HCPLive Editorial Staff

Welcome to The HCPFive, your go-to roundup for the latest healthcare news and breakthroughs, curated specifically for busy healthcare professionals.

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories include 

 approvals for maralixibat tablets and dupilumab—marking key advances in rare disease and allergy care. Positive trial data for orforglipron, combination lipid-lowering therapy, and aflibercept 8 mg also signal important shifts in how we treat diabetes, cardiovascular disease, and retinal conditions.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of April 13, 2025—let’s jump in!

Interested in oncology news? Check out The 

FDA Approves Maralixibat (Livmarli) Tablet for Alagille Syndrome, PFIC

On April 14, 2025, the FDA approved a new tablet formulation of Mirum Pharmaceuticals’ maralixibat (Livmarli) for the treatment of cholestatic pruritus in patients with Alagille syndrome (ALGS) and progressive familial intrahepatic cholestasis (PFIC). Maralixibat tablets are planned to be available in June through Mirum Access Plus, and the drug is being evaluated further in the phase 3 EXPAND study in additional settings of cholestatic pruritus.

Combination of Statins, Ezetimibe Could Prevent Thousands of Heart Attacks

Combination lipid-lowering therapy (LLT) with statins and ezetimibe could prevent thousands of further cardiovascular events among patients hospitalized with myocardial infarction (MI), according to new research from Lund University and Imperial College London. The adjusted hazard ratio of major adverse cardiovascular events (MACE) over 3 years was 1.14 for those receiving ezetimibe and 1.29 for those not receiving combination therapy.

FDA Accepts Aflibercept 8 mg for Priority Review to Treat Retinal Vein Occlusion

On April 17, 2025, the FDA accepted for Priority Review the supplemental Biologics License Application (sBLA) for aflibercept 8 mg (EYLEA HD) for the treatment of macular edema following retinal vein occlusion (RVO) and for monthly dosing in approved indications. An approval would establish aflibercept 8 mg as the first RVO treatment eligible for every 8-week dosing after an initial monthly period.

Oral GLP-1 Orforglipron Hits Target in Phase 3 Diabetes Trial

Topline results from ACHIEVE-1 reported oral orforglipron as effective and safe for adults with type 2 diabetes (T2D) inadequately controlled by diet and exercise. Eli Lilly and Company’s once-daily glucagon-like peptide-1 (GLP-1) receptor agonist achieved statistically significant reductions in hemoglobin A1c and body weight in the Phase 3 trial, and its safety profile remained consistent with the injectable therapies from the drug class.

FDA Approves Dupilumab (Dupixent) for Chronic Spontaneous Urticaria

On April 18, 2025, the FDA approved dupilumab (Dupixent) for the treatment of patients aged 12 years and older with chronic spontaneous urticaria (CSU) for whom CSU is uncontrolled with H1-antihistamines. The approval, marking the first new targeted therapy in more than a decade for CSU, was based the Phase 3 LIBERTY-CSU CUPID Study A and Study C trials.

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The recent FDA approvals of maralixibat tablets for Alagille syndrome and PFIC, and dupilumab for chronic spontaneous urticaria, represent significant advancements in rare disease and allergy care. Additionally, the combination of statins and ezetimibe shows promise in reducing cardiovascular events post-myocardial infarction. Aflibercept 8 mg is under Priority Review for retinal vein occlusion, potentially offering extended dosing intervals. Orforglipron, an oral GLP-1 receptor agonist, demonstrated efficacy and safety in a Phase 3 trial for type 2 diabetes, indicating a potential shift in diabetes management.

Our top 5 headlines spotlight FDA approvals for maralixibat and dupilumab, plus key trial results in diabetes, cardiovascular disease, and retinal vein occlusion.

The HCPFive: Top News for Healthcare Providers from the Week of 04/13

 affects approximately 10 to 20% of children and up to 10% of adults worldwide, with many experiencing moderate-to-severe disease with a significant impact on quality of life. Despite its prevalence, effective treatment options have historically been limited, particularly for patients who do not respond to topical corticosteroids or conventional systemic therapies. Until recently, therapeutic advancements have been slow, leaving many patients with persistent symptoms and few alternatives.

However, in 2024 alone, 4 therapies—tapinarof cream 1% (Vtama), nemolizumab (Nemluvio), roflumilast cream (Zoryve), and lebrikizumab (Ebglyss)—received approvals for atopic dermatitis in different populations, marking a significant expansion of available treatment options.

On December 16, 2024, the US Food and Drug Administration (FDA) 

 for an additional indication of the topical treatment of atopic dermatitis in adults and pediatric patients 2 years of age and older. This approval was based on positive results from the ADORING clinical program. In the phase 3 ADORING 1 and 2 trials, use of tapinarof was associated with a statistically significant difference versus vehicle in the proportion of patients achieving a score of clear (0) or almost clear (1) and a minimum 2-grade improvement from baseline at week 8 on the Validated Investigator Global Assessment for AD, with this achieved by 45.4% of the tapinarof group versus 13.9% of placebo patients in ADORING 1 and 46.4% versus 18.0% in ADORING 2, respectively (both 

This quiz is 4 of 4 in a series designed to reinforce knowledge of the data supporting these new treatments. By engaging with these quizzes, clinicians can better understand how these therapies fit into clinical practice and improve patient outcomes.

Interested in dermatology? Learn more about the annual Revolutionizing Atopic Dermatitis (RAD) Conference, hosted by 

, and our CE/CME partner Physicians’ Education Resource.

Test your knowledge below on data from the long-term extension trial, ADORING 3, and stay up to date with the latest clinical advancements in atopic dermatitis treatment:

Laughter MR, Maymone MBC, Mashayekhi S, et al. The global burden of atopic dermatitis: lessons from the Global Burden of Disease Study 1990-2017. Br J Dermatol. 2021;184(2):304-309. doi:10.1111/bjd.19580.

Choragudi S, Yosipovitch G. Trends in the Prevalence of Eczema Among US Children by Age, Sex, Race, and Ethnicity From 1997 to 2018. JAMA Dermatol. 2023;159(4):454-456. doi:10.1001/jamadermatol.2022.6647.

Organon. FDA approves VTAMA® (tapinarof) cream, 1% for the treatment of atopic dermatitis in adults and children 2 years of age and older. Organon. December 16, 2024. Accessed March 25, 2025. https://www.organon.com/news/fda-approves-vtama-tapinarof-cream-1-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-2-years-of-age-and-older/.

Galderma. Galderma receives U.S. FDA approval for Nemluvio® (Nemolizumab) for patients with moderate-to-severe atopic dermatitis. Galderma. December 14, 2024. Accessed March 25, 2025. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic.

Arcutis Biotherapeutics. FDA approves Arcutis’ ZORYVE® (roflumilast) cream 0.15% for the treatment of atopic dermatitis in adults and children down to 6 years of age. Arcutis Biotherapeutics. July 9, 2024. Accessed March 25, 2025. https://www.arcutis.com/fda-approves-arcutis-zoryve-roflumilast-cream-0-15-for-the-treatment-of-atopic-dermatitis-in-adults-and-children-down-to-6-years-of-age/.

Eli Lilly and Company. FDA approves Lilly’s EBGLYSSTM (lebrikizumab-lbkz) for adults and children 12 years and older with moderate-to-severe atopic dermatitis. Eli Lilly and Company. September 13, 2024. Accessed March 25, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglysstm-lebrikizumab-lbkz-adults-and.

Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: Significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. J Am Acad Dermatol. 2024;91(3):457-465. doi:10.1016/j.jaad.2024.05.023. 

Recent advancements in atopic dermatitis treatment have significantly expanded therapeutic options, particularly for patients unresponsive to traditional therapies. In 2024, four new therapies—tapinarof cream, nemolizumab, roflumilast cream, and lebrikizumab—received FDA approval, offering new hope for patients with moderate-to-severe disease. Tapinarof cream, approved for patients aged 2 and older, demonstrated significant efficacy in phase 3 trials, with a notable proportion of patients achieving clear or almost clear skin. These developments underscore the importance of staying informed about emerging treatments to enhance patient outcomes.

Test your knowledge below on pooled data from the ADORING trial program and stay up to date with clinical advancements in atopic dermatitis.

Clinical Quiz: ADORING Trial and Tapinarof Cream for Atopic Dermatitis

Welcome to HCPLive's 5 Stories in Under 5—your quick, must-know recap of the top 5 healthcare stories from the past week, all in under 5 minutes. Stay informed, stay ahead, and let’s dive into the latest updates impacting clinicians and healthcare providers like you!

Interested in a more traditional, text rundown? 

Top 5 Healthcare Headlines for March 31-April 6, 2025:

Cedars-Sinai Study Finds AI Tool Could Improve Care in Virtual Urgent Care Settings


A Cedars-Sinai study suggests AI tools may enhance guideline adherence and decision-making quality in virtual urgent care, though clinician oversight remains essential.



FDA Accepts Biologics License Application for ONS-5010 for Wet AMD


The FDA has accepted a resubmitted BLA for ONS-5010, a proposed ophthalmic formulation of bevacizumab for wet AMD, advancing it toward potential approval.



Socioeconomic Status Impacts Pediatric Preemptive Kidney Transplant Rates, Study Finds


A retrospective study linked lower socioeconomic status to reduced access to preemptive kidney transplants in pediatric patients, underscoring ongoing disparities in care.




The FDA has cleared the Dexcom G7 CGM system for 15-day use in adults, offering extended wear and continued improvements in diabetes monitoring technology.



Icotrokinra Clears Skin Among 75% of Adolescents with Plaque Psoriasis


New phase 3 data show once-daily icotrokinra improves skin clearance and maintains a favorable safety profile in adolescents with moderate-to-severe plaque psoriasis.

Recent advancements in healthcare include a Cedars-Sinai study indicating AI tools can enhance virtual urgent care, though clinician oversight is crucial. The FDA has accepted a BLA for ONS-5010, a bevacizumab formulation for wet AMD, and cleared the Dexcom G7 CGM system for extended use. A study highlights socioeconomic disparities in pediatric preemptive kidney transplants. Additionally, phase 3 data reveal icotrokinra's efficacy in improving skin clearance in adolescents with plaque psoriasis, maintaining a favorable safety profile.

An audio recap of the top 5 stories in healthcare news from the week of 03/31-04/06.



HCPLive 5 Stories in Under 5: Week of 04/06

Each week, we highlight 5 key developments or headlines from healthcare that you need to know—whether it's a cutting-edge treatment, regulatory updates, or innovations shaping the future of medicine. This week's top stories included new insights into artificial intelligence (AI) use in virtual care, a 

 update on a treatment for vision loss, a study examining disparities in pediatric kidney transplants, a clearance for a next-gen glucose monitoring system, and promising results from a psoriasis treatment trial.

With The HCPFive, you'll get the essential takeaways to stay informed and ahead of the curve. Here’s your quick dive into the top stories for the week of April 6, 2025—let’s jump in!

A new study from Cedars-Sinai found the use of artificial intelligence in virtual visits could improve decision-making and adherence to guideline-directed care in virtual urgent care settings. Recommendations from AI tools were more often rated as of better quality when AI and physicians differed, particularly in identifying opportunities to support guideline-adherent care. However, physicians were better at adapting recommendations to changing information during consultations.

The FDA accepted Outlook Therapeutics' resubmitted Biologics License Application (BLA) for ONS-5010 for the treatment of wet age-related macular degeneration. The regulatory agency has flagged the BLA as a Class 2 review, setting a Prescription Drug User Fee Act (PDUFA) target goal date of August 27, 2025, for the ophthalmic form of bevacizumab.

Guidelines from Kidney Disease: Improving Global Outcomes (KDIGO) recommend preemptive transplantation for all children with advanced chronic kidney disease. In 2021, only a quarter of children with incident ESKD received a preemptive transplant in the United States.

Leveraging data for kidney transplant recipients at the University of Minnesota, a recent retrospective study found lower socioeconomic index quartiles were linked to significantly reduced odds of preemptive transplantation.

The FDA awarded clearance to the Dexcom G7 15-day continuous glucose monitoring (CGM) system for individuals aged 18 years and older with diabetes. Building on the well-established Dexcom CGM platform, Dexcom’s G7 now boasts 15.5 days of wear and best-in-class accuracy with a mean absolute relative difference (MARD) of 8.0%.

A subgroup analysis of the Phase 3 ICONIC-LEAD randomized controlled trial found adolescents with moderate-to-severe plaque psoriasis treated with once-daily icotrokinra (JNJ-2113) attained higher rates of clear or almost clear skin at 16 weeks, compared with placebo. Icotrokinra demonstrated a favorable safety profile, achieving lower rates of adverse events (50% vs. 73%) than placebo, with no new safety signals reported.

Recent healthcare developments include AI's potential to enhance virtual urgent care, FDA's acceptance of a BLA for ONS-5010 targeting wet AMD, and socioeconomic disparities affecting pediatric kidney transplants. The FDA cleared the Dexcom G7 CGM system, offering extended wear and improved accuracy. Promising results emerged from a psoriasis treatment trial, with icotrokinra showing significant efficacy and safety in adolescents. These advancements highlight the ongoing evolution in medical technology, regulatory progress, and the importance of addressing healthcare disparities.

Our top 5 headlines spotlight developments in AI-driven care, diabetes tech, and dermatology, alongside key FDA actions in ophthalmology and nephrology.