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 

Antibiotic use is linked with an increased risk of biologic drug discontinuation for 

, new data suggest, though a causal link between antibiotics and diminished biologic durability remains undiscovered.

These data were authored by investigators such as Raphaël Ouakrat, MD, from Université Paris-Est Créteil (UPEC) in France, all of whom set out to explore the impact of antibiotic utilization among patients with psoriasis on biologic treatment use. Prior to their study, the investigative team noted the potential of antibiotic use in patients with psoriasis to impact outcomes due to such drug interactions or immunologic impacts.

Additionally, the team highlighted the proposition suggesting gut dysbiosis may serve as a modifying factor for psoriasis therapy efficacy.

 Such prior data impacted their decision to pursue this subject.

“The aim of this study was to evaluate the association between oral antibiotic exposure and the persistence of biologic therapies in psoriasis,” Ouakrat and colleagues wrote.

Ouakrat and coauthors collected the necessary data from the French National Health Insurance database in this analysis. They also implemented a validated approach within the Système National des Données de Santé to identify patients living with psoriasis. In this process, the investigators selected a set of individuals who had been given at least 2 dispensations of topical vitamin D derivatives within a 2-year timeframe; in this method, there is a reported sensitivity of 84.5% and a specificity approaching 100%.

Among those included in this group, the investigative team would assess adults who subsequently were provided with at least a single biologic medication in the period between January 2012 - June 2022, following the second vitamin D dispensation. The index data would be the date of the first biologic prescription. Only those who were initiating biologic drugs who also had no biologic use in the preceding 12 months were deemed eligible by the team.

Ouakrat et al assessed the use of systemic antibiotics both at the point of baseline and throughout follow-up as a time-dependent variable. They categorized baseline exposure based on subjects' number of antibiotic dispensations in the 6 months before the study's index date and, during follow-up, this variable was continuously updated to reflect participants' level of antibiotic exposure within the previous half-year through the same categories.

The investigative team's main outcome was determined to be whether patients discontinued or switched their first biologic drug course. The team incorporated antibiotic exposure in the 6 months preceding initiation of biologic use and during follow-up into a weighted Cox marginal structural model for the purposes of generating adjusted hazard ratios. There were 36,129 individuals included as participants.

The team noted 42.0% of those involved in the analysis were women and 55.9% were men. These individuals had a mean age of 48.4 years. The investigators determined, at baseline, 25.9% of these subjects had been given an antibiotics prescription and 60.6% were provided with antibiotics at some point over the course of follow-up.

 Macrolides, β-lactams, and fluoroquinolones were noted to have been the antibiotic classes implemented by patients most frequently.

A link was found between exposure to antibiotics and an increase in participants' likelihood of stopping or switching biologic treatments, with a weighted hazard ratio of 1.12 (95% CI, 1.08–1.16).

 This association was shown by Ouakrat and coauthors to be more pronounced among those with multiple dispensations, whose weighted hazard ratio was 1.29 (95% CI, 1.24–1.35), suggesting a potential dose-response pattern.

Overall, the investigators noted a significant relationship was observed between antibiotic utilization and reduced persistence of biologic drugs in psoriasis. These data were described as consistent with the concept that antibiotics, potentially resulting from gut microbiome disruption, may negatively impact the durability of biologics. Nevertheless, the team noted residual confounding cannot be ruled out. They further pointed to the need for additional research to confirm such findings, suggesting a more favorable disease course than previously highlighted.

“While causality is unproven, minimizing unnecessary antibiotic exposure may support better treatment persistence,” the investigators concluded.

 “Further research is warranted to confirm these associations, clarify underlying mechanisms, and identify patient-related and treatment-related factors influencing biologic durability.”

Ouakrat R, Penso L, Sbidian E, et al. Antibiotic Use and the Persistence of Biologic Therapies in Patients With Psoriasis. JAMA Dermatol. Published online November 12, 2025. 

Gorelik Y﻿, Freilich S﻿, Gerassy-Vainberg S﻿, et al; IIRN. Antibiotic use differentially affects the risk of anti-drug antibody formation during anti-TNFα therapy in inflammatory bowel disease patients: a report from the epi-IIRN. Gut. 2022;71(2):287-295. doi:10.1136/gutjnl-2021-325185.

Articles

New data suggest a link between antibiotic use and increased risk of biologic drug discontinuation in psoriasis patients, though causality remains unproven. The study, conducted by researchers from Université Paris-Est Créteil, utilized the French National Health Insurance database to assess the impact of antibiotics on biologic therapy persistence. Findings indicate a significant association between antibiotic exposure and reduced biologic durability, potentially due to gut microbiome disruption. The study emphasizes the need for further research to confirm these associations and explore underlying mechanisms affecting biologic treatment persistence.

In this analysis, investigators explored potential impacts of antibiotic exposure on the persistence of biologic treatments in patients living with psoriasis.

Dermatology

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

Plaque Psoriasis

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

News

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Antibiotic Exposure Linked to Increased Risk of Biologic Discontinuation in Psoriasis

Barr discusses the means to encourage systemic adoption of low dose CT scans to help curb the deadliest cancer in the US.

Bettering CT Scan Rates in Pulmonology, with Graham Barr, MD, DrPH

Despite there being highly determinable clinical and behavioral risk factors, access to Medicare-covered screening measures, and a severe mortality risk in cases diagnosed too late, the frequency of 

 screening remains precipitously low among eligible patients in the US.

The matter of improving this recurring trend — as has been previously discussed by experts — requires behavioral shifts from clinicians in the position to seek out a diagnosis.

Chronic Obstructive Lung Disease (GOLD) International COPD Conference

 in Philadelphia, PA, Graham Barr, MD, DrPH, Chief of the Division of General Medicine at NewYork-Presbyterian and Columbia University Irving Medical Center, discussed the continually minimal use of low dose computed tomography (CT) scans on patients at determined risk of lung cancer.

As Barr emphasized, low dose CT scan is not some novel, unevidenced diagnostic tool — is it covered by Medicare and private insurers and is recommended for use in eligible patients based on criteria factors by the United States Preventive Services Task Force (USPSTF). Despite it being available and endorse like any standard screening tool, only about one-fourth (28.1%) of US patients are diagnosed at an early lung cancer state during which they experience a 65% five-year survival rate. US patients are primarily diagnosed (43%) in late-stage lung cancer, when survival rate is approximately 10%.

From Barr’s perspective, the common reasons why a colleague may not prescribe a primary cancer test do not apply to low dose CT scans: it is neither costly like a full pulmonary function test, nor is it linked to a high risk of adverse events like initially believed.

“It's a dramatically underused test and it's sort of staggering that we're still in this position,” Barr said. “It would not be acceptable if we were talking about breast cancer screening, if we were talking about pap smear screening, and so forth. We have to straighten this out.”

Barr disagreed with the theory that patient follow-through on screening referrals have a major impact on the utility of low dose CT scans. Instead, he said systems have been slow to adopt it as standard practice and clinicians are still struggling with the stigma tied with smoking.

“We still have a habit of saying, ‘Somebody got into this trouble by smoking’,” Barr said. “But whether or not they have quit [the habit], they’re still eligible [for screening] in the most part, and we should be pushing it aggressively.”

As Barr looks at the checklist of hurdles his colleagues must still clear to streamline low dose CT scans in pulmonology practices, he highlights “evidence.” There are mortality reduction-based data supporting the tool but even more robust randomized clinical trial data showing the benefit of timely lung cancer screening in the continuum of care for eligible patients. Healthcare systems can play their role by implementing quality control programs to assess their own outcomes and refine their internal processes to both clinician and patient satisfaction.

More supporting data, and a system tailored to their practice and patients, may help to overcome the stigmas surrounding both lung cancer and low dose CT scans.

“There’s not an inherent resistance to mammography screening, colon cancer screening…there’s really no reason we shouldn’t get this done,” Barr said.

Wood D, Kunzmann K. What Ails Lung Cancer Screening, with Douglas Wood, MD. 

. Published October 20, 2025. https://www.hcplive.com/view/what-ails-lung-cancer-screening-douglas-wood-md

American Lung Association. State of Lung Cancer 2025: Lung Cancer Key Findings. Web page. Last updated November 3, 2025. https://www.lung.org/research/state-of-lung-cancer/key-findings

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Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

Lung Cancer

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.

November witnessed dynamic activity in the nephrology landscape. From coverage at the 

American Society of Nephrology (ASN) Kidney Week 2025

has captured the most important developments shaping kidney care this month.

Highlights from this month showcase the rapid evolution of kidney therapeutics and clinical management. In IgAN, emerging immune-targeted therapies, including sibeprenlimab, telitacicept, atacicept, and others, are demonstrating meaningful reductions in proteinuria, improvements in pathogenic biomarkers, and signs of disease-modifying potential for patients at risk of progression. Advances in 

focal segmental glomerulosclerosis (FSGS)

 and membranous nephropathy further reinforce the potential of agents such as sparsentan and MIL62 to improve remission rates and long-term kidney outcomes.

Progress in kidney transplantation and immunosuppression, from safer rejection prevention with tegoprubart to supportive data on post-transplant pregnancies, offers actionable insights for clinicians managing complex cases. Developments across 

), dialysis, and rare kidney disorders, including new FDA orphan designations and late-stage trial readouts, continue to expand the therapeutic landscape and inform evidence-based care.

Check out this November 2025 nephrology month in review for a recap of 

’s coverage of the top renal news and research from the past few weeks:

FDA Awards Accelerated Approval to Sibeprenlimab in IgA Nephropathy

The FDA awarded accelerated approval to sibeprenlimab (Voyxact), a targeted APRIL inhibitor, for adults with IgAN at risk for disease progression. The phase 3 VISIONARY trial showed promising safety, a 54.3% reduction in proteinuria, 

galactose-deficient immunoglobulin A1 (Gd-IgA1)

, and other disease biomarkers, offering a new option for patients at risk of progressive kidney disease.

Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study

The B-cell modulating biologic telitacicept met its primary endpoint in a multicenter, double-blind phase 3 study. Investigators reported a -58.9% change in 24-hour urine protein-to-creatinine ratio (24h-UPCR) versus -8.8% for placebo (

 <.0001), alongside a favorable safety profile, supporting its potential as a disease-modifying therapy in high-risk IgAN patients.

Understanding Atacicept & 36-Week ORIGIN 3 Data from Kidney Week 2025, With Jonathan Barratt, MBChB, PhD

Interim results from the ORIGIN-3 trial, presented at ASN Kidney Week 2025, showed that dual BAFF/APRIL inhibitor atacicept led to a 68.3% decrease in Gd-IgA1, resolution of dipstick hematuria in 81.0% of patients, and a 47.3% reduction in urinary albumin-to-creatinine ratio. Jonathan Barratt, MBChB, PhD, outlines atacicept’s role in the evolving IgAN pathway below.

PROTECT: Sparsentan Offers CV Protection Benefits as First-Line Therapy in IgAN

A 24-week analysis from the SPARTAN study suggests sparsentan (Filspari), a dual endothelin and angiotensin receptor antagonist, produces rapid proteinuria reductions (~70%) alongside favorable trends in blood pressure, cardiac structure, and cardiovascular biomarkers, supporting its use as first-line therapy in adults with IgAN.

 showed sparsentan achieved earlier and more frequent reductions in proteinuria (UPCR <0.7 g/g) and improved long-term kidney outcomes compared with irbesartan in patients with focal segmental glomerulosclerosis (FSGS).

MIL62 Shows Increased Remission and Reduced Relapse Versus Cyclosporine A in MN

In adults with primary membranous nephropathy (MN), MIL62 achieved complete remission in 49.4% of patients by week 76 versus 3.9% with cyclosporine A. Overall remission rates were consistently higher at weeks 24, 52, and 76 (all 

 <.001), demonstrating durable disease control.

BESTOW: Tegoprubart Showcases Safer Prevention of Kidney Transplant Rejection Over Tacrolimus

Phase 2 BESTOW trial data suggest tegoprubart offers similar improvements in estimated glomerular filtration rate (eGFR) as tacrolimus while providing a better safety profile, potentially shifting the transplant immunosuppression paradigm.

Global Data Support Successful Pregnancy Outcomes in Kidney Transplant Recipients

Registry analyses from multiple continents show that pregnancy after kidney transplantation can be successfully managed, with favorable maternal, neonatal, and graft outcomes. These findings highlight the importance of close clinical surveillance and the need for continued global data harmonization to support high-risk pregnancies/

FDA Grants Orphan Drug Designation to ABBV-CLS-628 for ADPKD

The FDA granted orphan drug designation to ABBV-CLS-628 for autosomal dominant polycystic kidney disease (ADPKD). Although early in development, this designation underscores ongoing efforts to expand treatment options for rare kidney diseases and supports continued research into disease-modifying therapies.

November saw significant advancements in nephrology, with notable developments in IgA nephropathy (IgAN) management, including FDA approvals and promising trial results. Emerging therapies like sibeprenlimab, telitacicept, and atacicept show potential in reducing proteinuria and improving biomarkers. Progress in focal segmental glomerulosclerosis (FSGS) and membranous nephropathy highlights agents like sparsentan and MIL62. Kidney transplantation and immunosuppression advancements, including tegoprubart, offer new insights. Additionally, FDA orphan designations and trial data continue to expand the therapeutic landscape for chronic kidney disease (CKD) and rare kidney disorders.

Key FDA approvals, pivotal IgAN and glomerular trial results, and transplant and CKD insights from November 2025.


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.

IgA Nephropathy

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

FDA News

Chronic Kidney Disease

8 Nephrology Headlines You Missed in November 2025

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.

Sharon Barr, Executive Vice President of BioPharmaceuticals R&D | Image Credit: NLS

 has announced its Priority Review acceptance of a New Drug Application (NDA) for baxdrostat, an investigative potential first-in-class small molecule aldosterone synthase inhibitor, for the treatment of 

Announced on December 2, 2025, by parent company AstraZeneca, the NDA submission was based on positive results from the BaxHTN phase 3 clinical trial. This study investigated multiple doses of baxdrostat compared to placebo in lowering systolic blood pressure among patients with uncontrolled hypertension despite the use of ≥2 antihypertensive medications.

“This Priority Review demonstrates our commitment to advancing baxdrostat as a potential first- and best-in-class aldosterone synthase inhibitor for the millions of people living with hard-to-control hypertension as quickly as possible,” Sharon Barr, executive vice president of BioPharmaceuticals R&D, said in a statement. “The substantial reduction in systolic blood pressure seen in the BaxHTN trial underscores baxdrostat’s novel mechanism of action and its potential to bring innovation to a disease area that has seen limited progress over two decades.”

BaxHTN was a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel group study aiming to evaluate the safety, tolerability, and efficacy of baxdrostat in patients with uncontrolled hypertension being treated with ≥2 different antihypertensive medications. The trial was conducted at 263 locations worldwide and saw patients randomly assigned in a 1:1:1 ratio to either baxdrostat 2 mg, baxdrostat 1 mg, or placebo once daily. The study’s primary efficacy endpoint was the difference in mean change from baseline in seated systolic blood pressure at week 12 between participants treated with baxdrostat and those treated with placebo. The efficacy’s persistence was assessed during a randomized withdrawal period from week 24 to 32.

To be eligible for inclusion, patients were required to have a mean sitting systolic blood pressure of ≥140 mmHg and ≤170 mmHg based on automated office blood pressure measurements, as well as an estimated glomerular filtration rate ≥45 mL/min/1.73m2 and a serum potassium level ≥3.5 and <5 mmol/L at screening. Patients also had to have a stable regimen of either 2 or ≥3 antihypertensive medications from different classes at the maximum dose, of which ≥1 must be a diuretic. Patients with a mean sitting systolic blood pressure ≥170 mmHg, a mean seated diastolic blood pressure ≥110 mmHg, serum sodium levels <135 mmol/L, or New York Heart Association functional 

 class IV at screening, among other criteria, were excluded.

A total of 796 patients were included in the study and were randomized to either baxdrostat 2 mg (n = 266), 1 mg (n = 264), or placebo (n = 264). At 12 weeks, investigators saw a -14.5 mmHg change from baseline in mean systolic blood pressure (95% CI, -16.5 to -12.5) with baxdrostat 1 mg, -15.7 mmHg (95% CI, -17.6 to -13.7) with baxdrostat 2 mg, and -5.8 mmHg (95% CI, -7.9 to -3.8) with placebo. The estimated difference from placebo was -8.7 mmHg (95% CI, -11.5 to -5.8) with baxdrostat 1 mg and -9.8 mmHg (95% CI, -12.6 to -7) with baxdrostat 2 mg (

“Many people continue to struggle with high blood pressure that is hard to control, even when taking multiple medications,” Bryan Williams, chair of medicine at University College London and a lead investigator in BaxHTN, said in a statement. “The highly promising BaxHTN phase 3 results show that once-daily baxdrostat on top of standard care can meaningfully lower systolic blood pressure and offer a potential new treatment approach for controlling hypertension, the leading risk factor for cardiovascular disease.”

According to the press release, AstraZeneca expects to receive the Prescription Drug User Fee Act date during the second quarter of 2026, following the use of a Priority Review voucher.

AstraZeneca. Baxdrostat New Drug Application accepted under FDA Priority Review in the US for patients with hard-to-control hypertension. December 2, 2025. Accessed December 2, 2025. 

https://www.astrazeneca-us.com/media/press-releases/2025/Baxdrostat-New-Drug-Application-accepted-under-FDA-Priority-Review-in-the-US-for-patients-with-hard-to-control-hypertension.html

AstraZeneca. A Study to Investigate the Efficacy and Safety of Baxdrostat in Participants With Uncontrolled Hypertension on Two or More Medications Including Participants With Resistant Hypertension (BaxHTN). ClinicalTrials.gov Identifier: NCT06034743. Updated July 11, 2025. Accessed December 2, 2025. 

https://clinicaltrials.gov/study/NCT06034743

Flack JM, Azizi M, Brown JM, et al. Efficacy and safety of Baxdrostat in uncontrolled and resistant hypertension. New England Journal of Medicine. 2025;393(14):1363-1374. 

AstraZeneca. Baxdrostat met the primary and all secondary endpoints in BaxHTN Phase III trial in patients with uncontrolled or treatment resistant hypertension. July 14, 2025. Accessed December 2, 2025. 

https://www.astrazeneca-us.com/media/press-releases/2025/baxdrostat-met-the-primary-and-all-secondary-endpoints-in-BaxHTN-Phase-III-trial-in-patients-with-uncontrolled-or-treatment-resistant-hypertension.html

The FDA has accepted a Priority Review for baxdrostat, a novel aldosterone synthase inhibitor, for treating hard-to-control hypertension. AstraZeneca's NDA submission is based on positive BaxHTN phase 3 trial results, which demonstrated significant reductions in systolic blood pressure among patients with uncontrolled hypertension on multiple antihypertensive medications. The trial involved 796 patients and showed that baxdrostat significantly lowered systolic blood pressure compared to placebo. AstraZeneca anticipates a Prescription Drug User Fee Act date in the second quarter of 2026, following the Priority Review process.

The submission follows positive results from the BaxHTN trial, which saw the investigational aldosterone synthase inhibitor improve systolic BP versus placebo.

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...

Hypertension

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

Baxdrostat NDA for Uncontrolled Hypertension Receives FDA Priority Review

Biofrontera Inc. announced the submission of a supplemental New Drug Application (sNDA) to the 

 for Ameluz-PDT (photodynamic therapy) as a treatment for superficial basal cell carcinoma (sBCC).

This December 2 announcement highlights Biofrontera’s sNDA and its incorporation of the complete efficacy results from recent phase 3 research and 1-year follow-up. The company also highlighted its combined safety analysis drawing from both European and US clinical trials in basal cell carcinoma.

“The efficacy, tolerability, and aesthetic outcomes demonstrated in the Phase 3 study and highlighted in our publication reinforce the value of Ameluz-PDT for the treatment of sBCC,” Todd Schlesinger, MD, director of the Clinical Research Center of the Carolinas in Charleston, South Carolina, and first author of the recent phase 3 results, said in a statement.

 “I look forward to potentially having this as an approved option for my patients with sBCC.”

Actinic keratosis (AK) is a precancerous lesion known to result from long-term sun exposure, with related lesions most often appearing on chronically sun-exposed sites. AK can also progress to squamous cell carcinoma if the condition remains untreated. An estimated 58 million people in the US in 2020 were impacted by AK, with about 13 million treatments taking place.

In Biofrontera’s announcement, they highlighted basal cell carcinoma (BCC) as the most frequently diagnosed skin cancer nationally, pointing to the over 3 million new cases reported each year. Ameluz-PDT is designed to help address sBCC, a subtype of BCC. If the treatment is cleared by FDA officials, its updated label would permit the use of Ameluz with either the BF-RhodoLED or RhodoLED XL red-light devices for sBCC.

In Biofrontera’s recent phase 3 analysis prior to their sNDA, a double-blind, randomized, placebo-controlled, multicenter study design was used. There were a total of 187 individuals who had at least a single clinically and histologically confirmed superficial BCC included in the study.

 These subjects were given a treatment cycle consisting of 2 PDT sessions with Ameluz-PDT or placebo-PDT. These sessions were administered 1 - 2 weeks apart, with a second cycle provided 3 months later if warranted.

The investigative team’s main endpoint evaluated in their analysis was complete clinical and histologic clearance of a designated main target lesion (MTL) at the 12-week mark following the last cycle of PDT. This benchmark was attained by 65.5% of study participants treated with Ameluz-PDT (95 of 145) as opposed to only 4.8% of subjects in the placebo arm of the analysis.

 This was a difference shown by the investigators to be statistically significant (P < .0001).

In their secondary analyses, even greater relative benefits to Ameluz-PDT were demonstrated by investigators. Histologic clearance of the MTL was observed among 75.9% of those on the treatment, compared with 19.0% in the placebo cohort. Attainment of clinical clearance of the MTL was also observed among 83.4% of the those in the treatment cohort versus 21.4% of those on placebo. Complete clearance of all superficial BCC lesions was also observed by the investigative team in 64.1% of those on Ameluz, compared with 4.8% of participants on the placebo.

 All such comparisons achieved high statistical significance (P < .0001).

The investigators pointed to the alignment of patient-reported outcomes with these clinical findings. Specifically, they highlighted 85.5% of individuals who had rated their satisfaction with Ameluz-PDT and its cosmetic effects to be good or very good. Results from the company’s 1-year follow-up interactions supported the persistence of response. These data would indicate a low rate of recurrence along with sustained cosmetic benefits.

“We are delighted that these highly significant results align with those found in the European studies and that we were able to submit this data package to FDA and seek an extension of the label to include sBCC,” Hermann Luebbert, PhD, CEO and Chairman of Biofrontera Inc., said in a statement.

 “If approved, this would expand the Ameluzindication to cutaneous oncology and would represent a significant milestone in our mission to become market leaders in the field of PDT.”

Biofrontera Inc. Announces Filing of Supplemental New Drug Application (sNDA) for the Treatment of Superficial Basal Cell Carcinoma (sBCC) with Ameluz®-PDT. Biofrontera Inc. December 2, 2025. 

https://www.globenewswire.com/news-release/2025/12/02/3197970/0/en/Biofrontera-Inc-Announces-Filing-of-Supplemental-New-Drug-Application-sNDA-for-the-Treatment-of-Superficial-Basal-Cell-Carcinoma-sBCC-with-Ameluz-PDT.html

Actinic Keratosis Overview. The Skin Cancer Foundation. 

https://www.skincancer.org/skin-cancer-information/actinic-keratosis/

Biofrontera Inc. has submitted a supplemental New Drug Application to the FDA for Ameluz-PDT, targeting superficial basal cell carcinoma (sBCC). The application includes efficacy results from a recent phase 3 study and a 1-year follow-up, demonstrating significant clinical and histologic clearance rates. The study showed Ameluz-PDT's superiority over placebo in achieving clearance of sBCC lesions. Patient satisfaction with the treatment's cosmetic effects was high, and the data indicated a low recurrence rate. Approval would expand Ameluz's indication to include cutaneous oncology.

Biofrontera announced its submission of a supplemental New Drug Application to the FDA for Ameluz-PDT in superficial basal cell carcinoma (sBCC).

sNDA for Ameluz-PDT as a Treatment for Superficial Basal Cell Carcinoma Submitted to FDA

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

PR was seen to reduce FeNO, a biomarker of type 2 inflammation, in a new study.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

Pulmonary Rehabilitation Reduces Type 2 Inflammation in High Inflammation Asthma

A groundbreaking trial reveals the effectiveness of aggressive LDL lowering in high-risk patients, showcasing significant improvements in cholesterol management.

Video Series

VICTORION-INCEPTION and the Evolving Role of Inclisiran in ASCVD

Sayna Norouzi, MD, is an assistant professor of medicine, clinical nephrologist, and founder and director of the glomerular disease and polycystic kidney disease clinics at Loma Linda University Medical Center.

This episode focuses on the underlying biology of IgA nephropathy, particularly the “multi-hit hypothesis.”

Pathophysiology of IgAN

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

This month in review spotlights 5 top allergy headlines published in November, including late-breaking data at ACAAI 2025.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

5 Allergy Headlines You Missed in November 2025

Discover the critical importance of early LDL lowering with PCSK9 inhibitors to reduce cardiovascular risks and improve patient outcomes.

Expanding the Role of PCSK9 Inhibitors in ASCVD Treatment

In this segment, the panel focuses on what “optimized supportive care” truly means for patients with IgA nephropathy.

Optimizing Supportive Care for IgAN

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.

Catch up on GI FDA news, new American Gastroenterological Association Crohn’s disease guidelines, and more gastroenterology updates from November.

Gastroenterology

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

, IBS and IBD, Crohn's disease, and more.

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

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5 Gastroenterology Headlines You Missed in November 2025

Paul Sorajja, MD, is the associate director of the Banner – University Medicine Heart Institute and professor of medicine at the University of Arizona. 

Sorajja discusses the results of this groundbreaking trial investigating a new implant for patients with severe mitral annular calcification.

Heart Failure

The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

SUMMIT-MAC: Tendyne System Improves Mortality in MAC, With Paul Sorajja, MD

New data support firsekibart's efficacy over colchicine for preventing acute gout flares.

Gout

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Rheumatology

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Firsekibart Beats Colchicine as Gout Flare Prophylaxis When Initiating ULT

Gerard Criner, MD, is chair and professor of thoracic medicine and surgery at Lewis Katz School of Medicine at Temple University and director of the Temple Lung Center.

Discover how precision medicine reshapes COPD treatment, focusing on inflammation and patient-specific traits for improved outcomes in airway diseases.

COPD

COPD condition center page, resources on the topics of medical news and expert insight into chronic obstructive pulmonary disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on COPD research, treatment, and drug development.

Latest News

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