Chelsie Derman is an associate editor for 

who covers allergy and  psychiatry. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

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

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

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

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

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

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

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

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

New international consensus clarifies when to administer epinephrine for anaphylaxis

FDA Approves Dupilumab (Dupixent) for Allergic Fungal Rhinosinusitis

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

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

FDA Approves Oral Berotralstat (Orladeyo) for Pediatric HAE

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

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

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

FDA Removes Age Restriction for Epinephrine Nasal Spray (Neffy)

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

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

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

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

FDA Accepts NDA for Bezuclastinib in Non-Advanced Systemic Mastocytosis

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

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

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

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

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

Updated Guidelines in HAE & Epinephrine Use

Pediatric HAE Guideline Recommends Sebetralstat as First-Line Therapy

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

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

Updated Anaphylaxis Guidelines, Early Management Priorities

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

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

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

Articles

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

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

News

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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.

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

Society of Dermatology Physician Associates (SDPA) 2026 Annual Summer Dermatology Conference

 in Denver, Colorado, HCPLive’s editorial staff spoke in an interview with Shannon Trotter, DO, FAOCD, a board-certified dermatologist and skin cancer specialist with DOCS Dermatology and the Dermatologists of Central States in Ohio.

Trotter had presented a session titled "Mythbusters in Dermatology: Helpful, Harmful, or Hype."

, Trotter spoke about increases in dermatologic misinformation, why those seen in practice as patients are increasingly turning to social media for medical advice, and how clinicians can respond.

“There's just so much going on, especially online, about what patients hear about and what they think is truly fact and what we know is probably fiction,” Trotter expressed. “So, they come into the office with already an idea of how they want to be treated or their diagnosis, and I think that that's a good thing that people are more engaged in their health care. But the downside is some of those things could actually be hurtful for the patient.”

Although Trotter did acknowledge that increases in patient engagement in health care is broadly-speaking a positive development, she cautioned against some of the information driving this form of engagement. Trotter noted such misinformation is not only inaccurate but could even be dangerous, given the wide spectrum of myths patients bring into practices. 

On the more benign end of misinformation are longstanding folk remedies, Trotter stated, including the belief that applying toothpaste to a pimple will resolve it. In terms of concerning claims, Trotter pointed to the assertion that sunscreen causes skin cancer. This misconception, she stated, is particularly serious given the implications for skin cancer prevention in clinical practice.

Trotter cited a set of 3 converging factors leading to patients’ finding of misinoformation: convenience, entertainment value, and eroding trust in the medical system. She highlighted social media’s accessibility without an appointment, as it allows information in short, engaging formats to exist. In research she referenced, it is sometimes even trusted by some more than their own providers. This is a dynamic Trotter referred to as the most troubling aspect of the current landscape.

Among those seeking to counter misinformation, Trotter urged leading with evidence-based information. She also encouraged taking time to validate patients' views and fears, recognizing what drew them to a particular source or idea regarding treatment. Creating space for such a conversation, she posited, is essential to rebuilding trust and steering those who may have been led astray toward safer, data-supported care.

Trotter reported no financial disclosures of note.

Trotter S. Mythbusters in Dermatology: Helpful, Harmful, or Hype? Session presented at SDPA Summer 2026; June 10–14.

Videos

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

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.

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

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

Explore the heterogeneity of pediatric functional constipation and IBS-C, the limitations of one-size-fits-all algorithms, and the importance of integrating dietary, behavioral, and psychosocial interventions alongside pharmacologic therapy.

Despite the availability of numerous therapies, many children with functional constipation or IBS-C remain dissatisfied with treatment outcomes, revealing persistent gaps in standard management strategies. Julie Khlevner, MD, attributes these challenges to the heterogeneity of disorders of gut–brain interaction, which often involve comorbid conditions, refractory symptoms, extraintestinal manifestations, and significant impacts on quality of life. In her view, linear, one-size-fits-all algorithms frequently underperform in this context, because they do not fully account for the diverse symptom drivers and multifactorial pathophysiology present in individual patients.

To address this complexity, Khlevner highlights the value of a multidimensional, biopsychosocial approach. For functional constipation, she describes combining pharmacologic and nonpharmacologic treatments to create predictable, comfortable stooling patterns while simultaneously targeting behavioral contributors such as withholding and dysfunctional toileting. Practical behavioral strategies—including scheduled toilet sitting, proper positioning, and reinforcement techniques—are paired with individualized dietary recommendations that focus on age-appropriate fiber intake and hydration and on identifying specific dietary triggers, without resorting to overly restrictive or burdensome diets.

Khlevner also underscores the importance of psychosocial and lifestyle factors, including stress, coping patterns, social media use, and sleep, which can influence symptom severity and responsiveness to interventions in both functional constipation and IBS-C. When indicated, she incorporates behavioral health support such as cognitive behavioral therapy and gut-directed interventions, particularly for patients with marked pain amplification or hypervigilance. Although she acknowledges that access to interdisciplinary care remains a significant challenge, she views integrated models that bring together medical, dietary, and behavioral expertise as critical for optimally managing pediatric disorders of gut–brain interaction.

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

Video Series

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.

 management to new glomerular disease data and a regulatory update from the

, June delivered several notable developments in 

Katherine Tuttle, MD, discussed how the "pillared approach" is reshaping CKD care, while Javed Butler, MD, MBA, explored the value of albuminuria in heart failure risk assessment. The month also featured late-breaking TURING trial results evaluating rituximab in minimal change disease and focal segmental glomerulosclerosis (FSGS), as well as an FDA Complete Response Letter for oxylanthanum carbonate in patients with CKD on dialysis.

Here are 4 nephrology headlines you may have missed in June 2026:

Q&A: The Pillared Approach and Reframing Goals of CKD Care, With Katherine Tuttle, MD

Katherine Tuttle, MD, professor of medicine and executive director for research at Providence Healthcare, spoke with HCPLive at the 10th Annual Heart in Diabetes meeting about the evolving “pillared approach” to CKD management and how it is reframing treatment goals in clinical practice.

Over the past several years, a pillared approach to CKD management has gained traction across the field, incorporating renin-angiotensin-aldosterone system inhibition, SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists. Each targets distinct but overlapping pathways, including hemodynamic dysfunction, metabolic dysregulation, inflammation, and fibrosis.

The Value of Albuminuria in Heart Failure Risk Assessment, with Javed Butler, MD, MBA

 Javed Butler, MD, MBA, president of the Baylor Scott & White Research Institute, discussed the role of albuminuria in heart failure risk assessment and whether urine albumin-to-creatinine ratio (UACR) could serve as a future therapeutic monitoring target.

He also addressed when clinicians should act on elevated albuminuria and how it may refine cardiovascular risk stratification in patients with metabolic disease.

Kidney Compass: Rituximab Cuts Relapse Risk in MCD, FSGS in TURING Trial

In this episode of Kidney Compass, host Brendon Neuen, MBBS, PhD, spoke with Lisa Willcocks, MBBChir, MRCP, PhD, consultant nephrologist at Addenbrooke’s Hospital in Cambridge, United Kingdom, about late-breaking data from the TURING trial presented at the European Renal Association (ERA) Congress in Glasgow, Scotland.

The findings showed rituximab was associated with reduced relapse risk in adults with minimal change disease (MCD) and FSGS, offering new prospective evidence for its role in primary glomerular disease management.

FDA Issues CRL for Oxylanthanum Carbonate in Hyperphosphatemia for CKD Patients on Dialysis

On June 30, 2026, the FDA issued a CRL to Unicycive Therapeutics for oxylanthanum carbonate in the treatment of hyperphosphatemia in patients with CKD on dialysis.

The agency cited deficiencies at a third-party manufacturing vendor. The company noted the FDA inspection of the facility did not occur during the New Drug Application (NDA) resubmission review. No concerns were raised regarding clinical efficacy or safety data, and no additional data were requested.

June nephrology updates emphasized a multidimensional CKD “pillared approach” integrating RAAS blockade, SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists to address hemodynamic, metabolic, inflammatory, and fibrotic pathways. Albuminuria (UACR) was highlighted as a potentially actionable marker to refine heart failure risk stratification and possibly monitor therapy in metabolic disease. Late-breaking TURING trial results provided prospective evidence that rituximab reduces relapse risk in adult minimal change disease and FSGS. Separately, the FDA issued a Complete Response Letter for oxylanthanum carbonate due to manufacturing vendor deficiencies.

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

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

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.

The first half of 2026 brought a wave of innovation across the medical community, with 22 novel drug approvals signaling major strides in disease treatment and management across a wide range of specialties.

From new options in oncology, including therapies for breast cancer, ovarian cancer, and mantle cell lymphoma, to groundbreaking advances in rare and ultra-rare diseases like Menkes disease, Hunter syndrome, and Arginase 1 Deficiency, this wave of approvals underscores the growing precision and diversity of today's therapeutic landscape. Several approvals also opened doors in historically underserved areas, including chronic hepatitis delta virus infection, thyroid eye disease, and once-weekly basal insulin dosing. Together, these developments signal not just short-term progress, but a promising trajectory for the rest of 2026 and for the future of patient care across specialties.

To celebrate the first half of 2026, we have compiled a recap for each of the 22 novel drug approvals from January through June, including links to related coverage from 

 and other brands within the MJH Life Sciences family of brands, including 

: Approval supported by data from 2 completed open-label, single-arm, single-site studies in which 129 patients with Menkes disease were treated with copper histidinate, formerly known as CUTX-101. In the studies, treatment consisted of subcutaneous administration of copper histidinate (1450 μg, equivalent to 250 μg elemental copper) twice daily until aged 12 months and once daily thereafter, for a total treatment duration of up to 3 years

FDA Approves Subcutaneous Copper Histidinate as First Treatment for Pediatric Menkes Disease

: To treat mild to moderate atopic dermatitis

: Approval supported by phase 3 clinical trial data in adult and pediatric patients with mild to moderate AD. Patients applying difamilast ointment twice daily achieved statistically significant improvements in Investigator’s Global Assessment (IGA) scores—the primary end point—vs vehicle at week 4, with a meaningful proportion achieving IGA 0 (clear) or 1 (almost clear) with at least a 2-grade improvement from baseline. Secondary endpoints, including Eczema Area and Severity Index scores and patient-reported pruritus, also favored difamilast, with itch reductions observed early in treatment.

FDA Approves Difamilast as New Topical PDE4 Inhibitor for Atopic Dermatitis

: To treat schizophrenia and to treat manic or mixed episodes associated with bipolar I disorder

: Approval supported by bioequivalence data and the existing clinical database for iloperidone, which was already approved for schizophrenia and manic or mixed episodes associated with adult bipolar I disorder.

FDA Approves Milsaperidone for Acute Bipolar I Disorder, Schizophrenia

: To treat hyperarginemia in adults and pediatric patients two years and older with Arginase 1 Deficiency, in conjunction with dietary protein restriction

: Approval supported by data from the multicenter, randomized, double-blind, placebo-controlled phase 3 PEACE trial (NCT03921541). At 24 weeks, pegzilarginase produced a significant reduction in plasma arginine levels compared with placebo, lowering geometric mean levels from 354.0 to 86.4 μmol/L and normalizing plasma arginine in 90.5% of treated patients, whereas no normalization was observed in the placebo group.

FDA Grants Accelerated Approval to Pegzilarginase for Arginase 1 Deficiency

: To increase linear growth in pediatric patients 2 years and older with achondroplasia with open epiphyses

: Approval supported by data from 3 randomized, double-blind, placebo-controlled trials of navepegritide, including the pivotal phase 3 ApproaCH study, as well as open-label extension data of up to 3 years. Increased AGV was used as a surrogate outcome reasonably likely to predict clinical benefit.

FDA Grants Accelerated Approval to Navepegritide for Achondroplasia in Children Aged 2 Years and Older

: To treat cholestatic pruritus associated with primary biliary cholangitis

: Approval based on data from the global phase 3 GLISTEN trial, which met both primary and key secondary endpoints, demonstrating significant, rapid and sustained improvements in cholestatic pruritus and itch-related sleep interference versus placebo.

FDA Approves Linerixibat (Lynavoy) As First Treatment for Cholestatic Pruritus in PBC

: To treat moderate-to-severe plaque psoriasis in patients 12 years and older who weigh at least 40 kg and who are candidates for systemic therapy or phototherapy

: Approval based on results from 4 phase 3 trials in the ICONIC program, enrolling approximately 2500 patients aged 12 and older. The program began with ICONIC-LEAD, a multicenter, randomized, double-blind, placebo-controlled study that first established the agent's efficacy and safety profile across adults and adolescents.

Icotrokinra, an Oral Il-23 Inhibitor, Receives FDA Approval for Psoriasis

: To treat certain individuals with Hunter syndrome (Mucopolysaccharidosis type II or MPS II)

: Approval supported by data from an ongoing phase 1/2, open-label study of 47 patients with Hunter syndrome. At 24 weeks, treatment led to geometric mean reductions of –91.4% in cerebrospinal fluid (CSF) heparan sulfate and –87.9% in urinary heparan sulfate, with normalization achieved in most patients. These biomarker changes were accompanied by reductions in serum neurofilament light (NfL) chain, including –21.2% at week 49 and –70.5% at week 104, suggesting a potential effect on neuroaxonal injury.

FDA Grants Accelerated Approval to Tividenofusp Alfa for Neurologic Hunter Syndrome

: To treat platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer after one to three prior systemic treatment regimens, at least one of which included bevacizumab

: Approval supported by data from the phase 3 ROSELLA trial (NCT05257408), which enrolled patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who had received a maximum of 3 prior lines of systemic therapy, including prior bevacizumab (n = 381). In this trial, patients who received relacorilant plus nab-paclitaxel achieved a median progression-free survival (PFS) of 6.5 months (95% CI, 5.6-7.4) vs 5.5 months (95% CI, 3.9-5.9) among those who received nab-paclitaxel alone (HR, 0.70; 95% CI, 0.54-0.91; 2-sided 

FDA Approves Relacorilant Plus Nab-Paclitaxel for Platinum-Resistant Ovarian Cancer

: To improve glycemic control in adults with type 2 diabetes mellitus

: Approval based on results from the ONWARDS type 2 diabetes phase 3a program, which comprised 5 randomized, active-controlled, treat-to-target clinical trials in approximately 4000 adults with T2D evaluating insulin icodec head-to-head against standard once-daily basal insulins, including insulin glargine U100 and insulin degludec.

FDA Approves Insulin Icodec (Awiqli) as First Once-Weekly Basal Insulin for Type 2 Diabetes

Diabetes Dialogue: FDA Approves Novo Nordisk’s Insulin Icodec-abae (Awiqli) for T2D

: To reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition, in combination with a reduced-calorie diet and increased physical activity

: Approval based on findings from the ATTAIN Phase 3 global clinical development program. In ATTAIN-1, individuals taking the highest dose of orforglipron and who stayed on treatment lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo. Participants taking orforglipron, regardless of trial completion, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo. Positive topline results from ATTAIN-2 showed all 3 doses of orforglipron met the trial’s primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 weeks in adult patients with with obesity or overweight and type 2 diabetes.

FDA Approves Orforglipron (Foundayo) As First Daily GLP-1 Pill Without Food, Water Restrictions

Diabetes Dialogue: Orforglipron Receives FDA Approval for Chronic Weight Management

: To treat HIV-1 infection (as a complete regimen) in adults to replace the current antiretroviral regimen in those who are virologically-suppressed on a stable antiretroviral regimen with no history of virologic treatment failure and no known substitutions associated with resistance to doravirine

: Approval supported by findings from 2 phase 3 trials involving more than 700 adults with virologic suppression. Across both studies, the regimen met its primary end point, showing noninferior efficacy compared with both bictegravir/emtricitabine/tenofovir alafenamide and baseline antiretroviral therapies at 48 weeks.

FDA Approves Doravirine/Islatravir, a First-in-Class 2-Drug HIV Regimen

: To treat estrogen receptor-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy

: Approval backed by data from the phase 3 VERITAC-2 trial (NCT05654623), which demonstrated that patients harboring 

 mutations treated with vepdegestrant (n = 136) experienced a median progression-free survival (PFS) of 5.0 months (95% CI, 3.7-7.4) compared with 2.1 months (95% CI, 1.9-3.5) for those treated with fulvestrant (Faslodex; n = 134; HR 0.57; 95% CI, 0.42-0.77; 

 = 0.0001).1,3 The overall response rates (ORRs) in these respective groups were 19% (95% CI, 12%-27%) and 4% (95% CI, 1.6%-10%).

FDA Approves Vepdegestrant for ER+/HER2– Advanced Breast Cancer With an ESR1 Mutation

: To treat adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor

: Approval supported by data from the phase 1/2 BGB-11417-201 trial (NCT05471843), which showed that patients with relapsed/refractory MCL who were previously treated with an anti-CD20–based therapy and a BTK inhibitor (n = 103) experienced an overall response rate (ORR) of 52% (95% CI, 42%-62%) and a median time to response of 1.9 months. At a median follow-up of 11.9 months, the median duration of response was 15.8 months (95% CI, 7.4-not estimable).

FDA Approves Sonrotoclax for Relapsed/Refractory Mantle Cell Lymphoma

: To treat hypertension in combination with other antihypertensive drugs

: Approval based on results from the phase 3 BaxHTN trial, which showed mean seated systolic blood pressure fell by 15.7 mm Hg in the 2-mg group and 14.5 mm Hg in the 1-mg group, compared with 5.8 mm Hg in the placebo group. Placebo-adjusted reductions were 9.8 mm Hg (95% CI, -12.6 to -7.0; 

 <.001) for 2 mg and 8.7 mm Hg (95% CI, -11.5 to -5.8; 

FDA Approves Baxdrostat for Uncontrolled Hypertension on Background Therapy

: To treat chronic hepatitis delta virus infection in adults without cirrhosis or with compensated cirrhosis

: Approval supported by data from MYR301, a multicenter, randomized, open-label, parallel-arm phase 3 trial. At week 48, combined response was achieved in 48% of patients in the bulevirtide group compared with 2% in the delayed-treatment group.¹ The 46-percentage-point difference formed the basis for the accelerated approval, with combined response serving as the primary efficacy endpoint.

Bulevirtide Receives Historic First FDA Approval for Chronic Hepatitis Delta

Liver Lineup: HDV Diagnosis, Bulevirtide, and the Delta Pipeline

: To treat adults with blastic plasmacytoid dendritic cell neoplasm

: Approval backed by data from the phase 1/2 CADENZA trial (NCT03386513), which showed that at a median follow-up of 21.5 months, treatment-naive patients with BPDCN (n = 33) experienced a complete remission/clinical complete remission (CR/CRc) rate of 69.7% (95% CI, 51.3%-84.4%) and a median duration of CR/CRc of 9.7 months (95% CI, 2.9-not estimable [NE]).

FDA Approves Pivekimab Sunirine for Blastic Plasmacytoid Dendritic Cell Neoplasm

: To treat complicated urinary tract infections, including pyelonephritis, caused by designated susceptible microorganisms

: Approval based in part on findings from the phase 3 ENHANCE-1 trial, in which the intravenous antibiotic achieved a higher composite clinical cure and microbiologic response rate than meropenem at the test-of-cure visit.

FDA approves cefepime and zidebactam for complicated UTI

The first half of 2026 featured 22 novel FDA approvals spanning rare genetic disorders, dermatology, endocrinology/metabolism, infectious diseases, imaging, and oncology. Multiple accelerated approvals leveraged surrogate endpoints and biomarker-driven effects, while several agents addressed long-standing gaps such as chronic hepatitis delta, thyroid eye disease, and once-weekly basal insulin. Oncology approvals expanded options in ESR1-mutated ER+/HER2– metastatic breast cancer, platinum-resistant ovarian cancer, mantle cell lymphoma post-BTK inhibition, and BPDCN, reflecting continued momentum toward more targeted, evidence-based care.

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

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.

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.

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.

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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. 


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

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

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

Cardiomyopathy

6 Cardiology Headlines You Missed in June 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.

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

8 FDA Headlines You Missed in June 2026

FDA epinephrine updates, phase 3 HAE data on lonvo-z, and new food allergy prevention research from April through June 2026.

Food Allergy

Q2 2026 Recap: Allergy News & Updates 

Catch up on major trial results, groundbreaking FDA decisions, and key clinician insights from major endocrinology conferences.

Type 1 Diabetes

Type 2 Diabetes

9 Endocrinology Headlines You Missed in June 2026

June 2026 pulmonology news includes conversations with experts at the ATS and APAPP conferences, and cytisinicline's CRL.

Pulmonology

Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

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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