The past year saw significant progress in allergy and immunology, with multiple US Food & Drug Administration (FDA) approvals expanding treatment options for hereditary angioedema (HAE), including donidalorsen, sebetralstat, and garadacimab-gxii. Clinicians now have access to therapies that improve attack prevention, offer oral and less frequent dosing options, and provide new tools for pediatric patients, addressing long-standing gaps in care.

Beyond HAE, advances in food allergy management, chronic rhinosinusitis, and anaphylaxis treatment highlighted the evolving landscape. Early peanut introduction continues to reduce allergy prevalence, intranasal epinephrine offers a needle-free emergency option, and dupilumab shows promise in difficult-to-treat allergic fungal rhinosinusitis. Together, these developments are reshaping clinical practice and patient management across age groups.

FDA News

FDA Approves Donidalorsen to Prevent Hereditary Angioedema Attacks

The FDA approved the RNA-targeted donidalorsen (DAWNZERA) to prevent HAE attacks in patients aged ≥ 12 years, announced by Ionis Pharmaceuticals on August 21, 2025. Backed by OASIS-HAE, OASISplus, and phase 2 OLE trials, the therapy cut monthly attacks up to 81%, with sustained safety.

Related: FDA’s Approval of Donidalorsen for HAE, With William Lumry, MD

Sebetralstat FDA-Approved as First Oral, On-Demand for Hereditary Angioedema

Announced on July 7, 2025, the FDA approved KalVista Pharmaceuticals’ sebetralstat (Ekterly), the first oral, on-demand therapy for acute HAE in patients aged ≥ 12 years. Supported by phase 3 KONFIDENT trials, experts say it enables earlier, guideline-aligned treatment.

FDA Approves Factor XIIa-Targeting Garadacimab-gxii (ANDEMBRY) for HAE Attacks

CSL announced on June 16, 2025, that the FDA approved garadacimab-gxii (ANDEMBRY), the first factor XIIa–targeting therapy to prevent HAE attacks in patients aged ≥ 12 years. CSL’s once-monthly monoclonal antibody reduced HAE attacks by ≥ 99% versus placebo in the phase 3 VANGUARD trial, offering a convenient, citrate-free prophylactic option.

FDA Approves First Interchangeable Biosimilar for Omalizumab

Announced on March 9, 2025, the FDA approved omalizumab-igec (OMLYCLO), the first interchangeable biosimilar to Xolair, for asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy, and chronic spontaneous urticaria. Phase 3 trials confirmed bioequivalence, safety, and efficacy. Celltrion USA highlights OMLYCLO’s potential to expand patient access, reduce healthcare costs, and offer convenient prefilled syringe dosing.

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

Biocryst on December 12, 2025, announced that the FDA approved berotralstat (ORLADEYO) oral granules for children aged 2–11 years with HAE, providing the first pediatric oral prophylactic option. Based on APeX-P trial data, berotralstat safely reduced monthly attacks, offering a less burdensome alternative to infusions or injections and addressing a critical treatment gap in young patients with HAE.

Trial Updates and New Guidelines

Cephalexin Recommended for Dermatologic Surgery with Penicillin Allergy

The American Society for Dermatologic Surgery recommends cephalexin as the first-line prophylactic antibiotic for patients with penicillin allergy undergoing dermatologic surgery. With low cross-reactivity, especially among first-generation cephalosporins, cephalexin offers superior safety and efficacy. True penicillin allergy is uncommon, and most patients lose sensitivity over time.

New Guidelines Outline When to Consider Sinus Surgery for Chronic Rhinosinusitis

The American Academy of Otolaryngology–Head and Neck Surgery released updated guidelines for chronic rhinosinusitis, offering 11 evidence-based recommendations. Surgery is advised when benefits outweigh medical therapy, particularly for patients with polyps, fungal infections, frequent exacerbations, or worsening asthma, emphasizing diagnosis confirmation and avoiding unnecessary antibiotics.

Over 70% of Toddlers Tolerate 3 to 4 Peanut Kernels 3 Years After Peanut Patch

New data from the 2025 ACAAI meeting show the Viaskin Peanut Patch builds peanut tolerance in over 70% of toddlers after 3 years. Epicutaneous immunotherapy safely delivers peanut protein through the skin, increasing tolerated amounts and reducing severe reactions. This patch offers a promising long-term option for early peanut allergy management.

Dupilumab Shows Promise for Allergic Fungal Rhinosinusitis in Phase 3 Trial, With Amber Luong, MD, PhD

Phase 3 LIBERTY AIMS data show dupilumab (Dupixent) significantly improves outcomes in allergic fungal rhinosinusitis (AFRS), a challenging CRSwNP subtype. In 62 patients, dupilumab reduced sinus opacification, nasal polyp size, congestion, and the need for surgery or oral corticosteroids, offering a safe, steroid-sparing treatment option for difficult-to-treat AFRS.

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

Phase 3 RAPIDe-3 trial shows oral deucrictibant rapidly relieves HAE symptoms, with onset under 90 minutes and most attacks resolving with a single dose. The bradykinin B2 receptor antagonist demonstrated significant symptom improvement versus placebo and a favorable safety profile, supporting its potential as an on-demand HAE therapy.

Feature Content

Peanut Allergy Rates Plummet 10 Years After AAP Early Introduction Guidelines

A decade after AAP's early peanut introduction guidelines, peanut allergy rates dropped 27–43%, with overall IgE-mediated food allergies also declining. This report highlighted the real-world impact of early introduction while emphasizing ongoing challenges in guideline implementation.

One Year Later: How Intranasal Epinephrine Is Changing Emergency Allergy Treatment

One year after FDA approval, intranasal epinephrine (neffy) offers a needle-free, easy-to-use alternative for anaphylaxis, improving accessibility, clinician experience, and patient adherence, particularly for children and needle-averse individuals.

Microbes, Medicine, Modern Life May Drive Food Allergy Rise, Experts Say

Experts attribute rising food allergies to delayed allergen introduction, microbial imbalances, antibiotic use, C-sections, and environmental factors. Early exposure and microbiome-focused strategies may help curb this growing public health concern.

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

In 2025, the FDA approved 3 new HAE treatments—garadacimab-gxii, sebetralstat, and donidalorsen—expanding personalized care, improving attack prevention, and highlighting the ongoing need for pediatric-focused therapies.