Biofrontera's Ameluz (aminolevulinic acid hydrochloride) topical gel, 10%, paired with the BF-RhodoLED lamp series, has received an approval by the 

 approval for superficial basal cell carcinoma (sBCC) in adults.¹ The approval makes photodynamic therapy (PDT) the first modality of its kind cleared to treat a skin cancer in the US.¹˒²

Basal cell carcinoma is diagnosed in an estimated 3.6 million patients annually in the US, and superficial subtypes account for approximately 540,000 to 720,000 of those cases each year.¹ Lesions are often multiple and located on the trunk and extremities, and non-surgical, tissue-sparing options for this population have remained limited.¹ Mohs surgery, electrodesiccation and curettage, and topical imiquimod have served as the primary alternatives to date.

In the pivotal phase 3 trial, 66% of patients treated with Ameluz PDT achieved composite clinical and histological clearance of the main target lesion at 12 weeks (95/145), versus 5% with placebo-PDT (2/42).¹ Histological clearance reached 76% with Ameluz PDT versus 19% with placebo-PDT, and complete clinical clearance of all target lesions reached 83% versus 21%.¹ Application-site reactions were the most common adverse events reported, consistent with the known safety profile of Ameluz PDT.¹

For dermatologists, the data offer a tissue-sparing alternative for lesions in areas where surgery carries added risk. Neal Bhatia, MD, director of clinical dermatology at Therapeutics Clinical Research in San Diego, California, treats skin cancer and has followed PDT development for years. In this Q&A summary of his interview, he discusses how the approval reshapes patient counseling and how the efficacy data stack up against surgical benchmarks.

: What does it mean for dermatology to have the first FDA-approved photodynamic therapy regimen for skin cancer?

Well, for me, who's kind of a PDT nut, I'm actually very thrilled. It's nice to see yet another advanced use for photodynamic therapy. Red light PDT has been established with us for decades, brought to us with 16% methyl ALA, and now with 10% ALA in the gel, we've really got some good options. I'm actually very excited to see how photodynamic therapy can work on basal cell especially, but it's been used off-label with both red and blue light for different kinds of tumors.

We've had lots of different things in the hopper for photodynamic therapy, but the mainstays being actinic keratosis, acne, and some other indications for cutaneous T-cell lymphoma with different light. For me, I am always a fan of non-surgical alternatives. Mohs surgery is still the gold standard. Electrodesiccation and curettage is an easy treatment option for superficial basal cell, as has topical imiquimod for years, among several others. But I think of elderly patients, hard-to-treat areas like the pretibial surfaces, behind the ears, near the eyelids, areas where surgery may not be the easiest option.

I don't want to ever say best option, but the easiest option. Patients on anticoagulants, patients on oxygen, there's always ways to think about where I can use something that doesn't involve surgery but still has efficacy for tumor clearance. This is where we now have a really good option in front of us. There's a smaller light, the BF-RhodoLED, and there's going to be a bigger panel light, so there are a lot of options for using red light. The opportunities here are pretty rich for us.

: How might this approval change how you counsel superficial BCC patients who would otherwise go straight to surgery?

 I think where we once were just saying we have to cut this out, now we take into account whether there's another way to minimize scarring, which photodynamic therapy is good at. PDT also treats the innocent skin, if you will, the photoaged skin around the tumor rather than just the tumor itself. A lot of the studies with red light as well as blue light have treated this photodamaged surrounding skin, so there's a bit of an inadvertent field effect, but we're getting treatment of the surrounding skin as well as the tumor, so that's also a plus.

There's also a benefit to think about with multiple cycles, are we getting the treatment response we want? As we saw in the study, 66% of patients cleared over 12 weeks, compared to 5% in the placebo plus light arm, so that was a really good opportunity to show the value of the photosensitizing element. The other part of the equation is I look at the number of patients diagnosed with superficial basal cell, but also the numbers who are early in that stage. If we get patients treated for actinic keratoses and find an incidental basal cell that clears, that's also an approved treatment now, so there's an upside there.

There are a lot of good ways to position PDT now. In terms of office settings, whether a private equity clinic, a freestanding practice, or an institution, incorporation of a light device, whether blue or red, photodynamic therapy has to be part of a practice to really treat these areas and serve as a chemoprevention strategy too.

: How do you weigh a 66% composite complete response rate against the reliability of Mohs surgery?

Mohs surgery being the gold standard of surgical procedures for skin cancer, it's hard to match 98% efficacy, and I wouldn't say I'd rather do this than that. I'd approach it more from the candidacy of the patient, their health, the location of the tumor, and how many surgeries they've had. There are a lot of factors in that respect. I'd also think about a younger person in a very cosmetically sensitive area: if they don't want surgery, how viable an option is this?

PDT, if anything, improves the texture of the skin rather than leaving a surgical scar, so we may see a cosmetic benefit from not having surgery. But I wouldn't be the one to say stop the surgeries, you don't need Mohs anymore. I'd say we now have a better option than cryotherapy, and something we can use in conjunction with imiquimod if needed. I look at the opportunity to use photodynamic therapy as a treatment modality, and with this data, it's very strong. It's a very useful tool for us to consider putting into motion in the practice.

Editor’s note: This transcript has been edited for grammar and clarity using artificial intelligence tools. Bhatia had no relevant financial disclosures of note.

Biofrontera Inc. Biofrontera announces FDA approval of Ameluz Red Light PDT for the treatment of superficial basal cell carcinoma. Published September 14, 2026. Accessed September 17, 2026. 

https://www.globenewswire.com/news-release/2026/09/14/3361199/0/en/biofrontera-announces-fda-approval-of-ameluz-red-light-pdt-for-the-treatment-of-superficial-basal-cell-carcinoma.html

Smith T. Ameluz treatment becomes first FDA-approved PDT for skin cancer. HCPLive. Published September 17, 2026. Accessed September 16, 2026. 

https://www.hcplive.com/view/ameluz-treatment-becomes-first-fda-approved-pdt-skin-cancer

Articles

Neal Bhatia, MD, weighs the newly approved Ameluz PDT regimen for sBCC against Mohs surgery, citing its 66% composite response rate.

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Q&A: What the First FDA-Approved PDT for Skin Cancer Means for sBCC Care

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

2026 European Respiratory Society (ERS) Congress

, held September 5 to 9 in Barcelona, Spain, delivered a late-breaking program with meaningful breadth across chronic obstructive pulmonary disease (COPD), asthma, idiopathic pulmonary fibrosis (IPF), and alpha-1 antitrypsin deficiency (AATD)— including the first phase 3 data for an IL-33 antagonist in COPD exacerbation prevention, early clinical results from a genetic correction program in AATD, and new findings on antifibrotic tolerability and novel cough mechanisms in IPF. Here are 6 late-breaking updates from the meeting that clinicians managing respiratory disease should know.

1. Tozorakimab Cuts COPD Exacerbations Across Eosinophil Levels: Frank Sciurba, MD

Replicate phase 3 data from OBERON and TITANIA showed tozorakimab reduced moderate and severe COPD exacerbations by 29%–34% in former smokers, with benefit extending across eosinophil strata — including a 23% reduction in patients with a blood eosinophil count below 150 cells/µL, a population largely excluded from benefit with prior COPD biologics. A separate poster from the same program showed tozorakimab also reduced mucus plug burden on CT imaging, making it the first COPD biologic to demonstrate that effect in a broad population.

Tozorakimab Cuts COPD Exacerbations Across Eosinophil Levels: Frank Sciurba, MD

2. FIBRONEER-ON: Nerandomilast's Durable IPF, PPF Safety, With Wim Wuyts, MD, PhD

Interim data from the open-label extension of the phase 3 FIBRONEER trials showed nerandomilast's favorable safety profile held with longer-term use across 1,643 patients with IPF and progressive pulmonary fibrosis, with adverse-event discontinuations under 11% and diarrhea — the most common adverse event — prompting discontinuation in fewer than 1% of patients overall. Only 1.7% of patients required a dose reduction from 18 mg to 9 mg twice daily, which Wuyts described as an indirect sign of the drug's tolerability, with longer-term FVC and quality-of-life data from the extension still to come.

3. TRPA1 Antagonist Shows Delayed but Meaningful Effect on IPF Cough

A phase 2a/2b trial of BI 1839100, a selective oral TRPA1 antagonist, missed its week-4 co-primary endpoint for cough reduction in IPF but showed a 45.5% reduction in 24-hour cough count relative to placebo by week 12, with accompanying reductions in daytime cough count and cough bouts. Wijsenbeek said the mismatch between the two timepoints likely reflects the drug being assessed too early rather than a lack of effect, and called for a new trial designed with a later primary endpoint to properly capture the apparent delayed benefit.

TRPA1 Antagonist Shows Delayed but Meaningful Effect on IPF Cough

4. BEAM-302 Base Editing Sustains Protective AAT, With John Hurst, MBBS, PhD

Initial phase 1/2 data showed a single dose of BEAM-302 — a first-in-human in vivo base-editing therapy that corrects the disease-causing SERPINA1 mutation directly in the liver — durably raised functional AAT above the 11-µM emphysema-protection threshold in patients with severe AATD, with doses at or above 60 mg producing roughly 80% reductions in circulating mutant Z-AAT. No serious treatment-related adverse events had been reported, and treated patients also showed reduced levels of polymerized Z-AAT, a proinflammatory species implicated in AATD-related lung damage that no prior intervention had been shown to reduce.

5. Zumilokibart Rapidly Suppresses FeNO in Phase 1b Asthma Data: Mario Castro, MD

A single 720-mg subcutaneous dose of zumilokibart (APG777), a long-acting anti-IL-13 antibody with a half-life of approximately 75 days, produced a 60% mean reduction in FeNO by week 2 in patients with mild-to-moderate asthma, with suppression maintained above 50% through week 32. Castro said the drug's extended half-life could support dosing as infrequent as every 3 to 6 months, potentially reducing treatment burden and helping close the post-exacerbation coverage gap that contributes to hospital readmissions.

6. Verekitug Reduces Asthma Exacerbations Up to 87%, With Michael Wechsler, MD

Verekitug is a TSLP receptor antagonist — a mechanistically distinct approach from tezepelumab, which targets the ligand itself — and the VALIANT phase 2 trial presented the first controlled efficacy and safety data for this class in severe asthma. Wechsler walks through the trial design, key findings, and what the results suggest for the future of TSLP-targeted therapy in severe asthma.

Verekitug Reduces Asthma Exacerbations Up to 87%, With Michael Wechsler, MD

Late-breaking ERS 2026 data expanded biologic and genetic approaches across obstructive and fibrotic lung disease. The IL‑33 antagonist tozorakimab lowered COPD exacerbations in smokers regardless of eosinophils and reduced CT mucus plugging. Nerandomilast maintained favorable long-term tolerability in IPF and progressive pulmonary fibrosis, with minimal dose reductions and rare diarrhea-related discontinuation. A selective TRPA1 antagonist showed week‑12 cough reductions despite an early endpoint miss. In severe AATD, in vivo base editing with BEAM‑302 increased functional AAT and suppressed mutant Z‑AAT. New asthma programs targeted IL‑13 and TSLP receptors.

Read 6 late-breaking updates from ERS Congress 2026 that clinicians managing respiratory disease should know.

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ERS Congress 2026: 6 Late-Breaking Trials to Know

European Respiratory Society (ERS) Congress 2026

 in Barcelona, Spain, held September 5 to 9, one of the more forward-looking conversations in the severe 

 track centered not on a new biologic or an approval, but on a transcription factor: signal transducer and activator of transcription 6 (STAT6), the intracellular convergence point for interleukin (IL)-4 and IL-13 signaling. The emerging interest reflects a therapeutic proposition that would have been difficult to imagine a few years ago — an oral small molecule capable of reproducing, at least mechanistically, what injectable type 2–targeted biologics accomplish, and doing so at a step in the inflammatory cascade that no approved asthma therapy currently reaches.

STAT6 sits downstream of the IL-4 receptor alpha subunit, the receptor that dupilumab blocks to inhibit both IL-4 and IL-13 signaling. Once activated, STAT6 translocates to the nucleus and drives transcription of the genes underlying type 2 inflammation. Blocking or removing STAT6, in principle, interrupts that program regardless of how much upstream cytokine is present.

"STAT6, it's really a great molecule. It's a key intracellular signaling protein that is involved in type 2 pathways, especially the IL-4/IL-13 pathway," Florence Schleich, MD, PhD, a respiratory physician at the University of Liège in Belgium, told 

. "If you block STAT6, it's an intracellular blockade, because STAT6 is going into the nucleus and inducing the transcription of the inflammatory genes for type 2 inflammation. So it's a great opportunity to have a new target in the future."

A Downstream Mechanism in an Upstream Era?

Much of the recent innovation in obstructive airway disease has moved toward the epithelial alarmins — thymic stromal lymphopoietin (TSLP) and IL-33 — which act at the top of the inflammatory cascade. STAT6 degradation moves in the opposite direction, intervening well downstream of those signals.

"Oral STAT6 degraders work further downstream compared to the epithelial alarmin targeted therapies like ones that target TSLP or IL-33," said Michael E. Wechsler, MD, MMSc, of National Jewish Health in Denver, Colorado. "The STAT6 degraders work downstream and degrade some of the downstream signaling pathways mediated by Janus-activated kinases and STAT6 and STAT5, for example."

The rationale for pursuing STAT6 in asthma has been built substantially on early data from atopic dermatitis, another type 2–driven disease. "The STAT6 degrader that you were talking about has been shown to be effective in atopic dermatitis, and there's reason to believe that it may be effective in asthma as well," Wechsler said. "One of the benefits of that therapy is that it's an oral therapy, and because some patients prefer to take pills, this may have beneficial effects as well."

The degrader drawing the most attention is Kymera Therapeutics' KT-621, described by the company as a first-in-class, once-daily oral degrader of STAT6.

 In the 22-participant phase 1b BroADen trial in moderate-to-severe atopic dermatitis, KT-621 achieved median STAT6 reductions of 94% in skin and 98% in blood across the 100 mg and 200 mg dose groups, alongside a mean 63% reduction in Eczema Area and Severity Index (EASI) scores and a 40% reduction in peak pruritus numerical rating scale scores at 4 weeks, with no treatment-related adverse events reported.

 Notably for the airway field, participants with comorbid asthma showed a median 56% reduction in fractional exhaled nitric oxide (FeNO).

 Kymera has since advanced KT-621 into parallel phase 2b trials — BROADEN2 in atopic dermatitis and BREADTH in asthma — with asthma data expected in late 2027, and the US Food and Drug Administration has granted the program Fast Track designation in both moderate-to-severe atopic dermatitis and moderate-to-severe asthma.

 These are early-phase and largely company-reported findings, and the atopic dermatitis results have not yet been evaluated in a phase 3 asthma population.

Wechsler was measured on that distance. "There's a long way to go from being a concept in atopic dermatitis to moving past phase three and into the FDA and getting approval, but I think based on the mechanism, there's a strong rationale for it. Based on the preliminary data in atopic dermatitis, there's a strong rationale for it as well."

The clinical interest in STAT6 degradation is less about displacing existing biologics than about reaching patients those biologics do not. Njira Lugogo, MD, professor of medicine and asthma program director at the University of Michigan in Ann Arbor, framed the pathway as a way to potentially deliver a biologic-like effect through an oral route.

"Your IL-4 and 13 downstream inflammatory effects are modulated via STAT6," Lugogo said. "Before you get to the production of the inflammatory proteins, you have STAT6 as the common pathway for IL-4 and 13. So, theoretically, targeting STAT6 should inhibit both IL-4 and 13 effects. Our only current drug that inhibits IL-4 and 13 simultaneously is dupilumab by blocking the IL-4 receptor alpha, which is the predominant effector receptor for IL-13. So we could imagine a time where we have an oral drug that has the ability to replicate what we're doing with biologics, and that really opens the space entirely."

Lugogo outlined several distinct positions an oral STAT6 degrader might occupy. The first is dual targeted therapy for partial responders. "Could STAT6 inhibition be a way to achieve dual targeted therapy? That's a potential option where patients are already on a biologic and perhaps not fully responding," she said, pointing specifically to partial responders and those with discordant upper and lower airway disease.

The second is a pre-biologic role, particularly where access is a barrier. "Could it be a pre-biologic? Potentially patients who you're thinking need to go on biologic, you've maximized inhaled therapy, you're not quite so sure that you want to use a biologic or the patient can't use a biologic," Lugogo said. "There are really quite a few places in the world where biologic penetrance is so poor because of all the logistical issues, the cold chain delivery, and so forth, so could an oral agent in that population be an option?"

A third potential use is early intervention in high-risk populations, an area of growing research interest across several mechanisms. Lugogo noted that an oral therapy "could be used in a wider population, maybe more accessible" for the kind of early-intervention trials the field increasingly wants to run.

Finally, she raised an inhaled corticosteroid (ICS)–sparing role, framed against ongoing efforts to reduce high-dose ICS exposure. "There is a huge focus on inhaled corticosteroid safety and mitigating that, reducing high-dose inhaled corticosteroid exposure. That therefore allows us to rethink whether we could have STAT6 therapy as an add-on and ICS-sparing therapy."

The through-line across all 4 scenarios is access. "The majority of asthma patients really can't access targeted therapy. Currently, it's for the most severe population," Lugogo said. "As we want to expand the population and really improve outcomes, I can envision this as being just a really amazing way to expand the population and hopefully achieve a biologic-like response in those patients."

The enthusiasm is consistently paired with caution, and the caution centers on safety — an unavoidable consideration for any oral agent that suppresses an intracellular signaling node systemically. Schleich noted that the safety profile, once mature, could shape the route of administration itself.

"We will have to see the data, especially regarding safety," Schleich said. "If there are safety concerns, could move to inhalation treatment, inhalation anti-STAT6 treatment, as we did for ICS, because there were side effects with OCS. Could be a good way to move on to inhalation therapy, but it's pure speculation for the future."

That unmet need is what keeps the pathway compelling despite its early stage. As Wechsler noted, remission remains elusive for most patients even in the biologic era. "For patients with asthma, we're doing a good job of getting some people into remission, but really only 25 to 40% of patients get into remission, and that suggests that we need to give the right drugs to the right patient at the right time, and we might need other targeted strategies. So STAT6 offers a novel targeted strategy for our patients as well."

For now, STAT6 degradation remains a concept validated primarily in a different organ system and awaiting its first controlled asthma readout. Lugogo, for her part, was clear about both the uncertainty and the appeal. "It's very early. It's emerging, but I think it's extremely promising, and I'm quite excited to see the direction that it goes in over the next few years."

Relevant disclosures for Schleich include

AstraZeneca and GSK; Wechsler’s disclosures include Genzyme, Regeneron, AStraZeneca, GSK, and Pfizer;  Lugogo’s disclosures include AbbVie, Amgen, Apogee Therapeutics, AstraZeneca, Foresee Pharmaceuticals, Genentech, GSK, Incyte, Niox, Regeneron, Sanofi and Teva Pharmaceuticals.

Kymera Therapeutics. Kymera Therapeutics announces positive results from BroADen phase 1b clinical trial of KT-621, a first-in-class, oral STAT6 degrader, in patients with moderate to severe atopic dermatitis. Press release. December 2025. Accessed September 17, 2026. https://investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-announces-positive-results-broaden-phase-1b

Kymera Therapeutics. Kymera Therapeutics presents KT-621 BroADen data in late-breaking research session at the American Academy of Dermatology (AAD) Annual Meeting. Press release. March 28, 2026. Accessed September 17, 2026. https://investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-presents-kt-621-broaden-data-late-breaking

Kymera Therapeutics. Kymera Therapeutics announces first quarter 2026 financial results and provides a business update. Press release. 2026. Accessed September 17, 2026. https://firstwordpharma.com/story/7252952

At ERS 2026, pulmonologists framed oral STAT6 degradation—led by Kymera's KT-621—as a potential biologic-like, access-expanding approach.

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.

STAT6 Degradation: A Novel Oral Target for Asthma?

Astrid Paul Nordin, MD, PhD, is a consultant cardiologist in electrophysiology at the Karolinska University Hospital.

Adjunctive low-voltage zone (LVZ) ablation on top of pulmonary vein isolation (PVI) improves both rhythm outcomes and quality of life in patients with persistent 

Low-Voltage Zone Ablation After Pulmonary Vein Isolation Improves Rhythm Outcomes in AF

European Society of Cardiology (ESC) Congress 2026

 in Munich, Germany, by Astrid Paul-Nordin, MD, PhD, a consultant cardiologist in electrophysiology at the Karolinska University Hospital.

“If you have a patient with a low-voltage zone, you should ablate it in the first procedure,” Nordin told 

 in an exclusive interview. “But I also think that you should choose those patients to go for voltage mapping and point-by-point ablation, and not for a single-shot device at the first procedure.”

The Individually Designed Ablation of Low-Voltage Areas in Persistent Atrial Fibrillation (IDEAL-AF) study was a multicenter, single-blind, investigator-initiated, randomized clinical trial, comparing PCI plus LVZ ablation with PVI alone. Patients were eligible for inclusion if they had electrocardiogram-documented persistent or long-standing persistent AF and were scheduled for first-time catheter ablation and met guideline-based indications. Patients were excluded if they had left atrial diameter >55 mm, recent acute coronary syndrome, or congenital heart disease, among other criteria.

Nordin and colleagues selected a primary outcome of freedom from documented atrial arrhythmia without antiarrhythmic drugs at 12 months after 1 or 2 ablation procedures within 6 months. Secondary outcomes included time to first recurrence after a single procedure without antiarrhythmic drugs, health-related quality of life, and safety.

Patients with ≥1 LVZ measuring ≥3.0 cm2 outside of PVI lines were classified as having significant left atrial substrate. Following PVI, these patients were randomly assigned in a 1:1 ratio to receive either individualized adjunctive LVZ ablation or no further ablation. In the PVI plus LVZ ablation arm, ablation was tailored to substrate location via homogenization, box isolation, linear lesions, or any combination thereof. After ablation, burst pacing from the coronary sinus was performed in both groups.

Patients were then followed up at 3, 6, and 12 months after index ablation. Investigators monitored heart rhythm using handheld single-lead electrocardiogram recordings, which were obtained whenever patients experienced symptoms suggestive of arrhythmia or at the patients’ own discretion. Patients also performed scheduled electrocardiogram recordings twice daily for 14 days before each follow-up visit.

A total of 209 patients were enrolled in the trial, with a median age of 72 years. Among these patients, arrhythmia-free survival occurred in 69 patients (67.6%) in the LVZ arm compared to 40 patients (37.4%) in the PVI-only arm (unadjusted difference, 30.3%; 95% CI, 17.4-43.2%; odds ratio, 3.5; 95% CI, 2-6.2; 

 <.001). Time to first recurrence after a single ablation procedure without antiarrhythmic drugs also occurred more often in the LVZ arm (HR, 0.4; 95% CI, 0.3-0.6; 

Ultimately, Nordin and colleagues concluded that adjunctive LVZ ablation following PVI successfully improved rhythm outcomes and health-related quality of life without increasing serious adverse events in this patient population.

“Of course, it comes with some negative effects; if you have to ablate more, you will have more fluoroscopy, and more ablation time, and longer procedures,” Nordin said. “But we have such clear results that the patients benefit from it, and we did not see any difference in safety outcomes, so I think it’s a good thing to do the low-voltage zone ablation, even if you have a more complex procedure.”

Editors’ Note: Paul-Nordin reports disclosures with Johnson & Johnson MedTech.

Paul Nordin A. IDEAL-AF: Individualized Low Voltage Ablation in Persistent AF. Presented at the European Society of Cardiology (ESC) Congress 2026, Munich, Germany. August 28-31, 2026.

Paul Nordin A, Charitakis E, Carnlöf C, et al. Low-Voltage Ablation in Persistent Atrial Fibrillation: The IDEAL-AF Randomized Clinical Trial. 

. Published online August 30, 2026. Accessed September 17, 2026. 

Videos

Astrid Paul Nordin, MD, PhD, discusses the results of the IDEAL-AF trial, highlighting the efficacy of including LVZ on top of PVI.

Cardiology

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Arrhythmia

George Vasquez-Rios, MD, MSCR, FASN, is a nephrologist and glomerular disease specialist and director of the Glomerular & Genetic Diseases Center.

An estimated 200 glomerular disease specialists practice across the US and Canada, with some states lacking an expert within 200 miles, a scarcity that puts real weight on how early general clinicians recognize a glomerular disease before a referral ever happens.¹

George Vasquez-Rios, MD, MSCR, FASN, Director of the Glomerular and Genetic Diseases Center at Renal Medicine Associates, discussed how general clinicians can recognize glomerular disease earlier and navigate referral pathways as part of the 

's new Glomerular Diseases Collaborative (GD-C) Compendium, in an interview with 

You Don't Need to Be a GN Specialist to Identify Glomerular Disease Earlier

For more on the ASN's new GD-C Compendium itself and our conversation with George Vasquez-Rios, MD: 

New ASN Compendium Tackles Fragmented GN Care, With Vasquez-Rios, MD

When Should Glomerular Disease Be Suspected?

Vasquez-Rios pointed to unexplained proteinuria or hematuria, even when kidney function looks normal as a specific, actionable trigger for workup.

"Whenever we see patients that are dealing with proteinuria and/or hematuria, meaning blood in the urine, and we don't have a clear etiology, a clear answer why this is happening, this should prompt urinalysis, renal ultrasound, additional evaluations for considerations of a glomerular disease, even when the kidney function is relatively preserved," Vasquez-Rios said.

That distinction matters given how specialist access is distributed. Research published in the 

Journal of the American Society of Nephrology

 in July 2025 found that patients managed only by general nephrologists, without access to a glomerular disease specialist, were less likely to receive a kidney biopsy or newer therapies, a gap the authors linked to delayed diagnosis and treatment.² 

Earlier recognition during the point of entry to care with the clinicians patients actually see first, in Vasquez-Rios's view, is one way to narrow that gap before geography or specialist availability becomes the limiting factor.

Vasquez-Rios framed reaching out to more experienced colleagues as a normal part of managing an evolving field, not a sign of a gap in a clinician's own knowledge.

"There is no shame and there is no problem with calling other folks with more experience to ask for advice or support. I see that happening all the time, and I think that's where we as a community need to work together to create that level of bidirectional discussions," Vasquez-Rios said.

He also noted that access barriers don't stop at referral. Prescribing decisions for newer glomerular disease therapies carry their own friction, from prior authorization to documentation, which is part of why the ASN's GD-C compendium built out a dedicated recognition-to-referral pathway alongside practical guidance on navigating access issues.

A Community Clinicians Don't Have to Navigate Alone

Vasquez-Rios's closing point was that clinicians managing glomerular disease patients don't have to do it in isolation.

"Nobody has to do this alone. We are a community," Vasquez-Rios said. He pointed to ASN's online communities, where complex cases, including acute kidney injury and 

 with or without glomerular disease involvement, are discussed regularly, along with planned efforts like journal clubs and interviews addressing specific clinical questions. 

"I swing by every now and then," he said. "We are all together in this, and we can really make it better for our patients."

Editor's Note: Vasquez-Rios reports no relevant disclosures.

Monk B, Ewert B, Bomback AS, Gibson KL. Barriers to Patients Accessing Specialized Treatments for Glomerular Diseases. 

American Society of Nephrology. Glomerular Diseases Collaborative (GD-C) Compendium. Accessed September 17, 2026. 

https://epc.asn-online.org/projects/gd-c/

George Vasquez-Rios, MD explains the barriers in GN care that ASN's new compendium may address.

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A new ASN compendium curates scattered GN care guidance into one living resource, says nephrologist George Vasquez-Rios, MD

Anjali Owens, MD, discusses the long-term extension of the EXPLORER-HCM trial, demonstrating mavacamten’s safety and efficacy up to 5 years after initiation.

Cardiomyopathy

Mavacamten’s Improvements in oHCM Symptoms Sustained in Long-Term Extension

Josh D. Woolley, MD, PhD, professor of psychiatry and behavioral sciences, University of California, San Francisco.

In his paper, Josh D. Woolley, MD, PhD, proposes multidrug active placebos and limited disclosure to finally mask high-dose psilocybin trials.

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Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

PTSD

UMBRAA Framework Aims to Fix Blinding Failures in Psychedelic Trials

Where does Ameluz PDT fit next to Mohs surgery for skin cancer? Neal Bhatia, MD, on candidacy, adoption, and open questions.

Where Does Ameluz PDT Fit Alongside Mohs Surgery?

Chelsie Derman is an associate editor for 

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

The resubmission follows an FDA Complete Response Letter and cites human factors data showing pouch-opening time fell from 17 to 3 seconds.

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.

Anaphylaxis

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

Aquestive Resubmits Anaphylm NDA for Anaphylaxis Treatment

Characteristic clinical and radiographic findings can establish early suspicion for achondroplasia, while molecular and prenatal testing are helping clinicians confirm the diagnosis sooner.

Video Series

Peer Exchange

HCPLive® Peer Exchange panel discussions feature authoritative insights, opinions, and perspectives on important issues facing today's care professionals.

Recognizing and Diagnosing Achondroplasia

Achondroplasia is driven by overactive FGFR3 signaling that disrupts normal growth plate function. The panel explains how this molecular pathway affects endochondral bone growth and provides the foundation for understanding targeted treatment.

Understanding the Pathophysiology of Achondroplasia

In EMPA-KIDNEY, empagliflozin cut urinary uromodulin 63% without signs of tubular injury, reshaping views on SGLT2 inhibitor mechanisms.

Uromodulin Drop Offers Clues to SGLT2 Kidney Protection, With Greco Malijan, MD

Abigail Brooks is a strategic content lead overseeing 

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 approval, backed by FINE-ONE data showing a 28% UACR reduction at 6 months, is the first new CKD treatment for this group in 3 decades.

FDA News

Chronic Kidney Disease

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This page also hosts content previously published by EndocrinologyNetwork. 


Type 1 Diabetes

FDA Approves Finerenone (Kerendia) for CKD and Type 1 Diabetes

What does FDA approval of Ameluz PDT for superficial BCC mean for dermatology? Neal Bhatia, MD, weighs in on the first-of-its-kind decision.

Latest News

Q&A: What the First FDA-Approved PDT for Skin Cancer Means for sBCC Care

ERS Congress 2026: 6 Late-Breaking Trials to Know

STAT6 Degradation: A Novel Oral Target for Asthma?

Low-Voltage Zone Ablation After Pulmonary Vein Isolation Improves Rhythm Outcomes in AF

You Don't Need to Be a GN Specialist to Identify Glomerular Disease Earlier