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.

American Thoracic Society (ATS) 2026 International Conference 

in May and capped by expert coverage from the 

Association of Pulmonary Advanced Practice Providers (APAPP) National Conference

 in June. The quarter's defining readout came from the phase 3 TETON-1 trial, in which nebulized treprostinil demonstrated unprecedented efficacy across multiple endpoints in IPF — including the first statistically significant DLCO improvement in any phase 3 IPF trial and a regulatory submission planned for summer 2026. Across obstructive and vascular pulmonary disease, ralinepag's 55% PAH worsening reduction in ADVANCE OUTCOMES, tozorakimab's third consecutive positive phase 3 COPD exacerbation readout in MIRANDA, and the BGF triple inhaler's long-awaited approval for patients aged 12 and older rounded out a quarter defined by late-stage clinical momentum.

Conference coverage also yielded new real-world PASSAGE data on tezepelumab across underrepresented asthma populations, an ATS-presented cohort linking long-term insulin resistance to CT-quantified ILD, and a timely APAPP session on the unified airway as a framework for reducing asthma hospitalization risk. 

Here's a concise overview of the key pulmonology stories from Q2 2026.

Tozorakimab Meets Primary Endpoint in Phase 3 MIRANDA COPD Trial

AstraZeneca announced in April that tozorakimab met its primary endpoint in the phase 3 MIRANDA trial, reducing annualized moderate-to-severe COPD exacerbation rates versus placebo in former smokers and in the overall population — including current smokers across all eosinophil levels and lung function severity stages — when added to inhaled standard of care. The result marks the third consecutive positive phase 3 readout in the LUNA program, following OBERON and TITANIA, and extends the exacerbation reduction signal to a more frequent subcutaneous dosing regimen. The consolidating evidence base positions tozorakimab for anticipated regulatory submissions in COPD.

Reducing COPD Exacerbations With Tozorakimab, With Frank Sciurba, MD

FDA Approves BGF Triple Inhaler for Patients Aged 12 and Older

The FDA approved budesonide/glycopyrrolate/formoterol fumarate (BREZTRI Aerosphere; AstraZeneca) as the first single-inhaler ICS/LABA/LAMA triple combination for patients aged 12 and older, extending a treatment paradigm previously limited to adults into adolescent patients with asthma or COPD. The approval was grounded in phase 3 KALOS and LOGOS data, published in The Lancet Respiratory Medicine, which showed a pooled 76 mL improvement in trough FEV₁ and a reduction in severe exacerbations over dual therapy. The pediatric and adolescent label expansion addresses a population that had previously been managed with separate controller agents.

BGF Triple Therapy FDA Approval Expands Asthma Options for Underserved Patients, With Juanita Mora, MD

Inhaled Treprostinil Improves IPF Outcomes in Phase 3 TETON-1 Trial

Nebulized treprostinil (Tyvaso; United Therapeutics) reduced FVC decline by 130.1 mL vs placebo (95% CI, 82.2 to 178.1; 

 <.001) and cut the risk of a composite clinical worsening endpoint — encompassing ≥10% relative FVC decline, respiratory hospitalization, and all-cause mortality — by 33% (HR, 0.67; 

 =.003) over 52 weeks in the phase 3 TETON-1 trial, presented at ATS 2026. In a combined analysis with TETON-2, the program met 5 of 6 secondary endpoints, including a 48% reduction in acute exacerbations (

 =.0223) and the first significant DLCO improvement demonstrated by any IPF therapy in a phase 3 trial. United Therapeutics plans to submit a supplemental NDA by summer 2026 seeking priority review for the IPF indication, which would make nebulized treprostinil the first inhaled therapy approved for the condition.

Ralinepag Achieves 55% Risk Reduction in PAH in Phase 3 ADVANCE OUTCOMES

Ralinepag, an investigational once-daily oral prostacyclin receptor agonist with higher potency than existing agents in this class, reduced the risk of clinical worsening in pulmonary arterial hypertension by 55% vs placebo (HR, 0.45; 

 <.0001) in the phase 3 ADVANCE OUTCOMES trial, presented at ATS 2026 by Vallerie McLaughlin, MD. Secondary endpoints showed significant NT-proBNP reductions, improved 6-minute walk distance, and 47% greater odds of clinical improvement. United Therapeutics has announced plans for an FDA new drug application submission in the second half of 2026.

Tezepelumab Reduces Severe Asthma Across Phenotypes in Phase 4 PASSAGE

Phase 4 PASSAGE data presented at ATS 2026 showed tezepelumab, an anti-TSLP monoclonal antibody, reduced annualized asthma exacerbation rates by 70% (95% CI, 63 to 75) in a 286-patient real-world cohort intentionally enriched for populations excluded from pivotal trials — including active smokers with ≥10 pack-years, patients with mild-to-moderate comorbid COPD, and Black or African American patients. Exacerbation reductions ranged from 54% to 77% across subgroups regardless of eosinophil count or allergic status, and clinically meaningful improvements were observed across validated asthma control and quality-of-life measures. The findings support biologic use in patients previously considered poor candidates due to smoking history or airflow obstruction.

Insulin Resistance Linked to CT-Quantified Interstitial Lung Disease

A Multicenter AIDS Cohort Study analysis presented at ATS 2026 found that each doubling in long-term, time-weighted insulin resistance was associated with a 1.58% greater percentage of lungs with ILD features on cardiac CT (95% CI, 0.38 to 2.78), an effect driven primarily by ground glass opacity rather than established fibrosis and independent of HIV or diabetes status. Investigator Sarath Raju, MD, of Johns Hopkins University, said the predominance of ground glass over scarring may point to metabolic inflammation as an early, potentially modifiable precursor to fibrotic lung disease, with plans to validate the findings in larger population-based cohorts. The analysis raises the question of whether targeting insulin resistance before overt diabetes could have a role in lung disease prevention.

Unified Airway Disease: Rhinitis, Nasal Polyps, and NERD as Drivers of Asthma Burden

At the APAPP National Conference, Heather O'Connell, PA-C, MS, presented the unified airway concept — the principle that the nose, sinuses, and lungs function as a single inflammatory unit — and outlined how allergic rhinitis, chronic sinusitis with and without nasal polyps, and NSAID-exacerbated respiratory disease (NERD) are systematically underrecognized contributors to asthma severity and hospitalization risk. She cited data identifying rhinitis as the most prevalent risk factor for 30-day asthma readmission and noted that allergy immunotherapy has demonstrated up to 75% exacerbation reduction in seasonal allergic rhinitis, approaching biologic-level efficacy. O'Connell also recommended that clinicians proactively screen patients with severe asthma and nasal polyps for NERD, noting that reduced NSAID use means the classic aspirin-triggered reaction may never have occurred at presentation.

ALA State of the Air 2026: Clinician Action

The American Lung Association's 27th annual State of the Air report found that 44% of Americans — approximately 152.3 million people — live in counties receiving failing grades for ozone or fine particulate matter levels, with failing ozone grades now spanning 219 counties across 36 states, the broadest distribution since 2016. The report attributed the trend in part to climate change-driven ozone formation and expanding wildfire smoke events, and identified children — particularly Hispanic and Latino children, who are approximately 3 times more likely than white children to live in a community failing all 3 pollutant grades — as the population bearing the greatest physiological burden. Pulmonologists Juanita Mora, MD, and Vin Gupta, MD, MPA, discussed clinical and advocacy implications, with Mora calling on clinicians to engage legislators on EPA funding and clean air protections.

Articles

Q2 2026 featured late-stage clinical momentum across fibrotic, obstructive, and vascular pulmonary disease, highlighted by major ATS 2026 readouts and APAPP practice-focused sessions. Nebulized treprostinil in IPF delivered a phase 3 signal spanning FVC, clinical worsening, acute exacerbations, and the first statistically significant DLCO improvement in a phase 3 IPF program, with a summer 2026 sNDA planned. Additional catalysts included tozorakimab’s third positive phase 3 COPD exacerbation outcome, ralinepag’s robust PAH worsening reduction, and BGF triple-therapy label expansion to adolescents.

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 3 months.

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8 Pulmonology Headlines you Missed in Q2 2026

Welcome back to our recap of news and updates from the 

Q2 2026 delivered one of the most active regulatory quarters in recent memory, spanning novel first-in-class approvals, landmark pediatric expansions, and several long-anticipated decisions across endocrinology, nephrology, dermatology, ophthalmology, and rheumatology. The quarter's standout approval came on April 1, when orforglipron became the first once-daily oral small-molecule GLP-1 receptor agonist approved for adults with obesity or overweight — a class-first that requires no food or water restrictions. In nephrology, sparsentan received the first-ever FDA approval for focal segmental glomerulosclerosis in April, offering the only non-immunosuppressive oral option for a disease with no previously approved therapy. 

June rounded out the quarter with the accelerated approval of teplizumab as the first disease-modifying therapy for children aged 8 to 17 recently diagnosed with stage 3 type 1 diabetes, the approval of olezarsen as the first agent specifically indicated to reduce acute pancreatitis risk in severe hypertriglyceridemia, and veligrotug-vvze as the first thyroid eye disease therapy approved with labeling covering both active and chronic disease. Additional highlights include dupilumab's expansion to children aged 2 to 11 with chronic spontaneous urticaria, risankizumab's first-ever pediatric approval for plaque psoriasis and psoriatic arthritis, the subcutaneous anifrolumab autoinjector for systemic lupus erythematosus, and bemotrizinol's addition to the OTC sunscreen monograph as the first new active ingredient in more than 25 years. 

Here's a concise overview of the key FDA decisions and updates from Q2 2026:

 Adults with obesity, or adults with overweight who also have at least 1 weight-related medical problem, as an adjunct to reduced-calorie diet and increased physical activity

 Orforglipron (Foundayo; Eli Lilly) is a once-daily small-molecule non-peptide oral GLP-1 receptor agonist — the first in the GLP-1 class that can be taken at any time without food or water restrictions. In the phase 3 ATTAIN-1 trial (

 = 3127 adults without diabetes), participants on the highest dose lost an average of 27.3 pounds (12.4%) at 72 weeks vs 2.2 pounds (0.9%) with placebo, with improvements across cardiometabolic risk markers including waist circumference, non-HDL cholesterol, and systolic blood pressure. The small-molecule formulation bypasses the timing constraints associated with existing oral peptide-based GLP-1 therapies, a distinction with potential implications for adherence. A regulatory submission for a type 2 diabetes indication is anticipated later in 2026.

Diabetes Dialogue: Orforglipron Receives FDA Approval for Chronic Weight Management

 Focal segmental glomerulosclerosis (FSGS) in adults and children aged 8 years and older

 Sparsentan (Filspari; Travere Therapeutics) is the first-ever FDA-approved therapy for FSGS, a leading cause of nephrotic syndrome and primary FSGS-related kidney failure that had no approved pharmacotherapy prior to this action. The drug is the only non-immunosuppressive oral agent indicated for the condition; it directly targets podocyte injury by blocking both endothelin A receptors and angiotensin II subtype 1 receptors, reducing proteinuria beyond what is achievable with maximal renin-angiotensin system blockade alone. The approval was supported by the phase 3 DUPLEX trial and phase 2 DUET study. The PDUFA date had been extended from January 13 to April 13, 2026, following an FDA request for further characterization of clinical benefit. Sparsentan had previously received full FDA approval for IgA nephropathy.

Why Sparsentan's FDA Approval Marks a Turning Point in FSGS, With Howard Trachtman, MD

 Chronic spontaneous urticaria (CSU) in children aged 2 to 11 years that remains symptomatic despite H1 antihistamine treatment

 The FDA's approval of dupilumab (Dupixent; Regeneron/Sanofi) for CSU in children aged 2 to 11 extends the prior indication in adults and adolescents aged 12 and older, making it the first biologic approved for CSU in this younger age group. Dupilumab is an IL-4Rα inhibitor that blocks both IL-4 and IL-13 signaling; its upstream mechanism of action may address the type 2 inflammatory drivers that contribute to mast cell activation in antihistamine-refractory CSU. The expansion addresses a population in whom antihistamine failure leaves limited therapeutic options and disease burden can substantially affect quality of life and development.

 Subcutaneous self-administration in adults with moderate to severe systemic lupus erythematosus (SLE) receiving standard therapy

 The FDA approved a subcutaneous once-weekly 120 mg autoinjector formulation of anifrolumab-fnia (Saphnelo Pen; AstraZeneca), a type I interferon receptor antagonist, expanding on the existing intravenous infusion route and enabling patient self-administration outside the clinical infusion setting. Approval was based on the phase 3 TULIP-SC trial, in which 29% of patients achieved DORIS remission and 40.1% attained low-level disease activity. The subcutaneous formulation may improve long-term convenience and adherence in a chronic disease requiring sustained biologic management, and avoids the scheduling burden associated with regular infusion visits.

 Addition to the OTC sunscreen monograph as an active sunscreen ingredient at concentrations up to 6%, for adults and children aged 6 months and older

 Bemotrizinol (PARSOL Shield; DSM-Firmenich) became the first new active sunscreen ingredient permitted in the US since the late 1990s, closing a more than 25-year gap during which available UV filters in American sunscreens lagged behind those available in Europe and Asia. The action was finalized in approximately 7 months under the CARES Act administrative order pathway, the first ingredient to clear this streamlined process. Bemotrizinol provides broad-spectrum UVA and UVB coverage with high photostability, low percutaneous absorption, and no white cast — addressing both efficacy and cosmetic tolerability limitations associated with some older organic filters. Manufacturers may begin incorporating it into OTC products beginning August 9, 2026, with DSM-Firmenich holding exclusive marketing rights for the first 18 months.

 To delay the decline of endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with stage 3 type 1 diabetes (T1D)

 Teplizumab-mzwv (Tzield; Sanofi) received accelerated approval for this new indication, making it the first FDA-approved disease-modifying therapy for patients recently diagnosed with stage 3 T1D. The anti-CD3 monoclonal antibody partially exhausts the autoreactive T cells driving pancreatic beta-cell destruction; approval relies on C-peptide preservation as a surrogate endpoint from the phase 3 PROTECT trial, with continued authorization contingent on confirmatory data from the ongoing BETA-PRESERVE trial. Tzield had previously been approved to delay progression from stage 2 to stage 3 T1D; this action extends its disease-modifying role into the newly diagnosed clinical disease setting. The drug carries a boxed warning for serious viral reactivation, including Epstein-Barr virus and cytomegalovirus.

 Adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia (triglycerides ≥500 mg/dL)

 Olezarsen (Tryngolza; Ionis Pharmaceuticals) became the first therapy approved specifically to reduce acute pancreatitis risk in severe hypertriglyceridemia, addressing a gap that persisted despite decades of available triglyceride-lowering agents — none of which had generated sufficient pancreatitis event data in controlled trials to establish a risk reduction claim. The antisense oligonucleotide inhibits hepatic APOC3 production to enhance triglyceride clearance; phase 3 CORE and CORE2 data showed placebo-adjusted fasting triglyceride reductions of approximately 49% to 72% at 6 months and an 85% reduction in acute pancreatitis events. Approval arrived ahead of the June 30 PDUFA date and extends olezarsen's existing US label for familial chylomicronemia syndrome to the broader severe hypertriglyceridemia population, estimated at more than 3 million US adults.

 Thyroid eye disease (TED), regardless of disease activity or duration

 Veligrotug-vvze (Lumvoa; Viridian Therapeutics), a monoclonal antibody that fully antagonizes the insulin-like growth factor-1 receptor (IGF-1R) to disrupt the IGF-1R/TSHR cross-talk driving orbital inflammation, became the first TED therapy approved with labeling covering both active and chronic disease and the first in this class to demonstrate a statistically significant effect on both diplopia response rate and complete resolution of diplopia across the full disease spectrum. Approval was granted with Priority Review and Breakthrough Therapy designation, based on the phase 3 THRIVE and THRIVE-2 trials evaluating a 12-week IV regimen administered as 5 infusions every 3 weeks. Safety monitoring is warranted for hearing impairment (potentially permanent), hyperglycemia (~12%), and infusion reactions (~9%).

 Moderate-to-severe plaque psoriasis in children aged 6 years and older who are candidates for systemic therapy or phototherapy; active psoriatic arthritis in children aged 6 years and older

 Risankizumab-rzaa (Skyrizi; AbbVie), an IL-23 inhibitor that selectively binds the p19 subunit to suppress the inflammatory cascade driving psoriatic disease, became the first IL-23 inhibitor approved in the US for pediatric patients weighing less than 40 kg with either condition. A new 55-mg prefilled syringe supports weight-based dosing for children under 40 kg, complementing the existing 150-mg formulation for those at or above that threshold. The pediatric plaque psoriasis approval is supported by the phase 3 OptIMMize program, which showed clinically meaningful sPGA and PASI improvements at week 16 sustained through week 52 in children aged 6 to 11; the psoriatic arthritis indication is supported by the OptIMMize psoriasis data plus population pharmacokinetic modeling from adult PsA trials. Risankizumab already holds adult approvals for plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

A review of 9 novel drugs approved by the US Food and Drug Administration during the second quarter of 2026.

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FDA News Recap: Novel Drug Approvals in Q2 2026

The US Food and Drug Administration (FDA) on July 1, 2026, granted supplemental approval to exagamglogene autotemcel (Casgevy; Vertex Pharmaceuticals) for patients aged 2 years and older with 

(SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β-thalassemia (TDT), extending an indication previously limited to patients aged 12 and older.¹ The action makes exa-cel the first gene therapy approved for young children with SCD and the first CRISPR-based gene-editing therapy to reach this age group in either condition.

The supplemental approval was reviewed in 53 days following filing as the eighth therapy selected under the FDA Commissioner's National Priority Voucher pilot program, which is designed to accelerate review of treatments for diseases with significant unmet medical need.¹ Exa-cel previously received Orphan Drug, Regenerative Medicine Advanced Therapy (RMAT), and Fast Track designations.

Exa-cel is an autologous cell therapy manufactured from a patient's own hematopoietic stem and progenitor cells, which are edited ex vivo using CRISPR/Cas9 technology to reactivate fetal hemoglobin (HbF) production by targeting the erythroid enhancer region of BCL11A. In SCD, increased HbF inhibits red blood cell sickling, reducing or eliminating VOCs. In TDT, elevated HbF and total hemoglobin levels eliminate dependence on regular red blood cell transfusions. Exa-cel is administered as a 1-time intravenous infusion; full myeloablative conditioning with busulfan is required prior to infusion and engraftment in bone marrow.¹

Efficacy and safety in children aged 5 to less than 12 years with SCD were evaluated in a clinical trial enrolling 11 patients. All 8 efficacy-evaluable patients achieved the primary endpoint of VF12 — defined as freedom from protocol-defined severe VOCs for at least 12 consecutive months within the first 24 months post-infusion.¹ In the corresponding TDT trial in the same age group (

 = 15), 8 of 9 efficacy-evaluable patients achieved transfusion independence for at least 12 consecutive months, with a median duration of transfusion independence of 20.1 months.¹

Clinicians should note that both pediatric cohorts were small, and the FDA's decision to extend the indication to patients as young as 2 years was granted by extrapolation based on product characteristics and clinical study data from the 5–<12 age group, not from direct trial evidence in children aged 2–4.¹ These data build on the earlier CLIMB SCD-121 pivotal trial in patients aged 12–35, in which 96.7% of efficacy-evaluable participants remained free of VOCs for at least 12 consecutive months following treatment, as reported in the 

The most common adverse events in both indications were mucositis and febrile neutropenia. Decreased appetite was additionally reported in patients with SCD. The exa-cel prescribing information carries warnings for neutrophil engraftment failure, delayed platelet engraftment, and hypersensitivity reactions. Of particular clinical significance is a warning for off-target genome editing risk — the possibility that CRISPR/Cas9 may introduce unintended edits to parts of the genome outside the intended target site; the long-term clinical consequences of such edits are not yet fully characterized.¹ Patients are planned to be followed for up to 15 years post-infusion in long-term safety studies.

"These disorders carry a heavy burden for children and their families, affecting growth, development, and long-term health in profound ways," said Megha Kaushal, MD, MSc, acting deputy director of the Office of Therapeutic Products in the FDA's Center for Biologics Evaluation and Research and a pediatric hematologist. "Grounded in the scientific evidence that earlier treatment reduces the risk of lasting end-organ damage, making this therapy available to younger patients opens a critical window for intervention."¹

US Food and Drug Administration. FDA approves first gene therapy for young children with sickle cell disease. Press release. July 1, 2026. https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-young-children-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

The FDA expanded the indication for exagamglogene autotemcel to patients aged ≥2 years with SCD and recurrent VOCs or TDT, making it the first CRISPR-based gene-editing therapy available to this pediatric age range. Review was accelerated via the National Priority Voucher program. Ex vivo CRISPR/Cas9 editing of autologous HSPCs targets the BCL11A erythroid enhancer to upregulate HbF, followed by busulfan myeloablation and one-time infusion. Pediatric data showed high VF12 and transfusion-independence rates, though evidence in ages 2–4 is extrapolated.

Exagamglogene autotemcel (Casgevy) is now the first CRISPR-based gene-editing therapy to reach this age group in either condition.

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FDA Expands Exa-Cel Gene Therapy Approval to Children 2 Years and Up With SCD or β-Thalassemia

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 second quarter of 2026 saw an influx of critical approvals from the 

 and a slew of major conferences including the American Diabetes Association (ADA) Scientific Sessions and the Endocrine Society (ENDO) Annual Meeting. Between inhaled insulin’s approval in pediatric patients and the topline efficacy of crinecerfont and retatrutide, all manner of drugs for 

With so much data coming out of this Q2, the editorial team at 

 has collected 9 of the most impactful headlines below. Catch up with any news you may have missed since April:


FDA Expands Teplizumab Approval to Children 1 Year & Older to Delay Type 1 Diabetes Onset


On April 22, 2026, parent company Sanofi announced the FDA’s extension of prior approval of teplizumab-mzwv (Tzield) to include children ≥1 year of age with stage 2 type 1 diabetes (T1D) to prevent or delay progression into stage 3 disease. The initial approval was limited to patients ≥8 years; this decision has established teplizumab as the first disease-modifying therapy available for extremely young patients at high risk of developing symptomatic T1D.


FDA Approves Inhaled Insulin Afrezza for Pediatric Patients With Diabetes


On May 29, 2026, parent company MannKind Therapeutics announced the FDA’s approval of inhaled insulin Afrezza for pediatric patients with either T1D or T2D. Afrezza, the first and only ultra-rapid-acting inhaled insulin with FDA approval for glycemic control in adults with diabetes mellitus, is administered at the start of every meal with a portable inhaler. The drug was first approved in 2014 – in January 2026, the FDA approved an updated label providing clinicians with starting dose guidance when switching from an insulin pump or daily injections.


FDA Proposes Exclusion of Multiple GLP-1 RAs from Bulks List, With Rachael Sood, NP


On April 30, 2026, the FDA announced preliminary plans to remove GLP-1 receptor agonists semaglutide, tirzepatide, and liraglutide from the 503B bulks list. This decision would mark the end of the GLP-1 shortage, as their removal from the list would prevent outsourcing facilities from compounding these drugs. In an interview with 

, Rachael Sood, NP, founder and chief executive officer of the Diabetes Collective and a speaker and clinical expert for Sanofi, Eli Lilly, Dexcom, and others, discussed the broader implications for other GLP-1 medications and other compounded medications at large.


INHALE-1: Afrezza Safe but Misses HbA1c Endpoint in Children With T1D or T2D, With Roy Beck, MD, PhD


Presented at the International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) by Roy Beck, MD, PhD, the data from this trial provided the backbone for Afrezza’s updated FDA approval for pediatric patients with diabetes. Although inhaled insulin failed to achieve its primary endpoint of HbA1c noninferiority compared to rapid-acting analogue insulin, the combination of positive safety and tolerability data and significantly greater treatment satisfaction established the trial results as positive.


Crinecerfont Reduces Glucocorticoid Doses in CAH, With Richard Auchus, MD, PhD


New data from the CAHtalyst Adult study have reflected that crinecerfont substantially reduces glucocorticoid doses among patients with classic congenital adrenal hyperplasia (CAH), sustaining these reductions over 2 years. The selective oral corticotropin-releasing factor type 1 receptor antagonist was first approved by the FDA in December 2024 to treat CAH in conjunction with glucocorticoids in adults and children ≥4 years.


TRIUMPH-1: Retatrutide Substantially Lowers Weight, BMI in Patients With Obesity or Overweight


Retatrutide, the first triple GIP/GLP-1/glucagon agonist to reach phase 3 clinical trials, has demonstrated significant weight loss in patients with obesity or overweight, according to the TRIUMPH-1 trial. Presented alongside positive data from TRANSCEND-T2D-1 at ADA 2026, this study saw an average weight loss of 64.4 lbs with retatrutide 9 mg and 70.3 lbs with retatrutide 12 mg by week 80. Additionally, 65.3% of patients on retatrutide 12 mg achieved a body mass index <30, the minimum threshold for clinical obesity.


Implementing Automated Insulin Delivery in Type 2 Diabetes, With Diana Isaacs, PharmD


At the Association of Clinical Endocrinology (AACE) Annual Meeting 2026 in April, 

 spoke with Diana Isaacs, PharmD, director of education and training in diabetes technology at Cleveland Clinic, to discuss the benefits of implementing automated insulin delivery (AID) devices into T2D care. Clinical guidelines have recently shifted to include these devices among treatment recommendations, and recent trials have indicated their efficacy in reducing glycated hemoglobin while increasing time in range.


Ketone Monitoring in Diabetes: Making The Case For When and How to Test

 spoke with Viral Shah, MD, of Indiana University, regarding the importance of – and the shifting attention towards – continuous ketone monitoring. An ADA consensus published prior to the conference established universal diabetes education on ketones as a minimum standard – Shah framed prevention of diabetic ketoacidosis as the central priority of the field, highlighting the critical need to identify elevated ketones early on to intervene.


Berobenatide Monthly Dosing Shows Weight Loss Efficacy in VESPER Trials, With John Buse, MD, PhD


Findings from the VESPER-1 and VESPER-3 trials reflected berobenatide’s efficacy in reducing overweight or obesity in patients with or without T2D. Berobenatide is an investigational ultra-long-acting GLP-1 RA, administered monthly – this substantially reduced dosing frequency, as the trials indicated, can significantly reduce treatment burden and improve treatment adherence and cost.

Q2 2026 featured consequential FDA actions and late-breaking endocrine data spanning T1D prevention, insulin delivery, obesity pharmacotherapy, and CAH management. Teplizumab gained an expanded label down to age 1 for stage 2 T1D, while inhaled insulin Afrezza was approved for pediatric T1D/T2D despite mixed glycemic efficacy, supported by safety and satisfaction outcomes. Regulators also moved toward ending GLP-1 RA compounding by revising the 503B bulks list. Trials highlighted durable glucocorticoid-sparing with crinecerfont and substantial phase 3 weight loss with retatrutide; clinicians emphasized AID in T2D and ketone monitoring.

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9 Endocrinology Headlines You Missed in Q2 2026

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.

and immunology saw significant regulatory momentum in the first half of 2026, headlined by new approvals in allergic fungal rhinosinusitis (AFRS), pediatric hereditary angioedema (HAE), and epinephrine access, alongside pipeline advances in systemic mastocytosis and HAE. Updated international guidelines further refined first-line treatment strategies for pediatric HAE and epinephrine use in anaphylaxis.

HCPLive rounds up the key FDA decisions, trial data, and guideline updates clinicians need to know from the year so far.

 (Dupixent): First therapy approved for allergic fungal rhinosinusitis (AFRS)

 (Orladeyo): First once-daily oral HAE prophylaxis for ages 2-11

: Age restriction removed; now weight-based (≥33 lbs)

: NDA accepted for non-advanced systemic mastocytosis; PDUFA date: December 30, 2026

 Fast Track designation granted for HAE (siRNA, targets prekallikrein)

Sebetralstat (Ekterly): named first-line on-demand therapy for pediatric HAE (ages ≥12)

New international consensus clarifies when to administer epinephrine for anaphylaxis

FDA Approves Dupilumab (Dupixent) for Allergic Fungal Rhinosinusitis

The FDA approved dupilumab (Dupixent) for AFRS in patients aged ≥ 6 years with a history of sinonasal surgery, marking the first therapy specifically indicated for this type 2 inflammatory CRS subtype. Approval was based on the phase 3 LIBERTY-AFRS-AIMS trial (n = 62).

At week 52, dupilumab produced a 50% improvement in Lund-Mackay CT opacification scores versus 10% with placebo. Systemic corticosteroid use and surgery risk dropped 92% relative to placebo, with nasal congestion, polyp scores, and anosmia also improving significantly.

FDA Approves Oral Berotralstat (Orladeyo) for Pediatric HAE

The FDA approved berotralstat (Orladeyo) oral pellets for long-term prophylaxis of HAE in children aged 2 to 11 years, making it the first once-daily oral option for this age group. The pellets can be sprinkled onto non-acidic food, offering an alternative to injectable therapies like lanadelumab.

Approval was based on the APeX-P trial, which showed sustained reductions in HAE attack rates, with mean monthly attacks reduced to 0. More than half of patients remained attack-free for up to 1 year. No cardiovascular safety signals were observed across age, sex, or severity subgroups.

Other FDA updates: Neffy Label Update, NDA Accepted, & More

FDA Removes Age Restriction for Epinephrine Nasal Spray (Neffy)

The FDA eliminated the minimum age requirement for 1 mg epinephrine nasal spray (neffy), shifting eligibility to weight-based criteria for patients ≥ 33 lbs, regardless of age. ARS Pharmaceuticals announced the labeling update on March 27, 2026, aligning nasal spray dosing with existing epinephrine auto-injector weight thresholds.

Nicole Chase, MD, noted the update reflects longstanding clinical practice of giving epinephrine to lower-weight children. The label also addresses storage flexibility, tolerating brief temperature extremes, and clarifies dosing technique to avoid inadvertent sniffing during administration, which has been linked to most reported adverse effects.

Weight-Based Dosing Informs Age Removal for Epinephrine Nasal Spray, With Nicole Chase, MD

FDA Removes Age Requirement for Epinephrine Nasal Spray, Now Based on Weight Alone

FDA Accepts NDA for Bezuclastinib in Non-Advanced Systemic Mastocytosis

The FDA accepted Cogent Biosciences' NDA for bezuclastinib in non-advanced systemic mastocytosis, setting a PDUFA date of December 30, 2026. The oral KIT D816V inhibitor would be the first targeted therapy for this population if approved, distinct from avapritinib, which covers advanced systemic mastocytosis only.

The phase 2 SUMMIT trial met its 24-week primary endpoint (MS2D2 total symptom score) and all key secondary endpoints, including significant reductions in tryptase, KIT D816V variant allele frequency, and marrow mast cell burden. Benefits deepened through 48 weeks, with a safety profile consistent with KIT inhibitor class effects.

FDA Grants Fast Track Designation to BW-20805 siRNA Therapy for HAE

The FDA granted Fast Track designation to BW-20805, an investigational siRNA therapy targeting hepatic prekallikrein, for HAE. Argo Biopharma announced the designation on March 16, 2026, as the therapy continues evaluation in an ongoing phase 2 trial across 3 dosing regimens in adults with HAE type 1 or 2.

As of February 2026, 80% of participants remained attack-free, with time-normalized HAE attack rate reductions ranging from 89% to 100% depending on dosing regimen. Prekallikrein levels declined 90% to 97% within the first month. A phase 3 trial is planned following primary completion later in 2026.

Updated Guidelines in HAE & Epinephrine Use

Pediatric HAE Guideline Recommends Sebetralstat as First-Line Therapy

New international pediatric HAE guidance recommends oral sebetralstat (Ekterly) as first-line on-demand therapy for acute attacks in adolescents aged ≥ 12 years. The recommendation is supported by phase 3 KONFIDENT trial data showing a mean time to symptom relief of 1.79 hours.

The guideline emphasizes early treatment at symptom onset, universal on-demand therapy access regardless of attack severity or location, and maintaining supply for ≥ 2 attacks even during prophylaxis. Sebetralstat remains unapproved for children under 12 years; the ongoing KONFIDENT-KID trial is evaluating its use in ages 2 to 11.

Updated Anaphylaxis Guidelines, Early Management Priorities

International Consensus on Epinephrine Use, With Timothy E. Dribin, MD

A 34-member international panel developed Delphi-based consensus recommendations addressing when patients should administer epinephrine for acute allergic reactions, aiming to reduce variation across existing anaphylaxis action plans. Of 24 clinical scenarios spanning cutaneous, respiratory, cardiovascular, and gastrointestinal involvement, 21 reached consensus favoring epinephrine administration.

Agreement was strongest for reactions involving multiple organ systems or isolated severe respiratory or cardiovascular symptoms. Isolated mild cutaneous or gastrointestinal symptoms did not reach consensus for epinephrine use. Real-world data cited show only 21% of children and 7% of adults receive epinephrine before emergency department arrival, underscoring persistent underuse.

Regulatory activity in allergy/immunology accelerated in early 2026, with new indications and label changes expanding options across AFRS, pediatric HAE, and anaphylaxis preparedness. Dupilumab became the first specifically indicated therapy for AFRS, demonstrating durable radiographic and clinical improvements and sharply reducing steroid use and surgery risk. Pediatric HAE prophylaxis gained a once-daily oral berotralstat formulation, while epinephrine nasal spray eligibility shifted to weight-based use without age limits. Pipeline progress included bezuclastinib’s NDA in non-advanced systemic mastocytosis and Fast Track for siRNA prekallikrein inhibition in HAE, alongside updated international guidance on sebetralstat and epinephrine administration.

A roundup of key FDA approvals, pipeline advances, and updated guidelines shaping allergy and HAE care in the first half of 2026.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Anaphylaxis

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

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Shannon C. Trotter, DO, is a dermatologist and podcast host from Springfield, Ohio.

This interview at the SDPA Summer Conference highlights key myths and how to address them as a clinician in dermatology.

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Validate families, reset expectations, and use shared decisions to manage pediatric constipation and IBS with personalized, functional goals.

Video Series

Heterogeneity, Refractory Symptoms, and Multidimensional Care in Pediatric Functional Constipation and IBS-C

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.

Catch up on the nephrology headlines you missed in June 2026. 

4 Nephrology Headlines You Missed in June 2026

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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.

A review of 22 novel drugs approved by the US Food and Drug Administration during the first half of 2026, with links to coverage from MJH Life Sciences publications.

Hepatology

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

FDA News Recap: Novel Drug Approvals in First Half of 2026

Catch up on FDA approvals, trial readouts, and key clinician insights across the cardiology specialty.

Dyslipidemia

Cardiomyopathy

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