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

Efzofitimod did not significantly reduce the mean daily oral corticosteroid (OCS) dose after 48 weeks in people with 

 sarcoidosis although clinical benefits were observed. Accordingly, aTyr Pharma’s Phase 3 EFZO-FIT evaluating the therapy did not meet its primary endpoint.

“The results of EFZO-FIT™ demonstrate not only strong evidence of clinical efficacy for efzofitimod’s effect on quality of life and its capacity to facilitate steroid withdrawal, but also increased confidence that steroids overall can be reduced to manage symptoms and lung function without the fear of worsening disease,” principal investigator Daniel Culver, DO, Chair of the Department of Pulmonary Medicine at the Cleveland Clinic, said in a statement.

 “This trial represents an important step forward for the field, as it is by far the largest interventional study completed in sarcoidosis to date, demonstrating the feasibility of conducting a global multi-center randomized controlled trial. The findings provide valuable insights about the treatment of pulmonary sarcoidosis, which are likely to inform treatment practices in the future.”

EFZO-FIT was a global interventional study sarcoidosis that compared the efficacy and safety of efzofitimod at 3.0 mg/kg and 5.0 mg/kg doses versus placebo after 48 weeks of treatment in 268 patients with pulmonary sarcoidosis. The trial protocol included a guided steroid taper in the first 12 weeks of the study, followed by continued taper or rescue until week 48.

Study investigators found that the 5.0 mg/kg efzofitimod group had a mean reduction to 2.79 mg in mean daily OCS dose compared to 3.52 in the placebo group (

= .3313). All further statistical testing is reported as nominal findings as the study’s statistical analysis plan was designed on a hierarchical assessment basis.

Investigators did find a clinical improvement in the change from baseline on King’s Sarcoidosis Questionnaire (KSQ)-Lung score at week 48 for 5.0 mg/kg efzofitimod (10.36) compared to placebo (6.19; 

= .0479). Furthermore, 46.9% of patients on 5.0 mg/kg of efzofitimod achieved complete steroid withdrawal with stable KSQ-Lung score compared to 35.7% on placebo (

Furthermore, patients who achieved complete steroid withdrawal at week 48 with 5.0 mg/kg efzofitimod had greater improvements in KSQ-Lung compared to placebo (

= .0199). Overall, 52.6% of patients treated with 5.0 mg/kg efzofitimod achieved complete steroid withdrawal compared with 40.2% on placebo (

Forced vital capacity (FVC) values at week 48 were maintained.The change from baseline in absolute percent predicted FVC was -1.81 for patients in the 5.0 mg/kg efzofitimod group compared to 2.11 in the placebo group (

“This study demonstrates that patients with chronic, symptomatic sarcoidosis can be managed with substantially lower steroid doses than previously thought. In spite of a higher than anticipated placebo response, we found that treatment with efzofitimod was associated with a greater amount of steroid reduction and an improvement in the KSQ-Lung score,” Sanjay S. Shukla, MD, MS, President and Chief Executive Officer of aTyr Pharma, added.

 “These consistent findings suggest that treatment with efzofitimod may positively impact quality of life and preserve lung function while reducing steroid burden, providing a meaningful benefit to patients. We look forward to discussing the totality of the data with the FDA in order to determine the path forward for efzofitimod in pulmonary sarcoidosis, as there remains an urgent need for a safe and effective treatment option to address the unmet needs of this underserved population.”

Efzofitimod was generally well-tolerated at both the 3.0 mg/kg and 5.0 mg/kg doses, with a safety profile consistent with that seen in other trials of the therapy. Further data on efzofitimod will be presented at the upcoming European Respiratory Society Congress on September 30, in Amsterdam, Netherlands. aTyr Pharma plans to engage with the United States Food and Drug Administration (FDA) to review the data and determine the path forward for efzofitimod in pulmonary sarcoidosis.

In June 2025, aTyr Pharma announced positive early data in people with diffuse and limited 

systemic sclerosis-related interstitial lung disease

 (SSc-ILD) from the ongoing Phase 2 EFZO-CONNECT study. Investigators found that all patients had stable or improved modified Rodnan Skin Score (mRSS) and 3 of 4 evaluable, efzofitimod-treated patients with diffuse SSc-ILD had at least a 4-point improvement.

aTyr Pharma Announces Topline Results from Phase 3 EFZO-FIT™ Study of Efzofitimod in Pulmonary Sarcoidosis. News release. aTyr Pharma. September 15, 2025. 

https://finance.yahoo.com/news/atyr-pharma-announces-topline-results-113000869.html

Johnson V. Efzofitimod Shows Promising Early Efficacy in Systemic Sclerosis-Related Interstitial Lung Disease. Article. HCPLive. June 5, 2025. 

https://www.hcplive.com/view/efzofitimod-shows-promising-early-efficacy-in-systemic-sclerosis-related-interstitial-lung-disease

Articles

Efzofitimod did not significantly reduce the mean daily oral corticosteroid dose in pulmonary sarcoidosis patients after 48 weeks, failing to meet the primary endpoint of the Phase 3 EFZO-FIT study. However, clinical benefits were observed, including improved quality of life and steroid withdrawal facilitation. The study demonstrated the feasibility of conducting large-scale trials in sarcoidosis and provided insights into treatment practices. Efzofitimod was well-tolerated, and further data will be presented at the European Respiratory Society Congress. aTyr Pharma plans to discuss the findings with the FDA.

News

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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.

Clinical

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Efzofitimod Fails to Meet Primary End Point in Phase 3 Pulmonary Sarcoidosis Trial

Pankaj Arora, MD, is an associate professor of medicine at the University of Alabama at Birmingham.

COLLIGO-HCM: Mavacamten (CAMZYOS) Effective in Obstructive HCM With Pankaj Arora, MD

Results from the COLLIGO-HCM observational study have indicated the safety and efficacy of mavacamten (CAMZYOS) in patients with symptomatic 

obstructive hypertrophic cardiomyopathy (HCM)

, which is consistent with prior studies.

Mavacamten is the first and only cardiac myosin inhibitor approved by the US Food and Drug Administration for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM.

COLLIGO-HCM is part of a larger program by parent company Bristol Myers Squibb, titled Worldwide AnalYsis on eFfectiveness AcRoss divErse populations for Real-world mavacamten use in patients with Hypertrophic CardioMyopathy (WAYFARER-HCM), which currently spans 7 countries and includes >3000 patients. It aims to investigate the effectiveness and safety of mavacamten on a larger scale, across a variety of conditions.

COLLIGO-HCM, a global, retrospective data study, was presented at the European Society of Cardiology Congress 2025 in Madrid. The data indicated mavacamten’s association with reduced left ventricular outflow tract (LVOT) obstruction and improved symptom burden. The study also included a particularly racially diverse population (n = 278), including 23.2% Black, 5.4% Asian, and 4.3% Middle Eastern or North African patients.

A total of 59.9% of patients achieved ≥1 NYHA class improvement by week 24, and 86.5% of patients with ≥12 weeks of follow-up and 94.4% of those with ≥24 weeks of follow-up had an NYHA classification of II or below, including 30.9% who had an NYHA classification of I. These proportions increased consistently throughout week 96. Additionally, by week 36, 90.3% of patients achieved mean LVOT gradients of ≤30 mmHg at rest, and 76.8% after Valsalva provocation.

“COLLIGO challenges the one-size-fits-all approach, and it sort of broadens the scope of what should be second-line therapy and what should be first line,” Pankaj Arora, MD, said in an interview with 

. “Beta blockers and calcium channel blockers currently in the guidelines, they are first line, but when patients continue to have symptoms or elevated gradients, myosin innovation using mavacamten is being considered.”

During the follow-up period, mean left ventricular ejection fraction (LVEF) remained at or above 61% compared to a baseline value of 66%. Temporary interruption due to LVEF ≤50% occurred in 11 patients, and permanent discontinuation took place in 3 patients. New-onset atrial fibrillation was only recorded in 8 patients, which is consistent with previously reported data from other studies.

Most patients initiated mavacamten while also taking background medications, such as beta blockers or calcium channel blockers (n = 258). Of these, 26.4% discontinued ≥1 type of therapy, and 5% downtitrated their background medications after starting mavacamten. Arora highlighted this detail as a critical find, indicating potential room for further study.

Moreover, the nearly 60% of patients who improved ≥1 NYHA class highlight the potential for a paradigm shift in HCM treatment. Arora discussed what he views as an impending shift in the way clinicians and investigators will approach the disease and its effects.

“This is not just symptom management; it is functional restoration for these patients,” Arora told 

. “It’s time to recalibrate our scales, time to rethink what we define as successful therapy in obstructive HCM.”

Bristol Myers Squibb Presents Real-World Outcomes of Camzyos (mavacamten) Across Four Continents at the European Society of Cardiology (ESC) Congress 2025. Bristol Myers Squibb. August 29, 2025. Accessed September 15, 2025. 

https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Presents-Real-World-Outcomes-of-Camzyos-mavacamten-Across-Four-Continents-at-the-European-Society-of-Cardiology-ESC-Congress-2025/default.aspx

COLLIGO-HCM: A Multinational Observational Study of the Real-World Effectiveness of Mavacamten Among Patients with Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) (COLLIGO-HCM). ClinicalTrials.gov identifier: NCT06372457. Updated April 18, 2024. Accessed September 15, 2025. 

https://clinicaltrials.gov/study/NCT06372457?term=COLLIGO-HCM&rank=1

Videos

Arora discusses the results of Bristol Myers Squibb’s observational study and the implications it has for the study of obstructive HCM and cardiology at large.

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...

Cardiomyopathy

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 

Off-label dose escalation of 2 interleukin (IL)-17A inhibitors, secukinumab and ixekizumab, may improve outcomes in certain cases among patients with 

, but new findings suggest the benefits should be weighed against costs and risks.

These findings and others regarding off-label adjustments to using ixekizumab and secukinumab among individuals living with psoriasis resulted from a recent letter to the editor authored in part by Jashin J. Wu, MD, from the Department of Dermatology at the University of Miami Miller School of Medicine.

Wu and coauthors highlighted that despite the well-known efficacy of IL-17A inhibitors in treating moderate-to-severe plaque psoriasis, many individuals need off-label dosing adjustments. Such shifts can include reduction, escalation, or interruption of medications.

“To evaluate the efficacy and safety of such regimens, a search of PubMed, Cochrane Library, Ovid MEDLINE and Embase was conducted for randomized controlled trials published between January 1, 2014 and December 6, 2024, assessing off-label dosing regimens in adults with moderate-to-severe psoriasis,” the investigative team wrote.

The investigators noted that the escalation of biologic use is sometimes considered by clinicians to improve one's response in psoriasis, but evidence suggests this strategy should be implemented selectively. For secukinumab, dose intensification from every 4 weeks (Q4W) to every 2 weeks (Q2W) is not routinely advised unless those on the medication weigh ≥90 kg.

Among those showing only partial improvement in their disease (PASI ≥75 but <90), a shift to Q2W led to a modest 7%–10% PASI-90 rate increase compared with Q4W, though this difference did not reach statistical significance. In additional data highlighted by the team, patients ≥90 kg saw more substantial benefits as a result of this strategy.

Escalation of one's ixekizumab dose during maintenance was shown in additional findings highlighted by Wu et al to yield greater advantages, with PASI-90 being observed in 79.5% of those on Q2W dosing versus 65.2% on Q4W (

< .001). Other data explored by the investigators suggested that dose de-escalation strategies, aimed at drug cost reduction or side effect limits, carry the risk of diminished effectiveness among patients.

Specifically, the research team pointed to findings showing that among secukinumab-treated individuals who had already reached PASI ≥90, maintenance at Q4W preserved higher PASI-90 rates (85.7%) as opposed to Q6W (74.9%) by the 52-week mark (OR 1.91, 95% CI 1.44–2.55). Similarly, the team pointed to findings showing that extending dosing to Q12W led to a 35% reduction in sPGA 0/1 rates at the 60-week mark relative to Q4W.

In pooled analyses from the UNCOVER trials, data also suggested that during induction, sPGA 0/1 responses were more robust with Q2W dosing compared to Q4W at the 12-week mark (81.8% versus 75%, 

< .001). Although some maintained adequate disease control with the diminished dosing, overall patterns suggested that less frequent administration of this drug would compromise outcomes. As such, Wu and coauthors highlighted the importance of individualizing such decisions.

The investigators pointed to additional data indicating that continuous therapy generally provides the most stable disease control, adding that despite this conclusion, treatment interruption does not always lead to irreversible loss of efficacy. IL-17A inhibitors are known to have a moderate relapse timeline, allowing certain patients to remain clear for months without treatment. Although not all individuals with psoriasis regain their initial level of improvement, many do, supporting the feasibility of temporary treatment pauses when clinically necessary. Additional data was noted as necessary to clarify whether reintroducing loading doses at the time of re-treatment improves outcomes, as study designs have differed.

Lastly, Wu and colleagues highlighted the central concern of safety with both escalation and de-escalation. Notably, the investigative team pointed to the consistent dose-dependent increase in serious adverse events that was observed with secukinumab and ixekizumab. However, they added that prior data suggest common mild infections with higher dosing. Anti-drug antibodies (ADA) are another concern. The team noted that this may be impacted by treatment interruption. In secukinumab retreatment-as-needed studies, ADA formation took place in 2 subjects on continuous therapy and a single patient on intermittent therapy, with neutralizing antibodies (nAbs) observed in 1 patient from each cohort. In the ixekizumab UNCOVER-1 and -2 extension trials, investigators had observed ADA in 19% of individuals on continuous treatment and 22.5% of those retreated after interruption, with nAbs present in 2 subjects from the re-treatment cohort.

“This study is limited by cross-trial comparisons, restricted generalizability due to selective trial populations and analysis of dose adjustments in patients meeting prespecified responses,” the team concluded.

 “Brodalumab and bimekizumab were excluded to maintain focus, as including all IL-17 inhibitors would significantly broaden the review and reduce the depth of analysis.”

Kim D, Babaei N, Cervantes M, Wu JJ. Off-label biologic regimens of IL-17A inhibitors for psoriasis. J Eur Acad Dermatol Venereol. 

Reich K, Puig L, Orsenigo R, et al. Secukinumab dosing optimization in patients with moderate-to-severe plaque psoriasis: results from the randomized, open-label OPTIMISE study. Br J Dermatol. 2020 Feb;182(2):304-315. 

. Epub 2019 Sep 8. PMID: 31102257. Accessed September 15, 2025.

Off-label dose escalation of IL-17A inhibitors, secukinumab and ixekizumab, may enhance outcomes for psoriasis patients, but the benefits must be balanced against potential costs and risks. Dose intensification, particularly for patients weighing ≥90 kg, can improve response rates, though not always significantly. Escalation of ixekizumab during maintenance showed notable advantages, while de-escalation strategies risk reduced effectiveness. Continuous therapy generally offers stable disease control, though temporary treatment pauses may be feasible. Safety concerns include dose-dependent adverse events and anti-drug antibodies, necessitating careful consideration of individualized treatment plans.

This letter explores off-label dosing adjustments for patients with psoriasis using the IL-17A inhibitors secukinumab and ixekizumab.

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.

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.

Dose Escalation of IL-17A Inhibitors for Psoriasis Effective, Though Risks Remain

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.

On September 4, 2025, the US Food and Drug Administration (FDA) publicly released Lykos Therapeutics’ Complete Response Letter (CRL) on midomafetamine (MDMA) capsules for 

The FDA had initially issued a CRL on August 9, 2024, after its Psychopharmacologic Drugs Advisory Committee (PDAC) raised concerns on June 4, 2024, about safety, cardiovascular risks, and functional unblinding in trials.

 The committee noted that pivotal trials lacked systematic documentation of abuse-related adverse events, as required by the FDA, and provided insufficient data to guide clinicians on the duration of MDMA’s effect.

Other concerns included inconsistent therapy protocols, limited patient diversity, unclear separation of MDMA effects from psychotherapy, patient vulnerability due to acute impairment (i.e., impaired judgment), and inadequate therapist oversight.

The CRL, now public, lists 3 main concerns, 8 safety components, and 9 trial suggestions that do not affect approvability.

Failure to report positive or abuse potential adverse events.

The CRL noted that the study failed to collect important information deemed “positive” or “favorable” by participants, therapists, or investigators, and the FDA identified several unreported adverse events at multiple sites. Documenting such events is critical to assess abuse potential, as even seemingly positive experiences—like euphoria or mood changes—can signal risk.

The FDA also found inconsistencies between the MAPP2 protocol and the training/safety manual in defining adverse events. The manual excluded “positive or favorable effects,” while the protocol included any medical occurrence, whether related to the trial or not. The agency emphasized that all events relevant to abuse potential or impairment should have been reported.

2. Not evaluating MDMA’s durability beyond 18 weeks

The MAPP1 and MAPP2 trials did not test whether MDMA is durable beyond 18 weeks. Since PTSD is chronic, a durable benefit is required, especially given the proposed limited regimen of 3 treatment sessions.

The follow-up study (MPLONG) was inadequate due to design flaws: it had only 1 visit, variable timing (6 months–2 years), low enrollment with potential self-selection bias, and many participants received other therapies in the interim. As a result, the data do not establish whether MDMA’s benefits persist, if retreatment is needed, or how it should be managed long term—information essential for labeling and clinical use.

3. Selection bias with many participants having prior experience with MDMA

About 40% of participants had prior MDMA use, raising functional unblinding concerns. The FDA recommends a randomized, double-blind study excluding prior users, with pre-specified retreatment criteria, full adverse event reporting, and third-party data audit.

Detail any significant changes in the safety profile.

Present new safety data alongside original data, including adverse event frequencies for all indications and comparisons with prior reports.

Provide case report forms and narratives for participant deaths, discontinuations due to adverse events, and serious adverse events.

Highlight changes in common, less serious adverse events.

Update clinical study exposure information.

Summarize worldwide safety experience, including drug use in other countries.

Include English translations of current foreign labeling.

Other recommendations include routine labs (i.e. liver analytes, electrolytes) and vital signs, psychotherapy contribution (i.e. including an arm without psychotherapy), improving diversity, assessing MDMA-SSRI interactions, PK studies in hepatic/renal impairment, and lactation and pre-/post-natal studies.

“Lykos will continue negotiations with the FDA,” said MAPS Founder & President Rick Doblin in a statement.4 “MAPS will keep driving forward: incubating and accelerating new MDMA-focused research, training therapists…catalyzing humanitarian projects in high trauma/low resource areas of the world and building the infrastructure for a future where psychedelic-assisted healing and personal growth is not delayed by shifting politics but delivered as a matter of compassion and justice.”

Complete Response, NDA 215455. US Food and Drug Administration. August 8, 2024. Accessed September 15, 2025. 

https://psychedelicalpha.com/wp-content/uploads/2025/09/CRL_NDA215455_20240808.pdf

Derman C. FDA Rejects Application for MDMA-Assisted Therapy in PTSD, Calls for Additional Trial. 

. Published August 9, 2024. Accessed September 15, 2025. 

https://www.hcplive.com/view/fda-rejects-application-for-mdma-assisted-therapy-in-ptsd-calls-for-additional-trial

Kunzmann K. FDA Psychopharmacologic Advisory Committee Votes Against Supporting Effectiveness of MDMA for PTSD. HCP Live. Published June 4, 2024. 

https://www.hcplive.com/view/live-updates-fda-psychopharmacologic-advisory-committee-meeting-mdma-ptsd

MAPS Statement on FDA’s Public Release of Complete Response Letter for MDMA-assisted Therapy – Multidisciplinary Association for Psychedelic Studies – MAPS. Maps.org. Published September 5, 2025. Accessed September 15, 2025. 

https://maps.org/2025/09/04/fda-public-release-of-crl/

The FDA released a Complete Response Letter (CRL) for Lykos Therapeutics' MDMA capsules for PTSD, highlighting concerns about safety, trial design, and data reporting. Key issues include inadequate documentation of abuse-related adverse events, lack of data on MDMA's long-term efficacy, and selection bias due to prior MDMA use among participants. The CRL outlines three main concerns, eight safety components, and nine trial suggestions. Lykos plans to address these issues and continue negotiations with the FDA, while MAPS remains committed to advancing MDMA research and training therapists for future applications.

MDMA’s CRL, now available to the public, cites gaps in safety data, selection bias, and limited durability.

Psychiatry

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.

PTSD

FDA Releases CRL Detailing Safety Concerns for MDMA-Assisted Therapy in PTSD

Amy Stewart, NP, is a GI Nurse Practitioner at Capital Digestive Care.

Rectal examinations are a routine yet often underutilized component of physical assessment across a wide range of clinical settings. While they are frequently associated with prostate evaluation, particularly in men, their scope is much broader and extends to the detection of multiple anorectal conditions.

Despite their importance, many clinicians report limited training or discomfort with performing rectal exams, which can contribute to underuse and misinterpretation of findings, some of the most common of which include hemorrhoids, anal fissures, perianal abscesses, fistulas, and skin tags. Beyond these, rectal exams can also reveal more serious conditions such as anal cancer or precancerous lesions related to human papillomavirus (HPV).

When performed properly, rectal exams remain one of the most valuable bedside tools for differentiating between common and clinically significant anorectal disorders, as highlighted at the 

2025 Gastroenterology & Hepatology Advanced Practice Providers (GHAPP) conference

 by Amy Stewart, NP, a GI Nurse Practitioner at Capital Digestive Care.

For further insight into her session at GHAPP and some of the key takeaways for NPs and PAs, the editorial team of 

 spoke with Stewart for the following Q&A:

: What are the goals of and take home messages from this session?

: My fun titled topic is "Everything Anal: What's Going on Back There?"

I think in school for many of us NPs and PAs were taught how to do a very basic rectal exam, which usually focuses on the prostate. But that's not our goal of a rectal exam in practice, right? So in practice, we need to distinguish between hemorrhoids, fissures, abscesses, fistula, HPV, and anal cancer without anyone ever really teaching us how to do this exam.

My talk is about all of the different kinds of common anal rectal conditions that you see and how to clinically examine for them, what you need specifically to do on your exam, what you're looking for. It also includes a lot of pictures so people can really see what they might see in clinic. The goal is for participants to really leave that talk feeling much more confident about a rectal exam, which is a really key piece of our job as NPs and PAs.

: What are the most common misconceptions or misdiagnoses you see when it comes to rectal exams?

: So I would say in general, less so from GI APPs, but certainly from my colleagues who work in urgent care and primary care, if you don't do a lot of rectal exams, it can be hard to understand the pathology of what you're looking for. I see many skin tags that are treated as active hemorrhoids, and you can put all the steroid cream you want on a skin tag, but it's not going to change or go away. So a component of my talk is the difference between the two.

Anal fissures are also often really commonly misdiagnosed or missed on exam. You can see them, but you really have to get into all the nooks and crannies of that perianal skin in order to see them. There's a lot of really good clinical pearls, if you will, in what you're looking for and what you're going to see on exam.

: Are there any other key takeaways you would like to highlight?

: I think just some other things that sometimes GIs don't recognize as often is HPV. So looking for condylomas or pre-cancerous changes from HPV, as they also specialize in anal HPV, but also herpes lesions are often misdiagnosed as fissures too. So I also have some information about that, and really kind of the clinical picture of how that presents for people as well.

Villanueva Herrero JA, Abdussalam A, Kasi A. Rectal Exam. StatPearls. February 18, 2023. Accessed September 15, 2025. 

https://www.ncbi.nlm.nih.gov/books/NBK537356/ 

Stewart reviews clinical pearls for performing rectal exams and explains common mistakes and misdiagnoses as well as how to avoid them.

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.

Conference

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

Beyond the Prostate: Expanding the Role of the Rectal Exam With Amy Stewart, NP

An audio recap of the top 5 stories in healthcare news from the week of 9/5-9/13.

Focal Segmental Glomerulosclerosis

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

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.

Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Chronic Kidney Disease

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.

HCPLive 5 Stories in Under 5: Week of 09/07

Ann Moore, NP, is a nurse practitioner at Arizona Liver Health.

Moore discusses the importance of individualizing PBC treatment now that multiple second-line therapies are available.

Navigating New PBC Therapies and Treatment Monitoring With Ann Moore, NP

Real-world data show epinephrine nasal spray achieved an 89.2% success rate in treating anaphylaxis, nearly identical to the injection’s response rate.

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.

Epinephrine Nasal Spray Shows Comparable Efficacy to Injection, With Thomas Casale, MD

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.

The US Food and Drug Administration has approved bumetanide nasal spray for the treatment of edema in outpatient heart, liver, and kidney diseases.

FDA News

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.

FDA Approves Bumetanide Nasal Spray for Edema with Congestive Heart Failure

This episode highlights the challenges of navigating demanding medical careers while raising young children, with insights and practical strategies.

The Medical Sisterhood, with Mona Shahriari, MD

The Medical Sisterhood, hosted by Mona Shahriari, MD, is a podcast dedicated to empowering female physicians by providing a platform for shared experiences, mentorship, and support. 

Each episode delves into the unique challenges women in medicine face, including work-life balance, leadership roles, and overcoming gender biases. Shahriari aims to inspire women to lead fulfilling professional and personal lives on their own terms through candid discussions and expert interviews. 

e as we foster a community where women can uplift and support each other in achieving their goals!

Podcasts

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

The Medical Sisterhood: Calendars, Clinics, and Chaos, With Amy Chen, MD

Abigail Brooks is an assistant 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 label update expands the treatment eligible population to include dystrophic epidermolysis bullosa patients from birth and allows at-home application.

FDA Approves Beremagene Geperpavec-svdt (Vyjuvek) Label Update in DEB

New research from Stockholm, Sweden, has shown the correlation between smoking and insulin sensitivity, with genetic susceptibility increasing the risk further.

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.

Type 2 Diabetes

Smoking Increases Risk of All Type 2 Diabetes Subtypes

This review highlights several evidence-based approaches to promoting skin longevity and preventing signs of aging.

Alopecia

‘Skinspan’ Framework Developed to Extend Skin Longevity, Prevent Aging

Stay updated with the latest healthcare breakthroughs, including FDA news and the voluntary withdrawal of obeticholic acid, in this week's essential news roundup.

The HCPFive: Top News for Healthcare Providers from the Week of 09/07

Research shows reduced risk of death, major adverse cardiovascular events, and myocardial infarction, and a non-significant reduction in stroke and cardiovascular death.

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Efzofitimod Fails to Meet Primary End Point in Phase 3 Pulmonary Sarcoidosis Trial

COLLIGO-HCM: Mavacamten (CAMZYOS) Effective in Obstructive HCM With Pankaj Arora, MD

Dose Escalation of IL-17A Inhibitors for Psoriasis Effective, Though Risks Remain

FDA Releases CRL Detailing Safety Concerns for MDMA-Assisted Therapy in PTSD

Beyond the Prostate: Expanding the Role of the Rectal Exam With Amy Stewart, NP