5 Allergy Headlines You Missed in December 2025

December 2025 capped a transformative year in allergy and immunology, with late-breaking regulatory decisions, pivotal trial results, and emerging clinical insights reinforcing the rapid pace of change across the field. This month in review highlights key developments shaping day-to-day practice, including new and forthcoming therapies for hereditary angioedema (HAE), advances in food allergy management, and data that further refine treatment selection and patient counseling.

For clinicians, December’s updates underscore a broader shift toward more personalized, less burdensome care, particularly for pediatric and multi-allergic populations, while setting the stage for continued innovation heading into 2026.

FDA Approved Another HAE Treatment on December 12th

FDA Approves Oral Berotralstat for Children Aged 2 – 11 Years with HAE

The US Food and Drug Administration (FDA) has approved berotralstat (ORLADEYO) oral granules for children aged 2 to 11 years with HAE, marking the first FDA-approved oral prophylactic therapy designed for this pediatric population. Announced by BioCryst Pharmaceuticals, the approval addresses a longstanding treatment gap for children under 12. The decision was supported by positive interim data from the APeX-P trial, demonstrating sustained reductions in HAE attack rates and a safety profile consistent with adults. Experts from institutions, including UCLA, highlighted the reduced treatment burden compared with injectable therapies, expanding long-term management options for pediatric HAE.

Promising Phase 3 HAE Results

Pharvaris’ Deucrictibant Provides Rapid Relief for HAE in Phase 3 RAPIDe-3 Trial

Pharvaris’ oral bradykinin B2 receptor antagonist deucrictibant met its primary endpoint in the phase 3 RAPIDe-3 trial, providing rapid relief of HAE attacks in under 90 minutes. In the global, placebo-controlled study of 134 patients aged ≥ 12 years, deucrictibant significantly shortened time to symptom onset, substantial relief, and complete resolution versus placebo. Most attacks were controlled with a single 20-mg dose, and > 93% required no rescue medication. The therapy was well tolerated, with no treatment-related serious adverse events. Pharvaris plans to submit a New Drug Application (NDA) to the FDA in 2026.

Allergy Field Spotlights from Our This Year in Medicine Series

A New Era in Food Allergy Treatment: The Push Toward Multi-Allergen Immunotherapy

Food allergy care is entering a new phase as clinicians push toward therapies that address multiple allergens simultaneously. Following the FDA approval of omalizumab (Xolair) in 2024, experts report meaningful quality-of-life improvements for patients with multiple food allergies by increasing reaction thresholds, though it is not curative.

With food allergy prevalence up 50% since the 1990s, 2025 research highlighted renewed interest in multi-allergen oral immunotherapy (OIT), including investigational ADP101, and growing momentum for sublingual immunotherapy. Despite mixed trial results, clinicians see promise in raising thresholds across several foods. With evolving prevention strategies and new devices, these advances signal a shifting landscape in food allergy management.

Rare Disease, Rapid Progress: FDA's HAE Approvals in 2025 Signal Changing Course

Before berotralstat, the FDA approved 3 other new HAE therapies—garadacimab-gxii (Andembry), sebetralstat (Ekterly), and donidalorsen (Dawnzera)—marking a major expansion in treatment options for this rare genetic disease. Experts from UCLA Health and the University of Colorado highlighted how these approvals enable more personalized care through novel mechanisms, oral and injectable options, and less frequent dosing.

Despite this rapid progress, clinicians emphasized persistent unmet needs, particularly for pediatric patients under 12 years and for therapies that improve portability and access. Overall, the 2025 approvals signal a turning point in HAE management and research momentum.

2025 Year in Review

​​Allergy in 2025: Year in Review

As 2025 came to an end, we put together a year-in-review that reflects the most impactful developments that shaped allergy and immunology over the past 12 months. From landmark FDA approvals to pivotal trial readouts and evolving clinical guidance, 2025 marked a period of accelerated progress across both rare and common allergic diseases.

Breakthroughs in HAE expanded preventive and on-demand options, while advances in food allergy prevention, immunotherapy, and anaphylaxis management influenced everyday clinical practice. These highlights capture a year defined by therapeutic innovation, growing personalization of care, and meaningful shifts in how clinicians approach allergy management across the lifespan.