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FDA News|

The Respiratory Report

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## Conference Coverage

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about 1 hour ago

Lebrikizumab Benefits AD Patients With Skin of Color, With Vinay Mehta, MD

about 2 hours ago

Early Treatment May Protect Cognitive Function in Wilson Disease, With Michael Schilsky, MD

about 5 hours ago

aha

Atrial Fibrillation in Peripheral Arterial Disease Increases MACE Risk, with Viet Le, DMSc, PA-C

1 day ago

aha

AHA 2025 Conference Recap: 4 Late-Breaking Trials to Know

2 days ago

Discussing New Topical Drugs for Atopic Dermatitis in Younger Patients, With Peter Lio, MD

3 days ago

aha

Broadening Access to Cardiovascular Care for Female Patients, With Emily Lau, MD

3 days ago

acr

ACR Convergence 2025 Recap: Late-Breaking Trials to Know

3 days ago

gold

Breaking Down the 2026 GOLD Report, with Claus Vogelmeier, MD

3 days ago

Top Trial Recaps from ACAAI 2025

3 days ago

Discussing Zasocitinib and Other TYK2 Inhibitors for Psoriasis, With Ronald Vender, MD

## Trending on HCPLive

1

### FDA Accepts sNDA for Roflumilast Cream 0.3% in Children Ages 2 to 5 with Psoriasis

2

### AHA 2025 Conference Recap: 4 Late-Breaking Trials to Know

3

### Discussing New Topical Drugs for Atopic Dermatitis in Younger Patients, With Peter Lio, MD

4

### Tralokinumab Improves Atopic Dermatitis with Hand Involvement at 32 Weeks

5

### Escalating Therapy in Chronic Spontaneous Urticaria Management

# Latest News

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Nov 17, 2025News

### Tralokinumab Improves Atopic Dermatitis with Hand Involvement at 32 Weeks

Tim Smith

#### FDA Accepts sNDA for Roflumilast Cream 0.3% in Children Ages 2 to 5 with Psoriasis

Tim Smith

#### AHA 2025 Conference Recap: 4 Late-Breaking Trials to Know

Ryan Livingston

#### ACR Convergence 2025 Recap: Late-Breaking Trials to Know

Victoria Johnson

#### FDA Issues New Boxed Warning, Limiting ELEVIDYS to Ambulatory DMD

Alex Hillenbrand

Previous slideNext slide

##### Current Standard of Care and Treatment Options in Psoriasis

##### Cytokine Pathways and Their Impact on Plaque Psoriasis

##### Lebrikizumab Benefits AD Patients With Skin of Color, With Vinay Mehta, MD

##### Early Treatment May Protect Cognitive Function in Wilson Disease, With Michael Schilsky, MD

##### Atrial Fibrillation in Peripheral Arterial Disease Increases MACE Risk, with Viet Le, DMSc, PA-C

##### Escalating Therapy in Chronic Spontaneous Urticaria Management

##### Emerging Therapies in Psoriasis and the Role of Biomarkers in Precision-Based Care

##### Recognizing and Assessing Disease Burden in Chronic Spontaneous Urticaria

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## Shorts

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0:55

1 Year Data Proves Power of IL-17i for PsA

a day ago

by

Philip J. Mease, MD

0:58

Achieving State Zero in Psoriatic Arthritis

2 days ago

by

Philip J. Mease, MD

0:59

Dupilumab Cuts Surgery Need in Patients with Allergic Fungal Rhinosinusitis

3 days ago

by

Amber Luong, MD, PhD

2:14

The Puzzle of Polypill Adherence

3 days ago

by

Muthiah Vaduganathan, MD, MPH(+2 more)

1:04

How to Differentiate Other Forms of Arthritis and Psoriatic Arthritis

3 days ago

by

Shikha Singla, MD

1:18

Kidney Week: DUPLEX Supports Safety of Sparsentan in Pediatric FSGS

4 days ago

by

Michelle Rheault, MD

1:08

Why Enlicitide Will Revolutionize Primary Care Prescribing

8 days ago

by

Ann Marie Navar, MD, PhD

0:46

Key Members of a Multidisciplinary Team in Heart Failure Care

11 days ago

by

David Landers, MD

1:03

AI Scribes Cut Doctor Burnout Within 30 Days

17 days ago

by

Lee Schwamm, MD

1:04

Simplifying Oral Semaglutide for Everyday Use

18 days ago

by

Diana Isaacs, PharmD, BCPS, BCACP, BC-ADM, CDCES(+1 more)

Previous slideNext slide

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## Podcasts

View More

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

Cohosts Stephen Greene, MD, and Muthiah Vaduganathan, MD, sat down with Ambarish Pandey, MD, to discuss the revolutionary POLY-HF trial and how polypills can fit into heart failure treatment.

Nov 14, 2025

### Kidney Compass: Understanding Renal Outcomes in SURPASS-CVOT

Discover groundbreaking insights from ASN Kidney Week on the SURPASS-CVOT trial.

Nov 13, 2025

### Kidney Compass: Setanaxib, Alport Syndrome, and RaDaR Updates at Kidney Week 2025

Neuen and Gale break down groundbreaking insights on Alport syndrome and glomerular diseases, including RaDaR registry data.

Nov 8, 2025

### Kidney Compass: Obinutuzumab, REGENCY, & Updates in Lupus Nephritis, With Brad Rovin, MD

Discover groundbreaking insights on lupus nephritis treatment from the REGENCY trial, highlighting the impact of obintuzumab on patient outcomes.

Nov 8, 2025

### Diabetes Dialogue: FINE-ONE and Finerenone in Type 1 Diabetes at Kidney Week 2025

Discover groundbreaking findings from the FINE-ONE trial on finerenone, offering hope for type 1 diabetes patients with CKD.

Nov 8, 2025

### Kidney Compass: SMART-C at ASN Kidney Week 2025

Discover groundbreaking insights on SGLT2 inhibitors and their impact on kidney health, cardiovascular outcomes, and patient care at ASN Kidney Week.

Nov 8, 2025

### Kidney Compass: Atacicept and ORIGIN 3 at Kidney Week 2025, with Richard Lafayette, MD

Discover groundbreaking insights from the ORIGIN 3 study on IgA nephropathy, showcasing promising results and future treatment possibilities.

Nov 6, 2025

### Diabetes Dialogue: Oral Semaglutide and SELECT at DTM 2025

This episode covers the recent approval of oral semaglutide for T2D and a pre-specified subanalysis of the SELECT trial.

Oct 29, 2025

### Liver Lineup: Unmet Needs and Evolving Standards in Alcohol-Associated Liver Disease, With Jessica Mellinger, MD

Mellinger joins Liver Lineup to discuss current shortcomings in ALD diagnosis and care, the importance of addressing underlying alcohol use disorder, and more.

Oct 14, 2025

### Diabetes Dialogue: Biolinq Shine, Insulin Icodec, and Eli Lilly's Pipeline

This episode covers the upcoming glucose monitor Biolinq Shine, the Insulin Icodec FDA resubmission, and the end of Eli Lilly's work in T2D.

Oct 14, 2025

Previous slideNext slide

* * *

## Videos

View More

Previous slideNext slide

##### Reforming Trial Designs to Better Address Unmet Needs in Psoriasis Care

##### Discussing New Topical Drugs for Atopic Dermatitis in Younger Patients, With Peter Lio, MD

##### Broadening Access to Cardiovascular Care for Female Patients, With Emily Lau, MD

##### Breaking Down the 2026 GOLD Report, with Claus Vogelmeier, MD

##### Discussing Zasocitinib and Other TYK2 Inhibitors for Psoriasis, With Ronald Vender, MD

##### The Practical Hurdles in COPD Detection, with Francesca Polverino, MD, PhD

##### Progress with Emerging TYK2 Inhibitors for Psoriasis, With Benjamin Lockshin, MD

##### Expert Perspectives on Oral Treatment Research Needs for the Future

* * *

## Continuing Medical Education

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Video

## Clinical Consultations™: Addressing Elevated Phosphate Levels in Patients with END-STAGE Kidney Disease (ESKD)

Anil K. Agarwal, MD, FACP, FASN, FNKF, FASDIN; Jay B. Wish, MD

View more

Multimedia

## Advances In: Managing Hyperphosphatemia in Chronic Kidney Disease – Bridging Treatment Gaps With Novel Therapies

Glenn M. Chertow, MD, MPH; Anjay Rastogi, MD, PhD

View more

Case-based Simulation

## SimulatED™: Understanding the Role of Genetic Testing in Patient Selection for Anti-Amyloid Therapy

Nicholas Doher, DO; Babak Tousi, MD

View more

Multimedia

## Burst CME™: Addressing Inadequate Response to Anti-TNF Therapy in Patients With Rheumatoid Arthritis

Jeffrey A. Sparks, MD, MMSc

View more

Multimedia

## Community Practice Connections™: Cases and Conversations – Keeping Up with Novel Approaches to Managing ANCA-Associated Vasculitis

Frank B. Cortazar, MD; Lindsay S. Lally, MD

View more

Video

## Burst CME: Targeted Therapy for Optimal Psoriasis Management

Tina Bhutani, MD

View more

Video

## Cases and Conversations™: A Horizon View of Continuous Monitoring Systems for Diabetes Management

Diana Isaacs, PharmD, BCPS, BC-ADM, BCACP, CDCES, FADCES, FCCP; Anders Carlson, MD; Jennifer B. Green, MD

View more

Video

## Progress in Hyperlipidemia Management to Reduce ASCVD Risk: An Illustrated Update

Nihar R. Desai, MD, MPH; Martha Gulati, MD, MS, FACC, FAHA, MASPC, FESC, FSCCT (hon), FRCP Edin

View more

Previous slideNext slide

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## All News

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Advertisement

### Top Trial Recaps from ACAAI 2025

ByChelsie Derman

November 14th 2025

Here, we spotlighted 4 late-breaker studies featured in our ACAAI 2025 coverage, along with 2 phase 3 trials.

### Povorcitinib Improves Itch, Hive CSU Symptoms Within 3 Days, With Weilly Soong, MD

ByChelsie Derman

November 14th 2025

In this Q&A, Soong discusses phase 2 results on povorcitinib, a JAK1 inhibitor that provides rapid relief from chronic spontaneous urticaria symptoms.

### ATTRibute-CM: Acoramidis Lowers Mortality in Patients With Amyloid Cardiomyopathy

ByRyan Livingston

November 14th 2025

Acoramidis also increased serum transthyretin in patients with wild-type ATTR-CM or the pathogenic variant ATTRv-CM.

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

ByChelsie Derman

November 14th 2025

FDA clears BrainsWay's Deep TMS for adolescents aged 15-21 years with major depressive disorder (MDD), expanding its use.

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

ByMuthiah Vaduganathan, MD, MPH,Stephen J. Greene, MD, FACC, FHFSA,Ambarish Pandey, MD

November 14th 2025

Cohosts Stephen Greene, MD, and Muthiah Vaduganathan, MD, sat down with Ambarish Pandey, MD, to discuss the revolutionary POLY-HF trial and how polypills can fit into heart failure treatment.

### IMPACT: Pemvidutide for MASH Resolution and Weight Loss, With Mazen Noureddin, MD, MHSc

ByMazen Noureddin, MD, MHSc

November 13th 2025

Noureddin explains 24-week data showing significant MASH resolution, weight loss, and evidence of anti-fibrotic activity with the GLP-1/glucagon dual receptor agonist.

### Defining Elafibranor’s Role in a New Era of PBC Management, With Cynthia Levy, MD

ByCynthia Levy, MD

November 13th 2025

Levy explains elafibranor’s role in the PBC 2LT treatment landscape and new long-term ELATIVE open-label extension data presented at AASLD 2025.

### ECRIs Potential for Long-Term Disease Modification in CSU, With Geoff Harris, PhD

ByGeoff Harris, PhD

November 13th 2025

At ACAAI 2025, Harris spoke with HCPLive about Excellergy’s ECRI program, exploring IgE modulation, safety goals, and potential long-term effects in CSU.

### Kidney Compass: Understanding Renal Outcomes in SURPASS-CVOT

ByBrendon Neuen, MD

November 13th 2025

Discover groundbreaking insights from ASN Kidney Week on the SURPASS-CVOT trial.

### Essentials for Early Career Success Among Dermatology PAs, With Joseph Gatti, DMSc, MPAS, MBA, PA-C

ByJoseph Gatti, DMSc, MPAS, MBA, PA-C

November 12th 2025

This discussion at the SDPA Fall Conference highlights some scheduling and contract essentials for early career success among physician associates (PAs).

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### Personalized COPD Treatment: Lessons from Biologic Trials and Clinical Practice

ByVictoria Johnson

November 12th 2025

COPD management evolves with targeted biologic therapies, enhancing treatment precision and improving patient outcomes in respiratory care.

### Long-Term Elafibranor Treatment Leads to Biochemical, Symptomatic Improvements in PBC

ByAlex Hillenbrand

November 11th 2025

ELATIVE 3-year open-label extension data show sustained reductions in pruritus and fatigue in adults with primary biliary cholangitis treated with elafibranor.

### Target-D: Optimized Vitamin D Dosage Reduces Risk of Myocardial Infarction in Heart Disease Patients

ByRyan Livingston

November 10th 2025

Although the initial MACE composite outcome was not statistically significant, investigators saw follow-up MI risk reduced by >50%.

### Seladelpar’s Impact on Liver Stiffness Measurements in PBC, With Christopher Bowlus, MD

ByChristopher Bowlus, MD

November 10th 2025

Bowlus explains clinical outcomes associated with PBC and the importance of assessing liver stiffness over time, highlighting data on seladelpar from AASLD.

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

ByRyan Livingston

November 10th 2025

The SGLT2 inhibitor also displayed its efficacy in reducing left ventricular myocardial fibrosis and volume, as well as improving diastolic filling dynamics.

### Real-World Data Reveal High Rates of Trientine Tetrahydrochloride Adherence for Wilson Disease

ByAbigail Brooks, MA

November 10th 2025

The analysis of data from a single-source rare disease specialty pharmacy sheds light on high treatment adherence and low discontinuation of Cuvrior.

### Uptrend in Acute Kidney Injury Mortality in Higher Socioeconomic Countries Projected to Continue

ByVictoria Johnson

November 10th 2025

Acute kidney injury mortality rises in wealthier nations, highlighting urgent need for targeted prevention strategies.

### VCTE’s Potential for Monitoring AATD Liver Disease, With Virginia Clark, MD

ByVirginia Clark, MD

November 10th 2025

Clark reviews findings from a 3-year longitudinal study comparing VCTE to liver biopsy for staging F2/F3 fibrosis in patients with AATD liver disease.

### Mazdutide Significantly Reduces Liver Fat, Improves Metabolic Markers in MASLD, Obesity

ByAlex Hillenbrand

November 9th 2025

AASLD 2025 data show mazdutide significantly reduces liver fat, ALT, AST, and insulin resistance in patients with obesity, and MASLD

### DECAF: Caffeine Consumption Does Not Increase, May Improve Atrial Fibrillation Risk

ByRyan Livingston

November 9th 2025

Data from the DECAF study suggests caffeine may have a slightly beneficial effect on AF recurrence, although investigators urge caution in interpretation.

### Elafibranor Benefits Fatigue-Related Pathways Linked to Mitochondrial Function in PBC

ByAbigail Brooks, MA

November 9th 2025

Findings showed elafibranor led to expression changes of proteins linked to fatigue or mitochondrial function, significantly correlated with each other and with fatigue improvement.

### Seladelpar’s Role in the Post-Obeticholic Acid PBC Treatment Landscape, With Christopher Bowlus, MD

ByChristopher Bowlus, MD

November 9th 2025

Bowlus explains seladelpar’s role in PBC care, including for patients transitioning from obeticholic acid, based on real-world data.

### Regeneron’s Factor XI Antibodies Prevent Thromboembolism After Knee Replacement

ByRyan Livingston

November 9th 2025

REGN7508 and REGN9933 displayed their efficacy in preventing deep venous thromboembolism in patients undergoing knee replacement surgery in 2 phase 2 clinical trials.

### Sibeprenlimab Safely Reduces Gd-IgA1, Other IgAN Markers, in New Analysis

ByVictoria Johnson

November 9th 2025

Sibeprenlimab shows promising results in reducing proteinuria and improving kidney health in IgA nephropathy.

### Younger Age at Glomerular Disease Diagnosis Linked to Greater Lifetime Risk Despite Similar Progression Rates

ByVictoria Johnson

November 9th 2025

A recent study reveals that younger patients with glomerular disease face a higher lifetime risk of kidney failure despite similar progression rates.

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