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.

Endocrinology saw significant advancements throughout the first 6 months of 2026, between major approvals from the US Food and Drug Administration (FDA) and key trial readouts regarding everything from obesity to type 1 (T1D) and type 2 diabetes (T2D).

The FDA’s approval of inhaled insulin Afrezza for pediatric patients opened and entirely new treatment pathway for a group disproportionately affected by injection burden, while the expansion of teplizumab’s approval presents a wider safety net for pediatric patients at risk of T1D progression. Meanwhile, retatrutide made leaps and bounds in both T2D and obesity – the triple agonist brought about staggering weight loss results in phase 3 trials in May.

With all of the data presented over the last 6 months, the editorial team at 

 has taken 9 of the most impactful headlines from the first half of 2026. Catch up on any major news you may have missed:


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 Clears MiniMed Flex, A Smaller and Smartphone-Controlled Insulin Pump


On March 18, the FDA cleared MiniMed’s MiniMed Flex, a next-generation, smartphone-controlled insulin pump, for patients ≥7 years old with T1D and individuals ≥18 years old with insulin-requiring T2D. The new device is roughly half the size of the 780G pump and is MiniMed’s first screenless design, created in partnership with patients with diabetes to optimize ease of use and convenience.


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.


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.


Genentech Reports Positive Results from Phase 2 Trial of CT-388 in Obesity


On January 27, Genentech announced positive topline results from their study of CT-388, an investigational dual GLP-1/GIP receptor agonist designed for once-weekly subcutaneous administration in patients with T2D and obesity. At week 48 of the trial, 95.7% of participants receiving CT-388 saw weight loss ≥5%, and 87% lost ≥10%.


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.


GLP-1 Discontinuation Results in Significant Weight Regain, With Michael Weintraub, MD


According to a January 2026 study, ≥50% of patients with obesity or T2D regained weight within a year of discontinuing GLP-1 RA therapy, with those who lost the most weight regaining the most. This is particularly relevant with increasing reports of challenges in GLP-1 RA adherence, especially due to injection burden.


Tegoprubart Improves Glycemic Control Following Islet Transplantation for T1D, With Piotr Witkowski, MD, PhD


Eledon Pharmaceuticals announced updated results from their trial of the investigative anti-CD40L monoclonal antibody tegoprubart in patients undergoing allogeneic islet transplant for long-standing T1D. The pilot study resulted in rapid improvement in glycemic control after transplantation, with stable islet graft observed across the entire cohort.

Articles

The first half of 2026 delivered notable endocrine milestones spanning diabetes technology, disease-modifying immunotherapy, and next-generation incretins. FDA actions included pediatric access to inhaled ultra-rapid insulin, clearance of a smaller smartphone-controlled pump, and broadened teplizumab eligibility down to age 1 for stage 2 T1D. Trial updates highlighted durable glucocorticoid-sparing with crinecerfont in classic CAH and substantial weight reduction with retatrutide and CT-388. Clinical insights emphasized earlier ketone detection to prevent DKA and the frequency of post–GLP-1 discontinuation weight regain.

Catch up on key FDA approvals, major trial updates, and critical clinician insights from the last 6 months.

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First Half 2026 Recap - Endocrinology

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.

June brought regulatory setbacks, psychedelic breakthroughs, and a shifting neuromodulation landscape to 

. Cingulate's once-daily ADHD therapy CTx-1301 hit a manufacturing-related snag at the US Food & Drug Administration (FDA), even as its phase 3 data across both adult and pediatric populations held up. Meanwhile, Definium Therapeutics' DT120 reported topline phase 3 results in treatment-resistant major depressive disorder (MDD), with a single dose producing rapid, durable symptom relief through 12 weeks; investigator John Sonnenberg, PhD, said this was unlike anything he's seen in his career.

Elsewhere, TMS is undergoing its own transformation. Accelerated protocols compressing weeks of treatment into days are matching outcomes from the traditional 6-week course, and the FDA's January clearance of the first at-home neuromodulation device for MDD is opening new access points for patients who have long been shut out of standard care by logistics alone.

From CMC-driven delays to compressed dosing schedules, here are 3 psychiatry stories from June 2026 you may have missed.

FDA Issues CRL for CTx-1301 in ADHD Over Manufacturing Concerns

The FDA issued a complete response letter (CRL) for CTx-1301 (dexmethylphenidate HCl), Cingulate's investigational once-daily ADHD treatment, on June 2, 2026, citing Chemistry, Manufacturing, and Controls (CMC) information requests. The agency raised no concerns regarding clinical safety or efficacy.

The decision follows review of 2 pivotal phase 3 trials. In the adult dose-optimization study, 21 participants titrated to doses between 25 mg and 50 mg met the primary PERMP endpoint, with effect sizes ranging from 0.88 to 2.60. In the pediatric fixed-dose trial, children and adolescents aged 6 to 17 years showed dose-dependent improvements on the ADHD-RS-5, with the 37.5 mg dose producing the largest effect. Safety findings in both trials were consistent with the broader methylphenidate class.

CTx-1301 uses a multi-core tablet designed to deliver 3 timed releases over 12 to 16 hours. Cingulate says CMC work is underway, with resubmission as its immediate priority.

Emerge Phase 3: DT120 Shows Rapid, Durable Relief in MDD

Emerge, a phase 3 trial evaluating a single dose of DT120 (lysergide) ODT 100 µg in adults with MDD (aged 18 – 74 years), met its primary endpoint and all key secondary efficacy endpoints, according to topline results announced by Definium Therapeutics on June 22, 2026.

The 149-patient, placebo-controlled study found a placebo-adjusted MADRS reduction of 8.1 points at week 6 (P <.0001), with a 7.3-point difference persisting at week 12. Sonnenberg told 

the durability of response was more clinically meaningful than the early signal alone. Remission rates reached 24% at week 6 versus 3% for placebo.

DT120 ODT was generally well tolerated, with no serious adverse events or suicidality signals reported. Definium's next phase 3 study, Ascend, will include a low-dose arm to address functional unblinding concerns.

TMS for MDD Is Changing Fast. Here's What Psychiatrists Need to Know

TMS has been FDA-cleared for MDD since 2008, but the standard 36-session, 6-to-8-week protocol has long limited access for patients with treatment-resistant depression. That's beginning to change, according to 3 clinician-researchers: Linda Carpenter, MD (Brown), Andrew Leuchter, MD (UCLA), and Scott Wilke, MD, PhD (UCLA).

A March 2026 analysis found that a 5x5 accelerated rTMS regimen produced efficacy comparable to the conventional 6-week course. Leuchter noted that insurance reimbursement for accelerated protocols remains a gap, as Medicare covers only up to 2 sessions per day.

The FDA also approved Neurolief's ProlivRx in January 2026, the first at-home neuromodulation therapy for MDD. In the MOOD trial, ProlivRx achieved a 21.3% remission rate versus 6.0% for sham (

TMS for MDD Reimagined: Faster, Fewer Visits, and Now at Home

June featured divergent inflection points across psychiatry development programs and device-based depression care. An FDA complete response letter stalled CTx-1301’s path in ADHD on CMC deficiencies despite preserved phase 3 efficacy and class-consistent safety. Psychedelic therapeutics advanced with DT120 (lysergide) ODT delivering a single-dose, statistically robust and clinically durable MADRS separation through 12 weeks in treatment-resistant MDD, with favorable tolerability. TMS access barriers are easing via accelerated regimens demonstrating noninferior outcomes to conventional courses and the first FDA-cleared at-home neuromodulation option.

From an ADHD therapy's regulatory setback to a psychedelic's rapid MDD response and TMS's move into patients' homes, here are 3 psychiatry stories from June 2026 you may have missed.

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3 Psychiatry Headlines You Missed in June 2026

The second quarter of 2026 saw an influx of major cardiology news, with the US Food and Drug Administration (FDA) approving some significantly beneficial drugs and a slew of conferences providing key clinician insights into ongoing and completed trials. Everything from heart failure to cardiomyopathy was highlighted over the last 3 months – in fact, an entirely new form of the former was established formally by the Heart Failure Society of America (HFSA) in May.

With things in cardiology moving at a breakneck pace, the editorial team at 

 has collected 9 of the most impactful headlines from the last 3 months. Catch up on any news you may have missed below.

FDA Approves Baxdrostat for Uncontrolled Hypertension on Background Therapy


On May 18, 2026, the FDA approved baxdrostat as an add-on treatment for adults with hypertension inadequately controlled with other antihypertensive agents. Parent company AstraZeneca announced that the decision was based on positive data from the phase 3 BaxHTN trial, which showed substantially greater reductions in mean seated systolic blood pressure in patients treated with baxdrostat compared to placebo.


FDA Approves Olezarsen (Tryngolza) for Severe Hypertriglyceridemia


On June 24, 2026, 6 days ahead of its scheduled PDUFA date, the FDA announced its approval of olezarsen as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adult patients with severe hypertriglyceridemia. This decision makes olezarsen the first therapy approved for this specific indication. The once-monthly, self-administered subcutaneous drug will be available in the US at some point in July, according to the announcement by parent company Ionis.


Mavacamten sNDA Gets FDA Priority Review for Adolescent Obstructive HCM


On June 1, 2026, Bristol Myers Squibb announced the FDA’s acceptance of a supplemental new drug application (sNDA) for mavacamten in adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). A PDUFA target action date of September 30, 2026, was assigned on the same day. Additionally, the FDA granted mavacamten’s sNDA Priority Review status for patients aged 12 to <18 years. If approved, this application would expand mavacamten’s current indication beyond adults with symptomatic oHCM.


ACACIA-HCM: Aficamten Beats Placebo in Non-Obstructive Hypertrophic Cardiomyopathy


Announced on May 5, 2026, by parent company Cytokinetics, aficamten significantly outperformed placebo among patients with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), based on topline data from ACACIA-HCM. The trial saw patients receiving aficamten display substantial improvements in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score and maximal exercise performance compared to placebo recipients.


Asundexian Reduces Stroke Incidence Without Increasing Bleeding, With Ashkan Shoamanesh, MD


The OCEANIC-STROKE trial has displayed asundexian’s significant efficacy in reducing stroke risk among patients who have recently experienced non-cardioembolic stroke or a transient ischemic attack (TIA) without increasing bleeding. Topline results demonstrated that patients in the asundexian group exhibited significantly lower ischemic stroke incidence than the placebo group, with major bleeding incidence similar between both arms. This indicates asundexian’s revolutionary lack of bleeding increase among these patients.


SCOUT-HCM: Mavacamten Outperforms Placebo in Adolescents With HCM, With Joseph Rossano, MD, MS


Presented at ACC 2026 by Joseph Rossano, MD, MS, co-director of the Cardiac Center and chief of the division of cardiology at the Children’s Hospital of Philadelphia, as well as the Jennifer Terker Endowed Chair in Pediatric Cardiology, new data from the SCOUT-HCM trial have demonstrated a greater reduction of left ventricular outflow with mavacamten compared to placebo in patients with obstructive HCM. The ongoing trial also saw adverse events in 18 (78%) patients receiving mavacamten, with only 2 experiencing severe adverse events in both the mavacamten and placebo arms.


Finerenone Efficacy in HF Unchanged by Ischemic Heart Disease, With Jawad Butt, MD, PhD

 at ACC 2026, Jawad Butt, MD, PhD, a research fellow in the department of cardiology at Copenhagen University Hospital and the University of Glasgow, discussed his prespecified analysis of the FINEARTS-HF trial. Finerenone’s beneficial effects were consistent irrespective of ischemic heart disease status in patients with heart failure with mildly reduced or preserved ejection fraction (HFmrEF/HFpEF).


Triple-Combination Blood Pressure Pill Reduces Ischemic Stroke Risk, With Craig Anderson, PhD


Data from the TRIDENT phase 3 trial of GMRx2, a combination of 3 low-dose blood pressure medications into a single pill, substantially reduced stroke risk in patients with intracerebral hemorrhage (ICH). ICH is a direct contributor to a disproportionate percentage of stroke-related morbidity and mortality – among its primary causes is chronic hypertension, which emphasizes the need for blood pressure reduction in these patients to avoid further strokes.


HFmrEF as a Unique Phenotype of Heart Failure, With Jane Wilcox, MD, MSc


The Heart Failure Society of America released in May an official scientific statement recategorizing HFmrEF as an individual, unique phenotype of HF, distinct from HFpEF or HFrEF. The document suggests that clinicians view HFmrEF as all patients with HF and a left ventricular ejection fraction between 40% and 49%. Given the similarity of their structure and symptoms, clinicians agree that HFmrEF is a milder form of HFrEF and

Q2 2026 delivered rapid advances across hypertension, dyslipidemia, cardiomyopathy, stroke prevention, and heart failure. FDA actions included baxdrostat for uncontrolled hypertension, olezarsen as the first therapy for severe hypertriglyceridemia to mitigate pancreatitis risk, and a Priority Review pathway to extend mavacamten into adolescents with obstructive HCM. Phase 3 programs reported positive signals for myosin inhibition in non-obstructive HCM and for factor XIa inhibition lowering recurrent ischemic stroke without excess bleeding. Professional society guidance also formalized HFmrEF as a distinct phenotype.

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

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9 Cardiology Headlines You Missed in Q2 2026

Andrew Bzowyckyj, PharmD, BCPS, CDCES,  is the senior scientific director of Learning Consulting at the National Kidney Foundation. 

The transition from the longstanding Cockcroft-Gault equation to the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation represents a significant shift in how clinicians estimate kidney function for medication-related decision-making. Developed following recommendations from the National Kidney Foundation (NKF) and the American Society of Nephrology (ASN), the 2021 CKD-EPI equation removes race as a variable and is increasingly being adopted by clinical laboratories across the United States.

To discuss the rationale behind the transition, implementation considerations, and practical implications for clinicians, HCPLive spoke with Andrew Bzowyckyj, PharmD, BCPS, CDCES, senior scientific director of Learning Consulting at the National Kidney Foundation, about the evolution of kidney function estimation and what healthcare professionals should know as eGFR-based medication decision-making becomes more widely integrated into clinical practice.

Can you explain the history of the Cockcroft-Gault equation and what has driven the transition toward the 2021 CKD-EPI equation?

 The Cockcroft-Gault equation was developed in 1976 to estimate creatinine clearance and was validated in 249 White men. Women were not included in the original validation cohort, and an empiric adjustment was later added based on body size and muscle mass. For decades, that equation became the standard for informing medication dosing in patients with kidney impairment.

At the same time, nephrology was moving toward estimating glomerular filtration rate for chronic kidney disease diagnosis and staging, first with the MDRD equation and later with the CKD-EPI equations.

Today, the 2021 CKD-EPI equation provides an estimate of glomerular filtration rate without incorporating race. Our workgroup's goal is to bridge the historical divide between medication dosing, which has relied on Cockcroft-Gault, and broader medical decision-making, which has relied on eGFR.

We feel clinicians should begin with the best available estimate of a patient's kidney function and then incorporate other patient-specific factors when making medication decisions. The Cockcroft-Gault equation was developed before standardized creatinine assays were widely used, so current eGFR equations better reflect modern clinical practice.

: Beyond removing race, what improvements were made in the 2021 CKD-EPI equation, and what has adoption looked like so far?

 Removing race from the equation was a major step forward because race is not a binary variable. Eliminating it removes a level of subjectivity from estimating kidney function.

The equation was also developed using much larger and more diverse patient populations, with more than 8000 patients in the derivation cohort and another 4000 in the validation cohort. That provides a much more robust foundation than earlier equations.

We've seen broad adoption, with about two-thirds of clinical laboratories transitioning to the newer race-free equation. Some laboratories are still working through implementation barriers, including software updates and workflow changes.

From a medication standpoint, having one eGFR result for all patients simplifies clinical decision-making because clinicians no longer have to determine which estimate to use based on race.

: What should clinicians know as they begin using eGFR for medication-related decisions?

 This represents a significant change in practice after decades of relying on Cockcroft-Gault for medication dosing. One important point is that the eGFR reported by the laboratory is standardized to a body surface area of 1.73 m². For medication decisions, clinicians should adjust that value to the patient's actual body surface area because medications are cleared based on an individual's kidney function.

One of our goals at the National Kidney Foundation is to work with electronic health record vendors so these calculations can be automated and presented in a way that's easy for clinicians to use while still allowing them to verify the underlying patient data.

It's also important to remember that every kidney function equation is an estimate. Regardless of which equation is used, the result should serve as a starting point. Clinicians still need to consider the individual patient and other clinical factors when making medication decisions.

Editor’s Note: Bzowyckyj reports no relevant disclosures. 
References

Bzowyckyj AS, Nolin TD, Stevens LA, et al. Recommendations for use of the 2021 CKD-EPI creatinine equation for medication-related decision-making. 

 2025;86(5):671-682. doi:10.1053/j.ajkd.2025.05.010 

Inker LA, Eneanya ND, Coresh J, et al. New creatinine- and cystatin C-based equations to estimate GFR without race. 

 2021;385(19):1737-1749. doi:10.1056/NEJMoa2102953

Cockcroft–Gault, derived in 1976 from 249 White men and later modified empirically for women, long anchored renally adjusted dosing despite pre–standardized creatinine assays. Contemporary practice is shifting to the 2021 CKD-EPI creatinine equation, developed in larger, more diverse cohorts and eliminating race to reduce subjectivity and harmonize kidney assessment across care decisions. Adoption is broad across US laboratories. For medication use, laboratory-reported eGFR (indexed to 1.73 m²) should be de-indexed to patient BSA and interpreted as an estimate alongside clinical context.

Andrew Bzowyckyj, PharmD, explains the transition to the 2021 CKD-EPI equation and its implications for medication decisions.


The Shift to the 2021 CKD-EPI Equation for Medication Decision-Making

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.

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.

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8 Pulmonology Headlines you Missed in Q2 2026

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

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

FDA News Recap: Novel Drug Approvals in Q2 2026

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

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

Videos

9 Endocrinology Headlines You Missed in Q2 2026

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.

Allergy First Half Recap: 2026

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.

Conference

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

How Should Dermatology Clinicians Address Online Myths? With Shannon Trotter, DO

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

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.

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

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.

Cardiomyopathy

6 Cardiology Headlines You Missed in June 2026

This FDA News Month in Review provides a round-up of regulatory decisions from June 2026.

Latest News

First Half 2026 Recap - Endocrinology

3 Psychiatry Headlines You Missed in June 2026

9 Cardiology Headlines You Missed in Q2 2026

The Shift to the 2021 CKD-EPI Equation for Medication Decision-Making

8 Pulmonology Headlines you Missed in Q2 2026