Q1 2026 Recap: Allergy News and Updates

The first quarter of 2026 delivered a series of regulatory milestones, guideline updates, and late-phase clinical data that reshaped key areas across allergy and immunology. US Food & Drug Administration (FDA) approvals expanded treatment options for pediatric hereditary angioedema (HAE) and allergic fungal rhinosinusitis. Label changes also expanded treatment options for anaphylaxis in children under 4 years old.

At the same time, new international guidance sought to standardize epinephrine use and prioritize rapid access to on-demand HAE therapies. Pipeline progress, including phase 3 food allergy immunotherapy, reflected continued movement toward precision-driven care. This review spotlights 9 allergy headlines in Q1 of 2026.

Major FDA Decisions in Allergy

FDA Approves Dupilumab for AFRS in Patients Aged ≥ 6 Years with Prior Surgery

The FDA approved dupilumab (Dupixent) for allergic fungal rhinosinusitis (AFRS) in adults and pediatric patients aged ≥ 6 years with prior sinonasal surgery, marking the first therapy specifically indicated for the condition. The decision addressed a disease characterized by type 2 inflammation and high postsurgical recurrence rates.

Clinical trial data demonstrated reductions in signs and symptoms, with improvements in nasal congestion, polyp burden, and need for corticosteroids or repeat surgery, supporting the biologic’s role in disease modification.

FDA Approves Oral Berotralstat for Pediatric HAE, With Jolanta Bernatoniene, PhD

The FDA approved BioCryst’s oral berotralstat (ORLADEYO) for long-term prophylaxis of HAE in children aged 2–11 years, becoming the first once-daily oral preventive option in this population.

Prior pediatric prophylaxis relied on injectable therapies, which were associated with caregiver burden and adherence challenges. Investigators highlighted that the oral formulation may reduce treatment barriers and improve the quality of life for pediatric patients and families.

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

The FDA removed the minimum age requirement for epinephrine nasal spray (neffy), shifting to weight-based eligibility alone. This labeling change expanded access to needle-free epinephrine for younger children at risk for anaphylaxis. The update also included real-world usability considerations such as storage flexibility and administration guidance.

FDA Issues CRL to Dibutepinephrine (Anaphylm) Sublingual Film for Type 1 Allergic Reactions

The FDA issued a complete response letter for dibutepinephrine (Anaphylm) sublingual film for type I allergic reactions. The agency cited deficiencies in human factors validation, including difficulty opening packaging and improper placement, which raised safety concerns during anaphylaxis treatment.

New HAE & Anaphylaxis Recommendations

Pediatric HAE Guideline Recommends Sebetralstat as First-Line Therapy

A new international pediatric HAE guideline recommended oral sebetralstat as a first-line acute treatment option for adolescents aged ≥12 years. The guidance emphasized early administration and availability of on-demand therapy to reduce attack severity and duration.

Recommendations also stressed maintaining access to treatment for ≥ 2 attacks and ensuring education for patients and caregivers to support timely intervention.

Related: Updated Anaphylaxis Guidelines, Early Management Priorities

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

An international expert panel led by Timothy E. Dribin, MD, from Cincinnati Children’s Hospital Medical Center, released consensus-based recommendations to reduce variation in epinephrine use during allergic reactions. The guidance emphasized epinephrine for multi-organ involvement or severe respiratory or cardiovascular symptoms, while acknowledging uncertainty in moderate isolated cutaneous presentations.Experts noted persistent underuse of epinephrine, with real-world data showing only a minority of patients receive it prior to emergency department arrival, underscoring the need for clearer action plans.

Accepted NDA

FDA Accepts NDA for Bezuclastinib in Non-Advanced Systemic Mastocytosis

The FDA accepted a new drug application (NDA) for Cogent Biosciences’ bezuclastinib in non-advanced systemic mastocytosis, supported by clinical trial data evaluating symptom improvement and disease burden reduction. The FDA assigned a PDUFA target action date of December 30, 2026.

Fast Track Designation for siRNA Therapy

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

The FDA granted Fast Track designation to Argo Biopharmaceutical’s BW-20805, an investigational siRNA therapy targeting the kallikrein pathway for HAE prophylaxis. The designation reflects potential for sustained disease suppression and long-acting prevention strategies.

Late-Stage Peanut Patch Data

VIASKIN Peanut Patch Shows Strong Phase 3 VITESSE Results, With David Fleischer, MD

Phase 3 VITESSE trial data demonstrated strong desensitization outcomes with the VIASKIN peanut patch, an epicutaneous immunotherapy, in peanut-allergic children. The study showed that 82.8% of children receiving the peanut patch vs 48% receiving placebo increased their eliciting dose over 12 months.