7 Allergy Headlines You Missed in August 2026

August delivered a wave of allergy and immunology news, from US Food & Drug Administration (FDA) actions on peanut allergy and allergic rhinitis to a new international consensus on allergen labeling. Late-stage trial data also emerged for anaphylaxis, eosinophilic esophagitis (EoE), and chronic rhinosinusitis with nasal polyps (CRSwNP) therapies.

Below is a roundup of the 7 top allergy and immunology headlines from August 2026. Each entry links to HCPLive's full coverage for further clinical detail.

FDA Approvals and Designations in Allergy Care

Aravax's PVX108 Receives FDA Fast Track Designation for Peanut Allergy

The FDA granted Fast Track designation to PVX108, Aravax's investigational peptide immunotherapy for peanut allergy, on August 3, 2026. PVX108 uses 7 short synthetic peanut allergen fragments delivered intradermally once monthly without dose escalation, distinguishing it from oral immunotherapy options such as Palforzia, which was discontinued in July 2026. Aravax expects topline data from its ongoing international phase 2 trial later this year.

WAO Delphi Consensus Endorses ED05-Based Allergen Labelling

A World Allergy Organization Delphi panel reached consensus on ED05-based allergen labeling, recommending that precautionary "may contain" warnings rely on population-adjusted eliciting dose (ED05) reference doses rather than fixed allergen concentrations. The 35-expert, 3-round e-Delphi reached agreement on 33 of 35 statements, rejecting a fixed 5 ppm cutoff in favor of quantitative, allergen-specific risk assessment.

FDA Approves Glenmark’s Generic Fluticasone Propionate Nasal Spray

The FDA approved Glenmark's generic fluticasone propionate nasal spray, a bioequivalent version of Haleon's Flonase indicated for nasal symptoms of allergic rhinitis. The approval came through the bioequivalence pathway, so no independent efficacy or safety program accompanied the clearance. Glenmark did not disclose pricing or launch timing.

Late-Stage Trial Data in Allergy and Immunology

Tezepelumab Meets Co-Primary Endpoints in Phase 3 EoE Trial

Tezepelumab (Tezspire) met both co-primary endpoints in the phase 3 CROSSING trial in eosinophilic esophagitis (EoE), with histologic remission and dysphagia symptom improvements sustained through week 52 across both doses tested. The 368-patient trial marks the third epithelial-driven inflammatory disease, after severe asthma and chronic rhinosinusitis with nasal polyps, in which the TSLP-targeting antibody has shown clinically meaningful efficacy. AstraZeneca and Amgen plan to present full secondary endpoint and safety data at an upcoming medical meeting.

Related: Tezepelumab's TSLP Blockade May Address Refractory EoE Gap I Interview with Arjan Bredenoord, MD

Dibutepinephrine (Anaphylm) Meets Pharmacokinetic Goals in Anaphylaxis

Aquestive Therapeutics reported positive human factors and pharmacokinetic data for dibutepinephrine (Anaphylm) sublingual film, supporting a planned third-quarter 2026 resubmission of its New Drug Application. Revised packaging cut median pouch-opening time from 17 to 3 seconds after an earlier FDA Complete Response Letter cited use errors, and a follow-up pharmacokinetic study found no administration errors in the self-administration arm.

Phase 2 CRSwNP Trial Meets Primary Endpoint

BEL512 Improves CRSwNP and Symptoms in Phase 2 Trial

BEL512, Belenos Biosciences' bispecific antibody targeting TSLP and IL-13, met its primary endpoint and all secondary endpoints in a phase 2 trial in chronic rhinosinusitis with nasal polyps (CRSwNP). Statistically significant reductions in Nasal Polyp Score at week 24 were observed across all dosing arms, alongside improvements in congestion, smell, and quality-of-life measures. Keymed Biosciences plans a phase 3 trial in China, while Belenos plans a phase 3 trial outside China in the first half of 2027.

Long-term Benefit of Peanut OIT

Early-Life Peanut OIT’s Decade-Long Benefit, With Jennifer Dantzer, MD

IMPACT-PLuS, a decade-long follow-up of the Immune Tolerance Network's IMPACT trial, found 80% of children treated with early-life peanut oral immunotherapy (OIT) remained peanut tolerant a median of 9 years later, according to Jennifer A. Dantzer, MD, MHS, of Johns Hopkins University School of Medicine. All 15 participants who achieved remission in the original trial were still eating peanut at follow-up, though 35% of the pnOIT-only group reported an allergic reaction since the original trial ended.