How Does the FDA Approval of Risankizumab Impact Pediatric Psoriasis and PsA? With Amy Paller, MD

US Food and Drug Administration (FDA) approval

 of risankizumab-rzaa (Skyrizi) was announced for pediatric patients aged 6 years and older with moderate to severe 

Risankizumab expands biologic treatment options for children aged 6 years and older with plaque psoriasis and psoriatic arthritis.

Every-12-week maintenance dosing may reduce treatment burden for pediatric patients and caregivers.

The new weight-based prefilled syringe simplifies dosing for children weighing less than 40 kg.

 team, Amy Paller, MD, professor and chair of the Department of Dermatology at Northwestern University Feinberg School of Medicine, discussed the recent decision and the clinical significance of the expanded indication for dermatology clinicians treating children with inflammatory skin disease. Speaking with 

, Paller described the approval as an important addition to the pediatric psoriasis medication landscape, citing the drug’s impressive efficacy noted among adult populations and its practical advantages for improving long-term disease management.

What Does Risankizumab’s New Age Indication Add to the Psoriasis Landscape?

“We're very excited because of the fact that this is one of the best medicines out there for treating psoriasis, based on what we've seen in adults, and it also has an every 12-week administration, which is the favored frequency of administration by pediatric dermatologists and one of the reasons we've used so much ustekinumab,” Paller expressed.

Paller pointed to 1 of risankizumab's distinguishing characteristics as being its every-12-week maintenance dosing schedule. According to Paller, the interval is among the most desirable administration frequencies of treatment for pediatric dermatologists as it diminishes the number of injections needed by young patients throughout the year while maintaining their disease control. Such an approach, she noted, may help lessen treatment burden for patients and caregivers as opposed to drugs requiring more frequent administration.

How Are Psoriatic Disease Goals Shifting as New Options Emerge?

The expanded approval, she stated, also adds another highly effective biologic agent to an increasingly robust therapeutic armamentarium for pediatric psoriasis. While clinicians now have multiple biologic options available, Paller described treatment goals as having evolved beyond attaining partial disease improvement. She pointed to data demonstrating children who attain Psoriasis Area and Severity Index (PASI) 90 or PASI 100 responses experience greater improvements in quality of life than those achieving PASI 75, reinforcing the importance of pursuing near-complete or complete skin clearance whenever possible. Risankizumab, she noted, has demonstrated the ability to help many children attain those higher response thresholds.

Later in her discussion, Paller highlighted the value of risankizumab’s new weight-based dosing option for children. The availability of a 55-mg prefilled syringe for children weighing less than 40 kg simplifies the dosing schedule by eliminating the need for individualized dose preparation. She also described prefilled syringes as generally preferred for younger pediatric patients.

Beyond plaque psoriasis, Paller noted that the expanded indication for pediatric PsA also strengthens risankizumab's role in clinical practice. The expansion may allow clinicians to select a single biologic capable of treating both skin and joint manifestations when appropriate. As expectations for treatment continue to evolve, she described this combination of efficacy, convenience, and broad disease coverage as positioning risankizumab as an important new option.

Disclosures for Paller include the following: AbbVie, AnaptysBio, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Regeneron Pharmaceuticals, Inc., Sanofi – investigator; AbbVie, Amgen, Asana, Dermavant, Dermira, Eli Lilly, Forte, Galderma, LEO Pharma, Matrisys Bioscience, Menlo Therapeutics, MorphoSys/Galapagos, Novartis, Pfizer, Regeneron Pharmaceuticals. Inc., Sanofi – consultant.

Johnson V. FDA Approves Risankizumab for Pediatric Plaque Psoriasis, Psoriatic Arthritis. HCPLive. June 29, 2026. Accessed July 21, 2026. 

https://www.hcplive.com/view/fda-approves-risankizumab-pediatric-plaque-psoriasis-psoriatic-arthritis

AbbVie. SKYRIZI® (risankizumab-rzaa) now FDA approved for pediatric use in psoriatic disease. PRNewswire. Published June 26, 2026. Accessed July 21, 2026. 

https://www.prnewswire.com/news-releases/skyrizi-risankizumab-rzaa-now-fda-approved-for-pediatric-use-in-psoriatic-disease-302812335.html

Videos

Amy Paller, MD, highlights takeaways from the recent FDA approval of risankizumab-rzaa (Skyrizi) for children with psoriasis and PsA.

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.

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Ron Blankstein, MD, is the associate director of the cardiovascular imaging program, director of cardiac computed tomography, and co-director of the cardiovascular imaging training program at Brigham and Women’s Hospital, as well as a professor of medicine at Harvard Medical School.

AI-CPA Plaque Assessment Results Consistent, Reproducible Among Observers

Inter-observer and intra-observer results of AI-informed coronary computed tomography angiography (CCTA) derived 

 volume quantification (AI-CPA) are consistent with limited variation, indicating potential reproducibility, according to a recent study.

Presented at the 21st Annual Scientific Meeting of the Society for Cardiovascular Computed Tomography (SCCT) in San Diego, California, by Biyanka Jaltotage, MD, a cardiologist at Fiona Stanley Hospital, the present study sought to optimize quantification of coronary plaque volume, given its potential to aid in monitoring disease progression and assessing the effectiveness of given therapies.

“Reproducible results are important because we are now applying plaque analysis in patient management decisions and some clinical trials,” Ron Blankstein, MD, the associate director of the cardiovascular imaging program, director of cardiac computed tomography, and co-director of the cardiovascular imaging training program at Brigham and Women’s Hospital, as well as a professor of medicine at Harvard Medical School, told 

 in an exclusive interview. “We may, in the future, also think about the concept of comparing the amount of plaque for a particular person over time, perhaps to see if a treatment response is occurring. And for all those concepts, having a reproducible measure is really important.”

Jaltotage and colleagues enrolled patients from an on-label, post-market, multi-center, retrospective registry, with the intra- and inter-observer variation of 27 CCTAs assessed for AI-CPA. Each CCTA was analyzed 3 times each by 3 operators in a blinded setting. The coefficient of variation was used to compare relative variability across multiple measurements for inter- and intra-reader variability. Fleiss’ kappa was also assessed for agreement of the 243 total analyses to categorize patients into total plaque volume (TPV) stages – 0, 1-100, 101-250, 251-750, and ≥751.

A total of 27 participants were enrolled in the study, among whom the mean age was 61 +/- 10 years and 63% were males. Mean body mass index was 27.8 +/- 4.6, and 64% of patients had obstructive coronary artery disease, defined as ≥50% stenosis.

Jaltotage and colleagues computed plaque volume and compared it across the 243 independent AI-CPA analyses. The median value of TPV was 295 mm3 (interquartile range [IQR], 137-450), median calcified plaque volume (CPV) was 25 mm3 (IQR, 3-112), median noncalcified plaque volume (NCPV) was 238 mm3 (IQR, 124-384), and median low attenuation plaque volume (LAPV) was 0 (IQR, 0-0).

Interobserver variability for TPV, CPV, and NCPV was 3.1%, 5.7%, and 3.9%, respectively. Investigators cited this as excellent consistency between each reader. Intra-observer quantification of TPV, CPV, and NCPV was 5.3%, 6.4%, and 5.9%, respectively, indicating good intra-reader reproducibility through each measurement. Fleiss’ kappa for agreement among the 243 analyses to categorize patients into TPV stages was 0.95.

Ultimately, Jaltotage and colleagues concluded that these data indicate excellent inter-reader and intra-reader agreement and consistency across all 243 analyses with AI-CPA. While these results are positive, Blankstein also noted further research that he believes must be done before implementation.

“The other thing is to see whether changes in plaque over time are predicted. There’s certainly some data suggesting that, but we need more data in that space to tell us that if we know that plaque is progressing, that’s a higher risk patient,” Blankstein said. “On the other hand, if we know that the plaque is stable and not progressing, we need to know that that’s a lower risk phenotype.”

Editors’ Note: Blankstein reports disclosures with Amgen, Heartflow, Nanox AI, Novartis, Caristo Diagnostics, Siemens, and others.

Mengesha B, Jaltotage B, Fonte T, et al. Reproducibility of AI-Informed Coronary Computed Tomography Angiography-Derived Coronary Plaque Volume Quantification. Abstract presented at the 21st Annual Scientific Meeting of the Society of Cardiovascular Computed Tomography (SCCT), San Diego, CA. July 9-12, 2026.

Ron Blankstein, MD, discusses a recent study confirming the replicability of CCTA results with AI-CPA in patients with coronary plaque at risk of cardiovascular disease.

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...

Atherosclerotic Cardiovascular Disease

Medical director, pediatric hematology/oncology, Sarah Cannon Pediatric Transplant and Cellular Therapy Program, TriStar Centennial, and investigator, Sarah Cannon Research Institute

What Clinicians Should Discuss Before Exa-cel Gene Therapy

Following the US Food and Drug Administration (FDA)’s expanded approval of exagamglogene autotemcel (exa-cel; Casgevy) for children ≥2 years of age with sickle cell disease (SCD) and recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β-thalassemia (TDT), the next challenge will be helping patients and families understand what undergoing gene therapy actually entails.

“I think we need to be more thoughtful about explaining the gene therapy journey, what I call it, because it's truly a journey,” Haydar Frangoul, MD, MS, director of the pediatric stem cell transplant program at Sarah Cannon Research Institute and TriStar Centennial Children’s Hospital and first author of multiple landmark exa-cel studies told 

Unlike an allogeneic bone marrow transplant, where a donor provides stem cells for a recipient, exa-cel uses a patient’s own hematopoietic stem cells that are collected, genetically modified, and returned after treatment.

“The therapy is long, so unlike a bone marrow transplant, when you have a donor and you have a recipient and you can bring them in, and you can do a transplant within few weeks,” explained Frangoul. “Here, you have to collect the cells, you have to manufacture them.”

The manufacturing process adds several steps before infusion, requiring patients and families to understand that treatment involves a longer timeline than traditional transplantation.

In the phase 3 pediatric studies supporting the expanded indication, children underwent collection of their own stem cells followed by ex vivo CRISPR/Cas9 editing and myeloablative conditioning with busulfan before receiving exa-cel.

How to Counsel Patients on Myeloablative Conditioning

Before receiving exa-cel, patients undergo myeloablative conditioning to prepare the bone marrow for the edited cells. For many individuals with SCD or TDT, this may be their first experience with intensive chemotherapy.

“Unlike our patients that we treat, for example, in the setting of cancer therapy, where they get a bone marrow transplant, they have received chemo, they have lost their hair, they have developed complications related to chemotherapy. Here, in this therapy, people with sickle cell disease and thalassemia have never received chemo.”

Frangoul emphasized that counseling should include both the immediate effects of chemotherapy and the temporary immune suppression associated with conditioning.

“The discussion should include the short-term side effect of chemotherapy, which includes the loss of your hair, the development of mouth sores, the immune suppression as far as decreasing the immune system.”

While exa-cel avoids risks associated with donor transplantation, including graft-versus-host disease and graft rejection, conditioning-related toxicities remain an important consideration. In the pediatric phase 3 study, all participants experienced ≥ 1 grade 3 or 4 adverse event. Two children with TDT developed severe veno-occlusive liver disease considered related to busulfan conditioning, including 1 death.

Beyond short-term toxicities, Frangoul highlighted fertility as one of the most important long-term considerations before beginning therapy.

“The big one is infertility. So there is a higher risk of infertility with using busulfan chemotherapy, and individuals, parents, and children and adults considering this therapy need to consider whether they would want to pursue fertility preservation before this therapy.”

Because exa-cel is now being considered for younger patients, including children and adolescents, fertility preservation discussions may become an increasingly important part of treatment planning.

For clinicians, these conversations provide an opportunity to help families weigh the potential benefits of gene therapy alongside the risks and practical considerations involved in undergoing treatment.

Editor’s Note: Frangoul reports relevant disclosures with Vertex Pharmaceuticals, Editas Medicine, Rocket Pharmaceuticals, and others. 

FDA approves first gene therapy fsor young children with sickle cell disease.

Frangoul H, Locatelli F, Sharma A, et al. Exagamglogene autotemcel for severe sickle cell disease. 

 2024;390(18):1649-1662. doi:10.1056/NEJMoa2309676.

Frangoul H, et al. Exagamglogene autotemcel in children with severe sickle cell disease and transfusion-dependent β-thalassemia. 

Exa-cel requires careful counseling on treatment timelines, chemotherapy conditioning, fertility risks, and the gene therapy journey.

Hematology

Sickle Cell

Sickle Cell condition center page, resources on the topics of medical news and expert insight into sickle cell disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sickle cell research, treatment, and drug development.

FDA News

Counseling Patients On Exa-cel Gene Therapy Journey, With Haydar Frangoul, MD, MS

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.

 receiving long-term prophylaxis (LTP) who treated breakthrough attacks with oral sebetralstat achieved beginning of symptom relief in a median 1.3 hours, according to an interim analysis of the KONFIDENT-S open-label extension study, with effectiveness consistent regardless of which prophylactic agent patients were taking.¹

The prespecified analysis, published in the 

Journal of Allergy and Clinical Immunology: Global

, evaluated 35 participants with HAE due to C1-inhibitor deficiency (HAE-C1INH) who were receiving LTP with berotralstat (n = 16), lanadelumab (n = 13), or C1 inhibitor (C1INH) replacement (n = 6) while enrolled in the 2-year KONFIDENT-S extension of the phase 3 KONFIDENT trial.¹ Despite background prophylaxis, these participants experienced a mean ± standard deviation of 1.7 ± 1.5 breakthrough attacks per month and treated 382 of 504 total breakthrough attacks with on-demand sebetralstat 600 mg, the oral plasma kallikrein inhibitor approved by the US Food and Drug Administration (FDA) in July 2025 as the first oral on-demand HAE therapy, the second of 3 HAE treatments approved in successive months from June to August.¹⁻²

“In the span of just 3 months, there were 3 new treatment modalities approved in HAE, which is mind-blowing, really, but it's really a testament to all the work that's gone into [the field] in the last two decades. If we think back 16 years ago, that’s when the launch of modern-era medicine came out for hereditary angioedema and and to think of how far we’ve come in the treatment landscape just makes my other colleagues and other specialties envious of the advances that we have made,” Raffi Tachdjian, MD, MPH, from UCLA Health, previously told 

Investigators, led by Tamar Kinaciyan, MD, of the Medical University of Vienna, found that median time from attack recognition to sebetralstat administration was just 6 minutes (interquartile range [IQR], 1-40), a finding the authors attributed to the study's protocol-driven instruction to treat as early as possible.¹ Nearly 30% of attacks were treated while still mild. Median time to reduction in attack severity was 4.2 hours (IQR, 1.3 to >12), and median time to complete attack resolution was 14.8 hours (IQR, 4.6 to >24).¹ A post hoc analysis of time to end of attack progression, added after the primary effectiveness end points were defined, showed a median of 20.4 minutes, with 91% of sebetralstat-treated attacks reaching end of progression within 4 hours.¹

Effectiveness was broadly similar across attack severities, anatomic locations, and participant age groups, and did not differ meaningfully between participants on plasma kallikrein-inhibiting LTP (berotralstat or lanadelumab) and those on C1INH replacement.¹ Hazard ratios comparing participants receiving LTP with those receiving on-demand treatment alone were 1.38 (95% CI, 0.93-2.04) for time to symptom relief, 1.53 (95% CI, 0.98-2.40) for time to reduction in severity, and 1.75 (95% CI, 1.03-2.99) for time to complete resolution; investigators characterized effectiveness as "generally consistent" between the 2 groups, though these were unadjusted comparisons within a descriptive, open-label dataset rather than a powered statistical test.¹

A second sebetralstat dose was administered within 12 hours in 22.3% of attacks, and conventional injectable on-demand therapy was used as rescue in only 5.2% of sebetralstat-treated attacks, suggesting a single oral dose was sufficient for most breakthrough episodes.¹ Angioedema Quality of Life (AE-QoL) scores trended toward improvement through month 15, with a least squares mean change from baseline of -10.3 (95% CI, -21.1 to 0.6) — a confidence interval that crosses the null, meaning the improvement did not reach statistical significance at that time point.¹ Treatment satisfaction was high: participants reported being satisfied or better with sebetralstat for 88.8% of 276 rated attacks.¹

Safety was consistent with the drug's established profile. Of the 35 participants receiving LTP, 65.7% experienced a treatment-emergent adverse event (TEAE), and 14.3% experienced a TEAE considered treatment-related, most commonly headache, myalgia, arthralgia, nausea, or vomiting.¹ No serious or severe treatment-related TEAEs occurred. Two participants discontinued sebetralstat because of adverse events — 1 for a TEAE later attributed to viral meningitis and hepatotoxic comedications rather than sebetralstat, and 1 for nausea and vomiting during a mixed abdominal/laryngeal attack, in which gastrointestinal drug effects can be difficult to distinguish from attack symptoms.¹

The authors acknowledged several limitations relevant to interpreting the findings. The open-label design, while reflective of real-world use and permitting a larger attack sample than the randomized KONFIDENT trial, introduces potential reporting bias.¹ The analysis was descriptive and explicitly not powered to detect differences by LTP agent or across subgroups, and the C1INH replacement cohort was particularly small (n = 6), limiting how generalizable those findings are to that population.¹ The study was funded by KalVista Pharmaceuticals, sponsor and manufacturer of sebetralstat; several authors reported consulting fees, honoraria, or research support from the company, and 3 authors are former employees and shareholders while 3 others are current employees and shareholders.¹ Medical writing assistance was also funded by KalVista.¹

Sebetralstat's role alongside targeted LTP has drawn increasing clinical attention as HAE guidelines shift toward earlier, patient-controlled on-demand treatment regardless of background prophylaxis.³ The KONFIDENT-S data build on the smaller LTP subgroup from the original KONFIDENT trial, which included 24 participants receiving targeted LTP who treated 58 attacks, and now offer a considerably larger real-world-like dataset to inform how clinicians counsel patients who continue to break through on prophylaxis.¹⁻²

Kinaciyan T, Aygören-Pürsün E, Martinez-Saguer I, et al. Sebetralstat for breakthrough attacks in patients with hereditary angioedema receiving long-term prophylaxis in KONFIDENT-S. J Allergy Clin Immunol Global. 2026;5:100750. https://doi.org/10.1016/j.jacig.2026.100750

Riedl MA, Farkas H, Aygören-Pürsün E, et al. Oral sebetralstat for on-demand treatment of hereditary angioedema attacks. N Engl J Med. 2024;391:32-43. https://www.nejm.org/doi/10.1056/NEJMoa2314192

FDA Approves Sebetralstat for Hereditary Angioedema. AJMC. https://www.ajmc.com/view/fda-approves-sebetralstat-for-hereditary-angioedema

Articles

Interim KONFIDENT-S open-label extension data in HAE-C1INH patients on long-term prophylaxis (berotralstat, lanadelumab, or C1INH replacement) showed oral sebetralstat 600 mg provided rapid on-demand control of breakthrough attacks. Median time to symptom relief was 1.3 hours, with dosing occurring quickly after recognition (median 6 minutes). Median time to severity reduction and complete resolution were 4.2 and 14.8 hours, respectively, with broadly similar effectiveness across prophylaxis classes and subgroups. Safety reflected the established tolerability profile.

Interim KONFIDENT-S data show breakthrough HAE attacks began to be relieved at a median of 1.2 hours.

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.

Sebetralstat Shows Long Term Fast Relief of Breakthrough HAE Attacks

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.

has expanded the approved use of Ryaltris (olopatadine hydrochloride and mometasone furoate) nasal spray, 665 mcg/25 mcg per spray, to include the treatment of 

symptoms in children aged 6 to 11 years, Glenmark Pharmaceuticals announced July 21, 2026.

With the approval, Ryaltris is now indicated for adults and pediatric patients aged ≥ 6 years in the United States, broadening access to a younger population than the drug's original 2022 approval for patients aged ≥ 12 years.

Ryaltris combines olopatadine hydrochloride, an antihistamine, with mometasone furoate, a corticosteroid, in a single nasal spray formulation.

“This approval marks an important step in expanding access to Ryaltris in the United States,” said Marc Kikuchi, president & business head in North America, in a statement.

Phase 3 Trial Data Supporting Ryaltris Pediatric Approval

The expanded indication was supported by a phase 3, randomized, double-blind, placebo-controlled trial of 446 children aged 6 to 11 years with seasonal allergic rhinitis.¹ Investigators found that Ryaltris. delivered as 1 spray in each nostril twice daily, improved nasal symptoms compared with placebo and was well tolerated over the 14-day treatment period.

Seasonal allergies remain common among school-age children in the US. According to the Centers for Disease Control and Prevention, 25% of children aged 6 to 11 years were more likely to have a diagnosed seasonal allergy than children aged 0 to 5 years in 2024.

Ryaltris Safety Profile and Warnings for Pediatric Use

Ryaltris is contraindicated in patients with known hypersensitivity to its ingredients, including mometasone furoate. Warnings include risk of epistaxis, nasal ulcerations, septal perforation, and impaired wound healing.

The label also notes risks of hypersensitivity reactions, immunosuppression with worsening of existing infections, hypercorticism and adrenal suppression with misuse, and potential reduction in growth velocity in pediatric patients. The most common adverse reactions, occurring in at least 1% of patients, are dysgeusia, epistaxis, and nasal discomfort.

Glenmark Receives U.S. FDA Approval to Expand the Use of RYALTRIS® Nasal Spray for Children Aged 6 to Less Than 12 Years. Glenmark. Published July 21, 2026. Accessed July 21, 2026. 

https://innovacia.in/glenmark-receives-u-s-fda-approval-to-expand-ryaltris-use-for-children-aged-6-to-less-than-12-years/

Ryaltris FDA Approval History. Drugs.com. Published on January 20, 2022. Accessed on July 21, 2026. 

https://www.drugs.com/history/ryaltris.html

Prenner BM, Amar NJ, Hampel FC Jr, Caracta CF, Wu W. Efficacy and safety of GSP301 nasal spray in children aged 6 to 11 years with seasonal allergic rhinitis. 

National Center for Health Statistics. Diagnosed Allergic Conditions in Children Ages 0–17: United States, 2024. NCHS Data Brief No. 546. January 2026. 

https://www.cdc.gov/nchs/products/databriefs/db546.htm

The FDA expanded Ryaltris (olopatadine hydrochloride/mometasone furoate) nasal spray to treat seasonal allergic rhinitis in children aged 6–11 years, extending its US indication to patients aged ≥6 years. The fixed-dose antihistamine–intranasal corticosteroid combination was previously approved for ages ≥12 years. A phase 3 randomized, double-blind, placebo-controlled trial in 446 children showed twice-daily dosing (one spray per nostril) improved nasal symptoms versus placebo over 14 days with acceptable tolerability. Labeling emphasizes local nasal injury risks, infection-related precautions, and potential pediatric growth effects.

FDA expands RYALTRIS® approval to children aged 6 to 11 with seasonal allergic rhinitis, based on phase 3 trial data.

Seasonal Allergy

FDA Approves Ryaltris for Children Aged 6 to 11 With Seasonal Allergic Rhinitis

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.

Agios ends tebapivat development in sickle cell disease after phase 2 results show no differentiated benefit.

Agios Ends Tebapivat Development in Sickle Cell Disease After Phase 2

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.

According to a recent study, nearly 32.2% of US adults are well above their LDL-C targets to avoid atherosclerotic cardiovascular disease.

Dyslipidemia

New Dyslipidemia Guidelines Reveal Significant Gap in LDL-C and LLT Treatment Goals

After broadening eligibility criteria across several disease states and a wider age range, the new guidelines have made an estimated 87.5 million adults eligible for statins.

Millions of New Patients Eligible for Statins Under 2026 AHA/ACC Guidelines

Stay updated with the latest healthcare breakthroughs, including FDA approvals, phase 3 data, and open-label extension results.

Nephrology

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Dermatology

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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.

The HCPFive: Top News for Healthcare Providers from the Week of 07/12

John Sonnenberg, PhD, clinical psychologist, founder of Uptown Research Institute, and faculty at Northwestern University Feinberg School of Medicine.

John Sonnenberg, PhD, outlines EMERGE trial criteria, dosing sessions, and endpoints for DT120 (lysergide) ODT 100 µg in major depressive disorder.

Psychiatry

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Major Depressive Disorder

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Sonnenberg Breaks Down EMERGE Phase 3 Trial Design for DT120 in MDD

Haydar Frangoul, MD, discusses how the expanded indication may allow earlier conversations about curative therapy and intervention before irreversible complications develop.

FDA Expands Exa-Cel (Casgevy) Approval, Bringing Gene Therapy to Younger Children

Ron Blankstein, MD, discusses a secondary analysis of HeartFlow’s DECIDE registry, indicating undetected cardiovascular risk in patients previously labeled safe.

Total Plaque Volume Indicates Patients With 0 CAC May Still be at Risk

Kimberly Blumenthal, MD, discusses who qualifies for de-labeling and how risk stratification guides testing.

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.

Most Penicillin Allergy Labels Are Wrong, Blumenthal Says

Richard Lafayette, MD, is a professor of medicine and director of the Glomerular Disease Center at Stanford University Medical Center.

ORIGIN 3 investigator brings atacicept approval to BAFF/APRIL targeting to IgAN 

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.

Atacicept Approval Brings BAFF/APRIL Targeting to IgAN With Richard Lafayette, 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.

Newly published phase 2b RELIEVE UCCD data show strong 14 week results for duvakitug in ulcerative colitis and Crohn disease.

Gastroenterology

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

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Ulcerative Colitis

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Latest News

How Does the FDA Approval of Risankizumab Impact Pediatric Psoriasis and PsA? With Amy Paller, MD

AI-CPA Plaque Assessment Results Consistent, Reproducible Among Observers

Counseling Patients On Exa-cel Gene Therapy Journey, With Haydar Frangoul, MD, MS

Sebetralstat Shows Long Term Fast Relief of Breakthrough HAE Attacks

FDA Approves Ryaltris for Children Aged 6 to 11 With Seasonal Allergic Rhinitis