Physician and CEO, Chicago Allergy Center, and board director at American Lung Association

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

The FDA's April 28, 2026 approval of budesonide/glycopyrrolate/formoterol fumarate (BGF; Breztri Aerosphere, AstraZeneca) for 

 maintenance in patients aged 12 years and older marks the first time a single-inhaler triple combination therapy has been available in the United States for this indication.

caught up with Juanita Mora, MD, an allergist-immunologist at Chicago Allergy Center, attending physician at Advocate Illinois Masonic Medical Center in Chicago, Illinois, and board director of American Lung Association, to learn more about the approval, which she sees as an overdue expansion of options for a large and underserved patient population.

BGF combines budesonide, an inhaled corticosteroid (ICS), with formoterol fumarate, a long-acting β₂-agonist (LABA), and glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered via pressurized metered-dose inhaler using AstraZeneca's Aerosphere co-suspension technology. The addition of the LAMA to the established ICS/LABA backbone provides a complementary bronchodilatory mechanism through anticholinergic airway smooth muscle relaxation, addressing both the inflammatory and obstructive components of asthma in a single device. Breztri was previously approved for chronic obstructive pulmonary disease (COPD) in adults in July 2020, giving the regimen a substantial real-world safety and efficacy track record — a feature Mora noted provides additional confidence as the drug transitions into the asthma setting.

The approval was supported by data from the KALOS and LOGOS trials, twin phase 3, randomized, double-blind, double-dummy, multicenter studies enrolling approximately 4,300 patients with asthma inadequately controlled on medium- or high-dose ICS/LABA therapy, with treatment durations of 24 to 52 weeks. The least squares mean differences in morning pre-dose trough FEV₁ and FEV₁ AUC₀₋₃ over 24 weeks for BGF 28.8 μg versus the pooled budesonide–formoterol comparators were 76 mL (95% CI, 57–94; 

 <.0001), respectively. In the primary pooled exacerbation analysis, BGF 28.8 μg reduced the annualized severe exacerbation rate versus the combined budesonide–formoterol arms (incidence rate ratio, 0.86; 95% CI, 0.76–0.97; 

 = .012) and versus the suspension formulation specifically (IRR, 0.82; 95% CI, 0.71–0.94; 

 = .0043). Investigators noted that benefits were observed regardless of recent exacerbation history, suggesting BGF may be appropriate for escalation without requiring a preceding acute episode on ICS/LABA. The most common adverse events were nasopharyngitis, pneumonia, and headache; no treatment-related deaths occurred.

Mora framed the clinical significance of the approval around access as much as mechanism. An estimated 27 million Americans have asthma, with a substantial proportion — representing as many as half of those on existing inhaled maintenance therapy — remaining inadequately controlled on dual ICS/LABA regimens. For patients in that group who have not yet been able to see a specialist and initiate biologic therapy, BGF provides an additional pharmacologic option within the inhaled maintenance category that can be initiated and managed in primary care or general allergy settings. She emphasized this pathway as especially relevant for Hispanic and other underserved communities with limited specialty access, a patient population she serves directly in Chicago and one she has described as bearing a disproportionate burden of poorly controlled asthma.

“I think it's going to really especially for patients who maybe don't have as much access to a specialist where they can get a biologic,” Mora said. “[It’s] a wonderful option to open the doors for better control of our asthmatics.”

Mora has no relevant disclosures to report.

AstraZeneca. FDA approves BREZTRI AEROSPHERE® (budesonide/glycopyrrolate/formoterol fumarate) for asthma. Press release. April 28, 2026.

Bateman ED, O'Byrne PM, Rabe KF, et al. Budesonide/glycopyrronium/formoterol fumarate dihydrate versus budesonide/formoterol in patients with inadequately controlled asthma (KALOS and LOGOS): two multicentre, randomised, double-blind, double-dummy, phase 3 studies. 

. 2026. doi:10.1016/S2213-2600(25)00457-6

Videos

The first single-inhaler ICS/LABA/LAMA combination for asthma adds a mechanistically distinct bronchodilator to a well-established inhaled backbone.

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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.

 was defined by regulatory expansion, early-stage innovation, and emerging questions around how patients access mental health care. The US Food and Drug Administration (FDA) expanded the label for lumateperone (Caplyta) to include relapse prevention in schizophrenia. A White House executive order accelerated psychedelic research through coordinated action with the FDA and Drug Enforcement Administration (DEA), while clinical trials advanced rapid-acting and mechanism-driven approaches such as GH001. At the same time, increasing reliance on ChatGPT for mental health guidance raised new ethical and clinical oversight concerns for psychiatrists.

This month in review spotlights the 5 top psychiatry news stories in April 2026.

FDA Update: Extended Lumateperone Label for Schizophrenia

Lumateperone sNDA Approved with Relapse Prevention Data in Schizophrenia

The FDA approved a supplemental New Drug Application (NDA) for lumateperone, expanding its schizophrenia label to include relapse prevention. In the randomized withdrawal phase 3 trial, patients stabilized on lumateperone 42 mg had a 63% lower relapse risk versus placebo (HR, 0.37; 

 =.0002), with 84% remaining relapse-free at 6 months. Johnson & Johnson reported favorable time to relapse and discontinuation outcomes.

White House Push for Psychedelic Research

White House Order Accelerates Psychedelic Research for Mental Illness, With Gus Alva, MD

A White House executive order signed by Donald Trump on April 18, 2026, directs the FDA and DEA to accelerate psychedelic research for serious mental illness, including breakthrough therapy pathways, national priority vouchers, and ≥ $50 million in federal funding. In an 

 interview, Gus Alva, MD, of ATP Clinical Research, highlighted 5-HT2A–mediated neuroplasticity and models such as REBUS as potential mechanisms. Evidence from psilocybin (TRD) and MDMA (PTSD) trials shows promise, though blinding challenges, safety risks, and psychotherapy confounders remain key limitations.

Your Patient's New Therapist Is an AI. Now What?

As patients increasingly use ChatGPT for mental health advice, psychiatrists and ethicists warn of clinical and ethical risks. Richard Miller (Elwyn Adult Behavioral Health) noted AI may deliver decontextualized or misleading guidance, while Dominic Sisti (University of Pennsylvania) raised concerns about self-harm queries, privacy, and the need for guardrails. Darlene King (University of Texas Southwestern Medical Center) likened AI advice to that of an uninformed friend.

Despite risks, AI tools show promise in screening, biomarker-guided treatment, and documentation. Experts recommend clinicians proactively discuss AI use and maintain a “human-in-the-loop” approach.

Patients Bring ChatGPT to Psychiatry Visits, With Richard Miller, MD

AI in Psychiatry Raises Ethics Questions With Dominic Sisti, PhD

Single-Day GH001 for TRD Shows Rapid Response, With Michael E. Thase, PhD

In a phase 2b trial, single-day inhaled GH001 demonstrated rapid, clinically meaningful antidepressant effects in treatment-resistant depression (TRD), with significant MADRS improvement by day 8 (−15.5; 

<.001) and 57.5% remission vs 0% with placebo. In an 

 interview, Michael E. Thase (Perelman School of Medicine at the University of Pennsylvania) highlighted GH001’s individualized, single-day dosing (6 mg, 12 mg, 18 mg) and rapid onset within 1 week.

Effects were short-lived (9-14 minutes), with outpatient feasibility. Safety was favorable, with no serious adverse events. Durability data suggest intermittent retreatment approximately every 6 weeks may maintain response.

Kv7 Channel Modulator Azetukalner May Improve Anhedonia, With James Murrough, MD, PhD

At the Anxiety and Depression Association of America (ADAA) 2026 meeting, phase 2 data showed the Kv7 channel opener azetukalner may improve anhedonia in major depressive disorder (MDD) despite missing its primary neuroimaging endpoint. In the randomized trial (n = 60), ventral striatal activation did not differ from placebo, but MADRS and SHAPS outcomes numerically favored azetukalner with low discontinuation rates. James Murrough (Icahn School of Medicine at Mount Sinai) emphasized Kv7 (KCNQ) channels as targets for reward circuitry and stress resilience.

Articles

Regulatory momentum and early clinical innovation shaped April 2026 psychiatry developments. Lumateperone gained an FDA label expansion for schizophrenia relapse prevention, supported by a randomized-withdrawal phase 3 hazard ratio of 0.37 versus placebo. Federal action also intensified interest in psychedelics, outlining FDA/DEA coordination, expedited pathways, and dedicated funding while highlighting unresolved trial-design and safety challenges. Concurrently, patient use of generative AI for mental health guidance prompted calls for guardrails and clinician engagement. Phase 2 signals for GH001 and azetukalner suggested rapid antidepressant and anhedonia effects.

FDA expands lumateperone for relapse prevention in schizophrenia, White House boosts psychedelics research, and AI reshapes psychiatry care debates in April 2026.

Psychiatry

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.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

5 Psychiatry Headlines You Missed in April 2026

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.

April 2026 was a consequential month for pulmonology, defined above all by the continued consolidation of tozorakimab's phase 3 program and a regulatory milestone that reshapes the inhaled therapy landscape in 

. AstraZeneca's IL-33 inhibitor added a third positive pivotal trial to its LUNA program with the MIRANDA readout, which tested the drug on a more frequent 2-week dosing interval and extended the exacerbation reduction signal to former and current smokers alike, regardless of eosinophil level or lung function severity — a population breadth that separates it mechanistically from the type 2–restricted biologics that currently dominate chronic obstructive pulmonary disease (COPD) prescribing. LUNA program chief investigator Frank Sciurba, MD, joined 

 to contextualize the results and explain why the IL-33 pathway's dual-form inhibition may address COPD drivers that prior biologics cannot reach.

On the asthma side, the month closed with the FDA approval of budesonide/glycopyrrolate/formoterol fumarate (BGF; BREZTRI Aerosphere) as the first single-inhaler ICS/LABA/LAMA triple combination for patients aged 12 and older — a decision grounded in the phase 3 KALOS and LOGOS data published in 

, which showed a pooled 76 mL improvement in trough FEV₁ and a reduction in severe exacerbations over dual therapy. The approval arrives alongside growing pipeline momentum: Sanofi's bispecific lunsekimig, targeting both TSLP and IL-13, posted positive phase 2 results across asthma and chronic rhinosinusitis with nasal polyps earlier in the month, though a concurrent atopic dermatitis study missed its primary endpoint — a mixed but directionally encouraging readout for a mechanism that could eventually offer a single-agent alternative to sequential biologic escalation.

Check out this April 2026 pulmonology month in review for a recap of HCPLive's coverage of the top news and research from the past few weeks:

FDA Approves BGF Triple Therapy for Asthma in Patients 12 and Older

The FDA approved budesonide/glycopyrrolate/formoterol fumarate (BREZTRI Aerosphere; AstraZeneca) on April 28 as the first single-inhaler fixed-dose triple-combination maintenance therapy for asthma in patients aged 12 years and older, marking the drug's second approved indication following its 2020 clearance for COPD. The approval was supported by the phase 3 KALOS and LOGOS trials, in which BGF demonstrated statistically significant improvements in trough FEV₁ and FEV₁ AUC₀₋₃ over dual ICS/LABA therapy at 24 weeks, along with reductions in severe exacerbation rates.

Lunsekimig Meets End Points in Asthma and CRSwNP, Misses in Atopic Dermatitis

Sanofi's lunsekimig, a bispecific Nanobody construct targeting both TSLP and IL-13, met its primary and key secondary endpoints in the phase 2b AIRCULES trial in moderate-to-severe asthma and in the phase 2a DUET trial in chronic rhinosinusitis with nasal polyps, though it did not meet its primary endpoint in the exploratory phase 2b VELVET study in atopic dermatitis. Full efficacy data from all 3 studies have not yet been disclosed, and Sanofi has characterized respiratory indications as the primary development focus, with 2 phase 3 COPD trials and a high-risk asthma study currently underway.

BGF Triple Therapy Improves Lung Function in Phase 3 Uncontrolled Asthma Controls

Full results from the phase 3 KALOS and LOGOS trials, published in 

, showed that BGF 320/28.8/9.6 µg improved trough FEV₁ by a pooled least squares mean of 76 mL (95% CI, 57–94 mL; 

 <.001) and FEV₁ AUC₀₋₃ by 90 mL over dual ICS/LABA at 24 weeks in patients with asthma inadequately controlled on medium- or high-dose ICS/LABA therapy. Benefits in lung function and severe exacerbation reduction were observed regardless of prior exacerbation history across the approximately 4,300 randomized patients, supporting BGF as a viable escalation option before or independent of a preceding acute episode.

Phase 3 MIRANDA: Tozorakimab Reduces COPD Exacerbations

AstraZeneca announced April 20 that tozorakimab met its primary endpoint in the phase 3 MIRANDA trial, reducing the annualized rate of moderate-to-severe COPD exacerbations compared with placebo in former smokers and in the overall population — including current smokers across all eosinophil levels and lung function severity stages — with patients receiving 300 mg subcutaneously every 2 weeks on top of inhaled standard of care. The result marks the third consecutive positive phase 3 readout in the LUNA program, extending the exacerbation reduction signal from OBERON and TITANIA to a more frequent dosing regimen and further consolidating the evidence base ahead of anticipated regulatory submissions.

Reducing COPD Exacerbations With Tozorakimab, With Frank Sciurba, MD

Frank Sciurba, MD, professor of Pulmonary and Critical Care Medicine at the University of Pittsburgh and chief investigator of the LUNA program, discussed the clinical significance of tozorakimab's positive phase 3 program, explaining that the IL-33 inhibitor's unique ability to block both the reduced and oxidized forms of IL-33 positions it to address type 1, 2, and non-type 2 inflammatory pathways simultaneously — a mechanistic distinction from existing COPD biologics that require eosinophilic phenotyping. Sciurba noted that up to half of patients with COPD continue to experience exacerbations on standard inhaled therapy, underscoring the magnitude of the unmet need that a biomarker-agnostic agent could begin to address pending regulatory review.

April 2026 highlighted two major pulmonary inflection points: expansion of IL-33 inhibition in COPD and the first FDA-cleared single-inhaler triple therapy for asthma. Tozorakimab delivered a third positive phase 3 result in MIRANDA, extending exacerbation reduction to broad COPD subgroups including current smokers, independent of eosinophils and lung-function severity, on a q2w regimen. In asthma, FDA approved budesonide/glycopyrrolate/formoterol (BGF) for patients ≥12 years, supported by KALOS/LOGOS lung-function gains and fewer severe exacerbations. Sanofi’s bispecific lunsekimig showed phase 2 respiratory efficacy despite an atopic dermatitis miss.

April 2026 saw new data from pivotal clinical trials and a new approval in asthma.

Asthma

The HCPLive asthma page is a comprehensive resource for clinical news and insights on asthmatic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for allergic and severe asthma, and more.

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5 Pulmonology Headlines You Missed in April 2026

Growth Hormone Deficiency in Cancer Survivors 

In the final episode, the panel addresses one of the most clinically complex and emotionally charged questions in GHD management: when and how to initiate or resume GH therapy in patients with a history of malignancy.

Dr. Agrawal poses the question of GH use in the setting of active or recent malignancy, noting that in adult practice, the standard approach is to wait at least 5 years post-remission before initiating GH — with a multidisciplinary decision involving the oncology team. One exception is non-melanoma skin cancers, which are considered lower-risk for GH-related stimulation.

Dr. Alter explains the pediatric approach, which is institution-dependent and individualized. At Children’s Hospital of Philadelphia, for non-craniopharyngioma malignancies (e.g., germ cell tumors), the team waits 2 years from tumor stability, documents neuro-oncology consensus, and monitors with MRI at 6-month intervals. For craniopharyngiomas, evidence now supports initiating GH as early as 6 months post-treatment, given that no excess tumor recurrence risk has been observed. Age matters: a 3-year-old has more time to wait; a 14-year-old in a critical growth window may not.

Dr. Garcia frames the informed consent conversation for adult cancer survivors: patients must understand that having a prior malignancy (and its treatments, including radiation) already elevates the risk of secondary cancers — and that current data do not show GH adding further risk beyond that baseline. However, these conversations must acknowledge genuine uncertainty, and patients must be active partners in the decision.

Thank you for watching this HCP Live Peer Exchange series on growth hormone deficiency. Please subscribe to our eNewsletter for information on upcoming video series.

Experts debate when to start growth hormone after cancer, share pediatric vs adult wait times, and offer tips on long‑acting GH dosing.

Growth Hormone Deficiency in Cancer Survivors

Navigating Barriers in Adult GHD Management

This episode focuses on the real-world access challenges that clinicians and patients with adult GHD face — including insurance denials, documentation requirements, and strategies for obtaining and sustaining GH therapy approvals.

Dr. Agrawal opens with a frank observation: insurance companies frequently do not understand adult GHD. The term “growth hormone” creates conceptual confusion for payers who associate GH exclusively with childhood height. She suggests that adult GHD might benefit from reframing — as a metabolic disease, for example — to help payers understand its systemic and long-term health implications. Until then, comprehensive documentation aligned with FDA indications and clinical guidelines remains the clinician’s primary tool.

Practical documentation strategies discussed by the panel include: citing FDA-approved indications explicitly in clinical notes, including all pediatric GH history and testing when available, compiling a complete prior authorization package that tells a coherent clinical narrative, and in some cases requiring patients to demonstrate failure on daily GH before gaining insurance approval for weekly analogs.

Dr. Garcia underscores that a formal transition clinic would be the ideal solution for documentation continuity — with all records centralized and specialists from both sides co-present. He confirms that most of his transitioning patients arrive with adequate prior testing in place, reducing the need for complete retesting.

The episode closes with a broader discussion on optimizing long-term adult GHD care. Dr. Garcia stresses the value of patient engagement: understanding what matters to each patient — whether fatigue, mood, body composition, or general wellbeing — and framing treatment goals around those priorities dramatically improves adherence. Dr. Yang reinforces that GHD is not simply a growth condition that ends in adulthood; some of the most serious metabolic and skeletal consequences can emerge or worsen in adult years.

,” the panel tackles GH use in patients with active or prior malignancy.

Insurance barriers and missing records complicate adult growth hormone therapy, as experts urge better documentation, transition clinics, and patient-centered care to improve outcomes.

How pediatric endocrinologists evaluate poor growth: key labs, IGF-1/IGFBP-3, stimulation testing, and ruling out celiac, Crohn’s, thyroid disease.

Growth Hormone Deficiency in Adults — Presentation, Quality of Life, and Diagnostic Challenges

Examining the 2026 ACC/AHA Dyslipidemia Guidelines for ASCVD

ASCVD Risk Assessment and LDL-C Management

FDA updates, phase 3 CRISPR data in HAE, and emerging food allergy prevention strategies defined allergy and immunology news in April 2026.

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Food Allergy

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5 Allergy Headlines You Missed in April 2026

Learn how clinicians evaluate poor growth in kids—key labs, IGF‑1 clues, stimulation tests, and ruling out celiac, Crohn’s, thyroid issues.

Diagnosing Growth Hormone Deficiency in Children — Testing, Tools, and Decision-Making

Maria Hordinsky, MD, is an R.W. Goltz Professor of the Department of Dermatology at the University of Minnesota.

In this Q&A interview, Hordinsky was asked about recent 1-year data on clascoterone solution 5% in androgenetic alopecia (AGA).

Alopecia

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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.

Q&A: 1-Year Efficacy Data on Clascoterone 5% in Androgenetic Alopecia, With Maria Hordinsky, MD

Archana Sadhu, MD, is the director of transplant endocrinology, pancreas transplantation, and the system diabetes program at Houston Methodist.

Sadhu provides an update on the state of the stem cell and islet cell therapy landscapes, highlighting encouraging developments in insulin independence.

Endocrinology

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Type 1 Diabetes

Conference

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Advances and Shortcomings in Cell Therapy for Type 1 Diabetes, With Archana Sadhu, MD

Pranav Garimella, MBBS, MPH, is chief medical officer of the American Kidney Fund.

Garimella, MBBS, unpacks what clinicians need to know about APOL1-mediated kidney disease, including misclassification, testing barriers, and management gaps. 

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.

Beyond Hypertensive Nephrosclerosis: A Closer Look at APOL1-Mediated Kidney Disease

Abigail Brooks is an assistant managing editor for 

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

IBS care is evolving with personalized, multimodal strategies, but gaps in access, education, and real-world outcomes continue to impact patients’ lives

Gastroenterology

Gastroenterology condition center page is a comprehensive resource for clinical news and insights on digestive and GI conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for 

, IBS and IBD, Crohn's disease, and more.

Irritable Bowel Syndrome

On the HCPLive irritable bowel syndrome page, resources on the topics of medical news and expert insight into IBS can be found. Content includes articles, interviews, videos, podcasts, and breaking news on IBS, IBD, and more.

Navigating Progress, Personalization, and Persistent Gaps in IBS Care

Are IL-23 inhibitors, rather than IL-17 inhibitors, the preferred biologic for psoriasis patients at risk of developing psoriatic arthritis?

Plaque Psoriasis

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

Latest News

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

5 Psychiatry Headlines You Missed in April 2026

5 Pulmonology Headlines You Missed in April 2026

Growth Hormone Deficiency in Cancer Survivors

Navigating Barriers in Adult GHD Management