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.

Another quiet month for the US Food and Drug Administration (FDA), February was bookended by topline and full results from several key trials in 

. A significant amount of research was conducted over the last 3 weeks, resulting in a slew of new treatments rapidly approaching phase 3, and potentially submissions to the FDA.

As we ramp up to a busy March for cardiology, the 

 editorial team has collected 5 of the most impactful headlines of February 2026 – catch up on any news you might have missed below.

FDA Accepts Olezarsen’s sNDA for Severe Hypertriglyceridemia, Grants Priority Review

On February 26, 2026, the FDA accepted a supplemental New Drug Application for olezarsen, granting it priority review for the treatment of severe hypertriglyceridemia (sHTG). The application was submitted after the success of CORE and CORE2, a pair of double-blind randomized phase 3 trials comparing olezarsen to placebo. The FDA has set a Prescription User Drug Fee Act (PDUFA) date of June 30, 2026.

TLC-2716 Achieves Primary Endpoints in Phase 2a Trial in Patients With SHTG and MASLD

TLC-2716, an oral, liver-targeted liver X receptor inverse agonist from OrsoBio, met its primary efficacy endpoint in patients with sHTG and metabolic dysfunction-associated steatotic liver disease (MASLD). This phase 2a trial also illustrated TLC-2716’s reductive effects across total cholesterol, non-HDL cholesterol, and VLDL cholesterol among 30 patients.

Abelacimab Reduces Bleeding in AF Consistently Across Age Groups, With Christian Ruff, MD

The AZALEA-TIMI 71 phase 2b trial highlighted the efficacy of abelacimab for reducing bleeding in patients with atrial fibrillation (AF) compared to rivaroxaban. Most notably, these data were consistent across all age groups, indicating the FXI inhibitor’s efficacy among elderly patients, who are at increased risk for bleeding. Abelacimab’s substantial reduction of bleeding events may also address the lingering issue of bleed fears among patients who have AF, circumventing the fact that roughly 50% of patients with AF are not on anticoagulants.

OCEANIC-STROKE: Asundexian Reduces Stroke Risk Without Increasing Bleeding, With Andrew Russman, DO

Asundexian, another factor FXI inhibitor, demonstrated its superiority to placebo in preventing ischemic stroke in patients who have already experienced a non-cardioembolic ischemic stroke or high-risk transient ischemic attack. These data from the pivotal phase 3 OCEANIC-STROKE trial highlighted a 26% reduction in ischemic stroke with no increase in risk of ISTH major bleeding, consistent across all subgroups.

CORALreef Lipids: Enlicitide Reduces LDL-C in Patients With ASCVD, With Ann Marie Navar, MD, PhD

Enlicitide decanoate has successfully demonstrated its efficacy in reducing LDL-C among patients with a history of or at risk for a 

major atherosclerotic cardiovascular disease (ASCVD)

 event. The oral macrocyclic peptide outperformed placebo, resulting in a mean LDL-C reduction of 57.1% versus placebo’s 3% mean increase.

Articles

February brought limited FDA action but notable cardiovascular trial readouts spanning dyslipidemia, thrombosis, and stroke prevention. The FDA accepted olezarsen’s sNDA for severe hypertriglyceridemia with priority review and a June 30, 2026 PDUFA date, supported by CORE/CORE2 phase 3 data. In early-stage metabolic disease, oral liver-targeted TLC-2716 lowered triglycerides and atherogenic lipoproteins in sHTG with MASLD. FXI inhibition advanced with abelacimab reducing bleeding versus rivaroxaban in AF and asundexian cutting recurrent ischemic stroke without excess major bleeding. Enlicitide decanoate achieved ~57% LDL-C reduction in ASCVD-risk patients.

Catch up with FDA decisions, key trial results, and more.

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5 Cardiology Headlines You Missed in February 2026

Vallerie McLaughlin, MD | Image Credit: University of Michigan Medical School

On March 2, 2026, United Therapeutics Corporation announced that its investigative prostacyclin (IP) receptor agonist ralinepag has met its primary endpoint of reducing worsening clinical events in patients with 

Ralinepag, a highly selective and potent IP receptor agonist, utilizes multiple pathway effects, including vasodilatory, anti-proliferative, and anti-inflammatory. Ralinepag has exhibited 6-fold higher binding affinity than MRE-269, the active metabolite in selexipag, and has achieved sustained IP receptor occupancy similar to parental therapy. It restores prostacyclin signaling and activates IP receptors on pulmonary artery endothelial and smooth muscle cells, triggering downstream conversion of ATP to cAMP.

“PAH is a progressive, life-threatening disease that has a devastating impact on patients’ lives,” Vallerie McLaughlin, MD, Kim A. Eagle MD endowed professor of cardiovascular medicine and director of the pulmonary hypertension program at the University of Michigan and chair of the ADVANCE OUTCOMES steering committee, said in a statement. “In the ADVANCE OUTCOMES study, ralinepag delayed disease progression in patients with PAH facing significant disease burden at baseline. Ralinepag’s potency and once-daily oral dosing make these outcomes highly relevant in real-world settings.”

ADVANCE OUTCOMES was a pivotal multicenter, global, randomized, double-blind, placebo-controlled, event-driven phase 3 study evaluating the efficacy and safety of ralinepag in patients with PAH. The primary endpoint was time to first adjudicated clinical worsening event, which was defined as death, nonelective hospital admission for worsening PAH, initiation of inhaled prostacyclin pathway or parental agent for treatment of worsening PAH, disease progression, or unsatisfactory long-term clinical response.

Key secondary endpoints included changes from baseline to week 28 in NT-proBNP, 6MWD, and WHO/NYHA FC; shift and proportion of patients with improved risk status, clinical improvement, or health-related quality of life; time to first all-cause nonelective hospitalization; time to all-cause mortality; heart rate recovery after completion of 6MWT; and safety and tolerability.

Patients were eligible for enrollment if they were ≥18 years old and had a diagnosis of symptomatic PAH, as well as right heart catheterization performed at or within 3 years before screening, WHO/NYHA functional class II to IV symptoms, a 6-minute walk distance (6MWD) of ≥150 meters, or were taking PAH-specific background oral therapies, among other criteria. Patients were excluded if they presented with known HIV-associated PAH, ≥3 left ventricular dysfunction risk factors, more than mild lung disease on pulmonary function tests, or evidence of thromboembolic disease, among other criteria.

A total of 687 patients were enrolled in the study and randomly assigned in a 1:1 ratio to either ralinepag or placebo, both in addition to standard of care PAH-specific background therapy. Once-daily dosing was individualized based on tolerability and response – no dose ceiling was specified.

Ultimately, ralinepag demonstrated a 55% reduction in clinical worsening event risk (HR 0.45; 95% CI, 0.33-0.62; 

 <.0001). The drug also saw durable efficacy in delaying disease progression – 80% of patients were on dual background therapy, and 70% were considered WHO/NYHA functional class II at baseline. Ralinepag also improved 6MWD and NT-proBNP compared to placebo, with increased odds of achieving improvement by 47% from baseline to week 28.

Investigators noted that these benefits were consistent across all patient subgroups, including time since diagnosis, baseline 6MWD, use of background therapies, and disease etiology. Additionally, ralinepag was well-tolerated and exhibited a safety profile consistent with known prostacyclin-related adverse events.

“These results mark a significant advancement for PAH patients,” Derek Solum, PhD, senior director of product development at United Therapeutics and the lead for the global ADVANCE OUTCOMES program, said in a statement. “With its extended-release profile and pharmacokinetic characteristics that mimic the steady-state exposure of parental therapy, ralinepag provides disease-mitigating capabilities that target underlying PAH pathology and achieve impressive clinical benefits.”

United Therapeutics. United Therapeutics Corporation Announces Ralinepag Achieved 55% Reduction in Risk of Clinical Worsening in Pivotal Pulmonary Arterial Hypertension Study, Delivering Exceptional, Highly Statistically Significant Efficacy. 

. March 2, 2026. Accessed March 2, 2026. 

https://www.businesswire.com/news/home/20260302493703/en/United-Therapeutics-Corporation-Announces-Ralinepag-Achieved-55-Reduction-in-Risk-of-Clinical-Worsening-in-Pivotal-Pulmonary-Arterial-Hypertension-Study-Delivering-Exceptional-Highly-Statistically-Significant-Efficacy

United Therapeutics. A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients. ClinicalTrials.gov Identifier: NCT03626688. Updated February 20, 2026. Accessed March 2, 2026. 

https://clinicaltrials.gov/study/NCT03626688

United Therapeutics reported phase 3 evidence that once-daily oral ralinepag, a potent, highly selective IP receptor agonist designed to restore prostacyclin signaling, significantly delayed disease progression in pulmonary arterial hypertension. In the global, randomized, double-blind, placebo-controlled, event-driven ADVANCE OUTCOMES trial (n=687) on top of background therapy, ralinepag reduced risk of first adjudicated clinical worsening by 55% (HR 0.45; 95% CI, 0.33–0.62; P<.0001). Improvements were also observed in 6MWD and NT-proBNP, with expected prostacyclin-class tolerability.

Parent company United Therapeutics announced ralinepag’s substantial reduction in worsening clinical events, as well as improving 6MWD and NT-proBNP.

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ADVANCE OUTCOMES: Ralinepag Outperforms Placebo in Slowing Disease Progression in PAH

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

AbbVie has announced positive topline results from the phase 3, randomized, placebo-controlled, double-blind AFFIRM study evaluating the efficacy and safety of risankizumab (Skyrizi) subcutaneous (SC) induction treatment versus placebo in adult patients with moderately to severely active Crohn's disease (CD).

As described in the March 2, 2026, press release from the Company, AFFIRM study results showed significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of Crohn's Disease Activity Index (CDAI) clinical remission and endoscopic response at week 12 compared to placebo. Of note, among patients with clinical response after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.

"Crohn's disease is a complex, often debilitating condition that affects far more than a patient's digestive health, disrupting work, relationships and daily life," Millie Long, MD, MPH, chief of the division of Gastroenterology and Hepatology at University of North Carolina, Chapel Hill, and lead investigator of the AFFIRM study, said in a statement. "These high endoscopic response rates across populations, in particular among those who have not failed an advanced therapy, demonstrate the potential of subcutaneous induction risankizumab as an effective therapy for Crohn's disease."

Risankizumab is an interleukin (IL)-23 inhibitor that selectively blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases. It is approved by the US Food and Drug Administration and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis.

The efficacy and safety of risankizumab SC as an induction treatment in adult patients with moderately to severely active Crohn's disease was assessed in the global, phase 3, randomized, placebo-controlled, double-blind AFFIRM study. Co-primary endpoints were percentage of participants with CDAI Clinical Remission (CDAI < 150) and percentage of participants with endoscopic response at week 12.

A total of 289 patients were randomly assigned in a 2:1 ratio to risankizumab SC or placebo. Investigators noted key demographics and baseline characteristics were generally balanced between the risankizumab SC and placebo groups, with 65% having failed advanced therapies for the treatment of CD before. Of those patients, 50% failed ≥ 2 advanced therapies, 23% failed ustekinumab, and 12% failed a Janus kinase inhibitor.

AFFIRM consists of 3 treatment periods, including a placebo-controlled Period A (baseline to week 12) to evaluate the efficacy and safety of risankizumab SC induction treatment, an extended Period B (week 12 to 24) where patients receive blinded or open-label treatments based on their clinical response at week 12, and a 52-week open-label extension Period C where all patients receive the approved risankizumab maintenance treatment.

Results showed significantly greater proportions of patients treated with risankizumab SC induction achieved the co-primary endpoints of CDAI clinical remission (55% vs 30%; 

 <.0001) and endoscopic response (44% vs 14%; 

 <.0001) at week 12 compared to placebo. Among patients with clinical response after 12 weeks of risankizumab SC induction treatment followed by 12 weeks of maintenance, 67% achieved CDAI clinical remission at week 24 and 57% achieved endoscopic response at week 24.

During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab SC was consistent with the safety profile observed in Crohn's disease with no new safety risks observed. The most common adverse events observed among patients receiving risankizumab were upper respiratory tract infection, abdominal pain and arthralgia. Serious adverse events occurred in 0.5% of patients in the risankizumab SC group compared to 3.1% in the placebo group.

AbbVie described plans to publish full results in an upcoming medical journal and additionally share them at future medical congresses.

"This study evaluated a difficult-to-treat Crohn's disease patient population, including a majority with a prior failure to advanced therapy, and these data reinforce risankizumab as a leading, effective treatment for patients," said Kori Wallace, MD, PhD, vice president, global head of immunology clinical development at AbbVie. "The level of endoscopic response is a particularly meaningful achievement for Crohn's disease patients; and for AbbVie, these results underscore our continued innovation and research to raise the standard of care."

AbbVie. AbbVie Announces Positive Topline Results from Phase 3 AFFIRM Study Evaluating SKYRIZI® (Risankizumab) Subcutaneous Induction in Patients with Crohn's Disease. March 2, 2026. Accessed March 2, 2026. 

https://news.abbvie.com/2026-03-02-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-AFFIRM-Study-Evaluating-SKYRIZI-R-Risankizumab-Subcutaneous-Induction-in-Patients-with-Crohns-Disease

Brooks A. FDA Approves Risankizumab (Skyrizi) for Ulcerative Colitis. HCPLive. June 18, 2024. Accessed March 2, 2026. 

https://www.hcplive.com/view/fda-approves-risankizumab-skyrizi-for-ulcerative-colitis

Phase 3 AFFIRM demonstrated that subcutaneous risankizumab induction significantly improved week-12 CDAI clinical remission and endoscopic response versus placebo in moderately to severely active Crohn’s disease. In patients achieving clinical response at week 12 and continuing maintenance, remission and endoscopic response rates at week 24 were 67% and 57%, respectively. The global trial enrolled a largely treatment-refractory population, with 65% having failed prior advanced therapies. Safety was consistent with prior Crohn’s experience, without new signals and fewer serious adverse events than placebo.

Risankizumab achieved superiority for the co-primary and ranked secondary endpoints at week 12 for SC injection versus placebo.

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AFFIRM: Risankizumab (Skyrizi) Subcutaneous Induction Achieves Primary Endpoints in Crohn’s Disease

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.

Rusfertide, as a potential first-in-class therapy for 

, had its New Drug Application (NDA) accepted and Priority Review granted by the 

The results were announced by Takeda and Protagonist on March 2, 2026, based on results from the phase 3 VERIFY, phase 2 REVIEW, and long-term extension THRIVE study, with the Prescription Drug User Fee Act (PDUFA) target action date set for the third quarter of this calendar year.

PV is a rare, slow-growing blood cancer where bone marrow overproduces red blood cells, causing hyperviscosity, along with secondary white blood cell and platelet production. The myeloproliferative disorder is associated with a Janus kinase-2 (JAK2) mutation, which causes the neoplastic proliferation of the hematopoietic progenitor cells. The primary treatment goal for PV is to control hematocrit levels <45% to prevent thrombotic events and alleviate burdensome symptoms.

Previously, rusfertide, an investigational, first-in-class hepcidin mimetic peptide therapeutic for the treatment of adults with PV, already received designation for Breakthrough Therapy, Orphan Drug, and Fast Track from the Agency. By targeting the underlying mechanism of iron dysregulation in polycythemia vera, rusfertide aims to reduce excess red blood cell production and help patients achieve sustained hematocrit control.

“There is an urgent need for innovative treatment options in polycythemia vera, where patients currently face limited therapeutic choices to control their hematocrit and significant symptom burden,” said Andy Plump, MD, PhD, president of R&D at Takeda in a statement. “The FDA's acceptance of our NDA brings us closer to potentially offering a first-in-class therapy that could meaningfully improve clinical outcomes and quality of life. This milestone is a reflection of our successful partnership with Protagonist and Takeda’s unwavering commitment to advancing innovative treatments in hematologic cancers where significant unmet needs persist.”

According to the release, the NDA for rusfertide was based primarily on positive 32-week primary analysis and 52-week results from the global, randomized, phase 3 VERIFY study, as well as 4-year efficacy and safety data from phase 2 REVIEW and long-term extension THRIVE.

The primary endpoint of VERIFY was the proportion of patients who achieved a response during Weeks 20-32, defined as the absence of “phlebotomy eligibility.” To meet phlebotomy eligibility, patients in the study were required to have a confirmed hematocrit ≥45% that was ≥3% higher than their baseline hematocrit value, or a hematocrit ≥48%.

In VERIFY, rusfertide met the primary endpoint and all 4 key secondary endpoints, and compared to receiving the current standard of care alone, patients receiving rusfertide plus the current standard of care demonstrated an increased response rate. Among these results were hematocrit control, a reduction in phlebotomy requirements, and improvement in pre-specified patient-reported outcomes of fatigue and symptom burden.

Over 52 weeks of treatment, rusfertide was generally well-tolerated. The most common treatment-emergent adverse events (AEs) in rusfertide-treated patients were injection site reactions (47.4%), anemia (25.6%), and fatigue (19.6%), a majority of which were grade 1 or 2. Of rusfertide-treated patients, serious AEs occurred in 8.1% of individuals.

After completing their participation in the randomized, placebo-controlled portion of the study, all patients are now in the open-label portions of the study.

Takeda and Protagonist Announce U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Rusfertide as a Potential First-in-Class Therapy for Polycythemia Vera. BusinessWire. Published March 2, 2026. Accessed March 2, 2026. 

https://www.businesswire.com/news/home/20260301580219/en/Takeda-and-Protagonist-Announce-U.S.-Food-and-Drug-Administration-Accepts-New-Drug-Application-and-Grants-Priority-Review-for-Rusfertide-as-a-Potential-First-in-Class-Therapy-for-Polycythemia-Vera

Lu X, Chang R. Polycythemia Vera. PubMed. Published April 24, 2023. 

https://www.ncbi.nlm.nih.gov/books/NBK557660/

Takeda and Protagonist secured FDA acceptance and Priority Review for the rusfertide NDA in adults with polycythemia vera, with a PDUFA action expected in Q3. Rusfertide is a first-in-class hepcidin mimetic intended to address PV-associated iron dysregulation and reduce erythrocytosis to sustain hematocrit control below 45%. The application is supported by phase 3 VERIFY (32-week primary analysis; 52-week data) and longer-term phase 2/extension follow-up, showing improved hematocrit control, fewer phlebotomies, and better fatigue/symptom scores with manageable toxicity.

The FDA granted Priority Review and accepted a New Drug Application for rusfertide to treat adults with polycythemia vera. 


Hematology

FDA News

FDA Accepts New Drug Application for Rusfertide, Grants Priority Review In Polycythemia Vera

Frances Lee, MD, is an assistant professor of medicine in the division of liver diseases at Mount Sinai.

Future Advancements in PBC Care: Innovations on the Horizon

In the final episode, “Future Advancements in PBC Care: Innovations on the Horizon,” the panelists explore current gaps in care and new treatments that are trying to close those gaps.

Led by the moderator, the panelists examine the following critical questions:

Looking ahead towards the future of primary biliary cholangitis care, what ongoing trials or emerging treatments do you feel are promising or practice-changing?

What is one final pearl you would like to share about the management of primary biliary cholangitis and the future ahead?

Throughout the conversation, the experts provide a comprehensive reflection on the field and the factors that may shape how clinicians approach care moving forward.

Thank you for watching this Peer Exchange series on PBC. Please subscribe to our newsletter for information on upcoming video series.

Neal Bhatia, MD, speaks on new data on ixekizumab and tirzepatide for weight loss and psoriasis, as well as the implications of these data regarding GLP-1 use.

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Discussing GLP-1 or Dual Incretin Therapies in IL-17 Mediated Disease, With Neal Bhatia, MD

Medical student at John Sealy School of Medicine, University of Texas in Galveston

Nguyen discussed how her study findings can help alleviate inhaled corticosteroid hesitancy for families.

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Addressing ICS Hesitancy in Pediatric Asthma Care, With Lynchi Nguyen

Jose Clemente, PhD, associate professor of Genetics and Genomics and Immunology at the Icahn School of Medicine at Mount Sinai

Early gut microbiome changes in c-section infants linked to food sensitization at 12 months, highlighting a potential critical intervention window.

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Early Microbiome Shifts May Define a Critical Window for Allergy Risk, With Jose Clemente, PhD

Trial data show early microbiome shifts after vaginal microbial transfer in cesarean-delivered infants, with differences in food sensitization at 12 months.

Vaginal Seeding Partially Modifies Infant Microbiome in ACTIVATE, With Jose Clemente, PhD

Nguyen emphasized the safety of inhaled corticosteroids vs SABA-only therapy in pediatric asthma.

Alleviating Pediatric Fracture Risk Concerns With Asthma ICS, With Lynchi Nguyen

Matthew Krantz, MD, from Vanderbilt University Medical Center

HLA-A*32:01 carrier screening may identify patients at elevated risk for lamotrigine-induced eosinophilia and systemic symptoms, Krantz says at AAAAI 2026.

HLA-A*32:01 Carrier Screening Feasibility Before Lamotrigine, With Matthew Krantz, MD

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

A new study stratified patients by longitudinal BEC patterns to assess whether variability in eosinophil levels influences response.

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Mepolizumab Reduces Type 2 COPD Exacerbations Across Variable BEC Levels

Prospective case-control data presented at AAAI 2026 demonstrate a 12-fold increased odds of DRESS among lamotrigine-treated HLA-A*32:01 carriers.

HLA-A*32:01 Linked to Lamotrigine DRESS Risk, With Matthew Krantz, MD

Gerald Appel, MD, is a professor of clinical medicine, director of clinical nephrology, and director of the Glomerular Disease Center at Columbia University.

On Rare Disease Day 2026, clinicians share their perspective on the evolving landscape for IgAN and C3G. 

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Rare Disease Day 2026: Kidney Diseases Enter Optimistic Therapeutic Era

Retrospective analysis presented at AAAAI 2026 found 12%–15% risk reductions in asthma exacerbations over 3 years among patients without diabetes with overweight and obesity.

Latest News

5 Cardiology Headlines You Missed in February 2026

ADVANCE OUTCOMES: Ralinepag Outperforms Placebo in Slowing Disease Progression in PAH

AFFIRM: Risankizumab (Skyrizi) Subcutaneous Induction Achieves Primary Endpoints in Crohn’s Disease

FDA Accepts New Drug Application for Rusfertide, Grants Priority Review In Polycythemia Vera

Future Advancements in PBC Care: Innovations on the Horizon