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

Articles

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

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 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.

Cardiology

Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

Dyslipidemia

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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

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.

FDA News

Dermatology

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

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Ophthalmology

Ophthalmology page, resources on the topics of medical news and expert insight into ophthalmic disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on eye disease research, treatment, and drug development.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This page also hosts content previously published by EndocrinologyNetwork. 


Nephrology

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

Type 1 Diabetes

Type 2 Diabetes

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

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

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

FDA News Recap: Novel Drug Approvals in Q2 2026