo on HAM-D17 emerging at week 4 (

 By week 8, the mean difference between BH-200 and placebo reached –2.98 (

This study used HMNC’s proprietary genetic selection tool, which classifies patients based on biomarkers linked to vasopressin signaling and regulation of the hypothalamic-pituitary-adrenal (HPA) axis. The tool sorted patients into 3 vasopressin-related biological subgroups

Findings showed that lower peripheral vasopressin activity correlates with stronger central vasopressin activity in relevant brain areas, resulting in a more robust antidepressant response. This finding confirms that a genetic test can guide patient selection for BH-200.

Previous vasopressin blockers reached large clinical trials before but were never approved, likely because only a subset of patients had the underlying HPA-axis disturbance these drugs target. In broad, unselected populations, treatment effects were diluted.

To identify the right patients, investigators once relied on a “cumbersome” physiological challenge test requiring hospitalization, a synthetic steroid, a CRH injection, and repeated blood draws, according to Eriksson. Conducted in about 400 patients at the Max Planck Institute of Psychiatry in Munich, the test helped link specific vasopressin-related genes to test outcomes. Investigators then used these data to map physiological responses to distinct genetic profiles.

“We do not have to run the test [anymore]; we just draw blood from the patients, send it for genetic analysis, and a few days later, it comes back,” Eriksson said. “In the first version of the test, it came back with 3 different [responding] groups: high, medium, [and] low. But the intention is to…further refine this test, so it will actually answer yes or no to the question… ‘is this patient a suitable candidate for this treatment?”’

The Evolution of AI in Healthcare. Xsolis. Published February 2, 2021. 

https://www.xsolis.com/blog/the-evolution-of-ai-in-healthcare/

Eriksson H. FDA Examines Generative AI in Psychiatry, With Hans Eriksson, MD, PhD. Hcplive.com. Published December 5, 2025. Accessed December 5, 2025. 

https://www.hcplive.com/view/fda-examines-generative-ai-psychiatry-hans-eriksson-md-phd

HMNC BRAIN HEALTH | a disruptive clinical stage biopharma company pioneering precision psychiatry. Hmnc-brainhealth.com. Published 2025. Accessed December 5, 2025. 

https://www.hmnc-brainhealth.com/news/HMNC-Brain-Health-Announces-Phase-2-Results-from-OLIVE-Trial-in-Major-Depressive-Disorder-MDD-with-Genetically-Guided-Precision-Approach

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

Psychiatry

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

Abigail Brooks is an assistant managing editor for 

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

The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has 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.

According to a December 5, 2025, release from the CDC, for infants not receiving the birth dose, ACIP suggests 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.

Previously, CDC recommendations stated that all infants should receive a dose of hepatitis B vaccine at birth, regardless of the HBV infection status of the birth parent.

"The American people have benefited from the committee's well-informed, rigorous discussion about the appropriateness of a vaccination in the first few hours of life," Deputy Secretary of Health and Human Services and CDC Acting Director Jim O'Neill said in a statement.

The votes were preceded by December 4, 2025, presentations to ACIP on the hepatitis B disease burden, vaccine safety, and comparative nation immunization policies as well as briefings from representatives of the vaccine manufacturers. Specifically, a presentation from Cynthia Nevison, PhD, on the decline of the hepatitis B disease burden since 1985 concluded that the universal birth dose contribution to acute case decline is likely small, identifying sharp declines in post-transfusion hepatitis B transmission due to advanced blood screening, improved dialysis practices, and needle exchange programs.

It also acknowledged a 2019 study that found 57.9% of estimated births to women who test positive for the hepatitis B surface antigen were attributable to non–US-born women, mainly from high-endemicity countries. The study reported that 0.5% of pregnancies in the US are to women who test positive for the hepatitis B surface antigen, which is the most significant risk to newborns for being infected with the virus.

ACIP Childhood/Adolescent Schedule Workgroup Chair Vicky Pebsworth, PhD, RN, additionally presented the policy context and historical and international comparison of the immunization schedule for hepatitis B, determining the United States' universal recommendation of the hepatitis B vaccine birth dose is an outlier among developed countries with low hepatitis B prevalence.

“The meeting lacked transparency, with many of the presentations showing one-sided data, and several points made by Committee members clearly showed that they have a very specific agenda,” the Hepatitis B Foundation wrote in a statement.

 “The hepatitis B vaccine birth dose has proven to be among our most effective tools for protecting infants from a preventable, cancer-causing disease. The committee members dismissed the extensive body of scientific data and real-life experience that prove the necessity, safety and value of the universal birth dose vaccine for hepatitis B.”

As described in the December 5, 2025, release from the CDC, a recommendation from ACIP becomes part of the CDC immunization schedule once it is adopted by the CDC director.

CDC. ACIP Recommends Individual-Based Decision-Making for Hepatitis B Vaccine for Infants Born to Women Who Test Negative for the Virus. December 5, 2025. Accessed December 5, 2025. 

https://www.cdc.gov/media/releases/2025/2025-acip-recommends-individual-based-decision-making-for-hepatitis-b-vaccine-for-infants-born-to-women.html

CDC. Hepatitis B Perinatal Vaccine Information. August 27, 2025. Accessed December 5, 2025. 

https://www.cdc.gov/hepatitis-b/hcp/perinatal-provider-overview/vaccine-administration.html

Hepatitis B Foundation. Hepatitis B Foundation responds to ACIP discussion on Dec. 4, 2025. December 4, 2025. Accessed December 5, 2025. 

https://www.hepb.org/news-and-events/news-2/hepatitis-b-foundation-responds-to-acip-discussion-on-dec-4-2025/

The CDC's ACIP has recommended an individual-based approach for hepatitis B vaccination in infants born to women testing negative for the virus. This marks a shift from the previous universal birth dose recommendation. The initial dose is suggested no earlier than two months if not given at birth. The decision follows discussions on hepatitis B disease burden, vaccine safety, and international immunization policies. The Hepatitis B Foundation criticized the meeting for lacking transparency and dismissing evidence supporting the universal birth dose. The recommendation awaits adoption by the CDC director.

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

CDC Changes Infant Hepatitis B Vaccine Recommendation

Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

New findings highlight low serum albumin levels as a predictor of increased risk of cancer and subsequent mortality in patients undergoing 

“The results demonstrated the inverse association of serum albumin levels with cancer risk and overall mortality after cancer diagnosis in patients undergoing maintenance HD,” wrote study investigator Seok Hui Kang, MD, PhD, an associate professor and academic researcher at Yeungnam University, and colleagues. “They support the value of regular monitoring of serum albumin as part of a comprehensive patient assessment in patients undergoing HD.”

Cancer incidence and cancer-specific mortality are elevated among patients with end-stage kidney disease (ESKD) compared with the general population. Although prior studies have examined cancer risk in patients with ESKD undergoing hemodialysis, the association between serum albumin levels and cancer risk in this population remains unclear.

To address this gap in research, Kang and colleagues analyzed HD quality assessment program data from the Korean Health Insurance Review and Assessment Service. The primary exposure of interest was serum albumin level (g/dL), measured as part of routine laboratory testing.

Investigators collected monthly data on hemoglobin levels, body mass index, Kt/Vurea, serum phosphorus levels, serum creatinine levels, and ultrafiltration volume. The incidence of any cancer was defined as the presence of ICD-10 codes for 12 cancers between the endpoint and follow-up. Survival duration was calculated as time between diagnosis of any cancer and time of death or censoring.

The retrospective cohort study included 64,728 adult patients ≥ 18 years of age undergoing maintenance HD for ≥3 months and ≥2 times per week. Investigators stratified patients into quintiles based on their serum albumin levels: 1Q (3.12–3.72 g/dL), 2Q (3.73–3.92 g/dL), 3Q (3.93–4.06 g/dL), 4Q (4.07–4.21 g/dL), and 5Q (4.25–4.73 g/dL).

Since baseline characteristics were significantly different between each quintile, investigators used propensity score weighting to balance them using generalized boosted models for patient demographics, comorbidities, dialysis parameters, labs, medications, and cardiovascular history. After characteristic balancing, follow-up, and cancer-free and post-diagnosis patient survival rates were broadly similar across quintiles.

From the results of the univariable and multivariable Cox regression analyses, investigators observed increased risks of cancer in the 1Q and 2Q groups compared to the 3Q group (adjusted HR [aHR], 1.12; 95% CI, 1.08–1.16 for 1Q vs 3Q; aHR, 1.08; 95% CI, 1.04–1.12 for 2Q vs. 3Q). Accordingly, the 4Q group had a decreased risk of cancer than the 3Q group (aHR, 0.94; 95% CI, 0.91–0.98). Regarding all-cause mortality among patients with cancer, the 1Q group had an increased risk of all-cause mortality than the 3Q group (aHR, 1.16; 95% CI, 1.11–1.22).

Investigators conducted subgroup analyses by age (≥60 years) and sex. In multivariable models, they discerned an association with decreased serum albumin levels and an increased risk of cancer and subsequent all-cause mortality across both subgroups, with a pronounced association among patients <60 years and among women. In male participants, increased serum albumin levels were linked to a decreased risk of all-cause mortality after a cancer diagnosis. Conversely, in female participants, increased albumin levels were associated with an increased risk of all-cause mortality.¹

In a subgroup analyses of cancer types, the association between decreased albumin levels and cancer risk was strongest for gallbladder or bile duct cancer (aHR, 1.54; 95% CI, 1.27–1.87 for 1Q vs. 3Q) and for uterine or cervical cancer (aHR, 1.64; 95% CI, 1.34–2.00 for 1Q vs. 3Q). Generally, increased albumin levels (4Q–5Q) were associated with decreased risks of cancer. Investigators noted this was not uniform across all cancer types. For example, patients in the highest quintile (5Q) demonstrated a significantly increased risk of prostate, gallbladder, bile duct, uterine, cervical, and bladder cancers.

After a cancer diagnosis, Kang and colleagues noted that decreased albumin levels were associated with increased risks of all-cause mortality in most types. However, in thyroid, breast, and liver cancers, the uppermost serum albumin group (5Q) was associated with an increased risk of mortality. From these findings, investigators deduced that baseline serum albumin levels may not be uniformly associated with increased survival across all types of cancers.

“Although we demonstrated an association between serum albumin levels and cancer incidence, this relationship was only modest and may be influenced by numerous confounding factors,” investigators concluded.”Therefore, it is difficult to recommend any modification of cancer screening strategies based solely on our findings. Such recommendations would require a thorough analysis of diagnostic performance metrics, including sensitivity and specificity.”

Kim M, Park SY, Lim YJ, et al. Low serum albumin levels as a predictor of increased risk of cancer in patients undergoing maintenance hemodialysis. 

. Published online December 4, 2025. doi:

Taborelli M, Toffolutti F, Del Zotto S, et al. Increased cancer risk in patients undergoing dialysis: a population-based cohort study in North-Eastern Italy. 

https://doi.org/10.1186/s12882-019-1283-4

Low serum albumin levels have been identified as a predictor of increased cancer risk and mortality in patients undergoing maintenance hemodialysis. A study analyzed data from the Korean Health Insurance Review and Assessment Service, involving 64,728 adult patients. Results showed that lower serum albumin levels were associated with higher cancer risk and mortality, particularly in younger patients and women. The study highlighted the need for regular monitoring of serum albumin levels but cautioned against modifying cancer screening strategies based solely on these findings due to potential confounding factors.

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


Nephrology

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

Chronic Kidney Disease

Serum Albumin Levels Can Predict Increased Cancer Risk in Hemodialysis

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

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

Evolving Evidence Supporting Remote Patient Monitoring in Cardiology

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


Dementia and Alzheimer Disease

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

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

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

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

More Costly, Polarized Dermatoscope Results Compared to Nonpolarized Dermatoscope

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


Video Series

Mechanistic Roles of Transthyretin Silencers and Stabilizers in ATTR-CM

Next-generation TIC-2 inhibitors show remarkable selectivity, enhancing efficacy while minimizing side effects, offering insights into immune system safety.

Selectivity of TYK2 Inhibition in Psoriasis

In this episode, the panelists focus on the IL-23 and IL-17 pathways and their influence on inflammation control and psoriatic arthritis (PsA) prevention. The experts explain that IL-23 sits at the top of the inflammatory cascade, driving Th17 cell activation and downstream cytokine release. They note that inhibiting IL-23 can lead to long-term immunologic remission and possibly modify PsA progression, given its infrequent dosing and favorable safety profile. The discussion compares IL-23 and IL-17 inhibition, highlighting that while IL-23 blockade targets disease upstream, IL-17 acts as the “enforcer” cytokine driving local joint and skin inflammation. The panelists review emerging data showing that dual inhibition of IL-17A and IL-17F, as achieved with newer biologics, may provide more robust and durable skin clearance than targeting IL-17A alone. They conclude that deeper inflammation control through these pathways could reduce PsA risk and sustain long-term disease remission.

Targeting IL-23 and IL-17 in Psoriatic Disease: Pathways to Inflammation Control and PsA Prevention

The panel shifts to remaining unmet needs in ATTR-CM care, emphasizing that despite progress in diagnosis and available therapies, gaps persist across patient identification, treatment access, and long-term management. One ongoing challenge is recognizing early disease and distinguishing ATTR-CM from other common cardiac conditions, particularly in older adults with preserved ejection fraction. The experts stress that clinicians must think beyond labeling HFpEF as a final diagnosis by seeking its underlying cause.
Therapeutically, the group notes that while stabilizers and silencers have expanded treatment options, navigating these therapies requires careful consideration of patient characteristics, tolerance, and evolving evidence. Cost and access barriers continue to affect who receives treatment and when. The panel also highlights the need for more data on disease monitoring and response assessment, particularly regarding biomarkers and imaging changes over time. Finally, greater patient and provider education, coordinated care pathways, and earlier referrals remain essential to improving outcomes.


Unmet Needs in ATTR-CM Care

As mental health AI tools rise, the FDA weighs benefits and risks, emphasizing oversight and performance testing. Eriksson discusses AI in psychiatric care.

FDA Examines Generative AI in Psychiatry, With Hans Eriksson, MD, PhD

Explore the distinct role of TIC-2 in psoriasis and how selective inhibition offers targeted treatment advantages over traditional JAK inhibitors.

Therapeutic Potential of TYK2 Inhibition in Psoriasis

In this discussion, the panelists examine current evidence supporting early systemic treatment in psoriasis to help prevent psoriatic arthritis (PsA). The experts reference retrospective and observational studies suggesting that biologic therapies—particularly IL-17 and IL-23 inhibitors—may reduce the incidence of PsA development among patients with psoriasis. While acknowledging limitations in available data, such as the lack of prospective randomized trials, the panelists agree that existing evidence is meaningful and should inform proactive management. They stress that early initiation of systemic therapy can address the shared inflammatory pathways of skin and joint disease, potentially modifying disease progression before irreversible joint damage occurs. The experts highlight the importance of shifting from reactive to preventive care, emphasizing that treating psoriasis systemically and earlier in its course could close the current gap between achieving complete skin clearance and preventing long-term musculoskeletal complications.

Latest News

5 FDA Headlines You Missed in November 2025

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

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

CDC Changes Infant Hepatitis B Vaccine Recommendation

Serum Albumin Levels Can Predict Increased Cancer Risk in Hemodialysis