Anaphylaxis

FDA clears pediatric HAE oral therapy as intranasal epinephrine and heat-treated peanut/egg OIT studies point to safer allergy care.

Despite usability concerns cited by the FDA, investigators say dibutepinephrine’s needle-free, portable design could still address gaps in real-world epinephrine use.

The CRL cited deficiencies limited to packaging and administration, with resubmission expected as early as Q3 2026.

As the January 31 PDUFA date approaches, Golden discusses that epinephrine sublingual film may deliver symptom relief as rapidly as autoinjectors, with added portability.

Proteomic fragmentation may explain reduced allergenicity and point to a safer substrate for peanut oral immunotherapy compared with current options, new data suggests.

New data show heat- and pressure-treated peanuts significantly reduce IgE binding, skin test reactivity, and oral challenge severity in allergic patients.

Interim phase 2 results show NS002 delivered faster absorption and greater early epinephrine exposure than EpiPen, with comparable safety and tolerability.

Analysis of > 9,000 FDA reports highlights previously unrecognized adverse events, including myocardial stunning, nerve damage, and real-world drug ineffectiveness.

An 18-month study of children with up to 5 nut allergies found that a 30-mg per-nut maintenance dose significantly improved tolerated doses without serious adverse events.

A study found tahini was associated with lower reaction thresholds and higher anaphylaxis rates than whole seeds, suggesting it may better reflect true sesame allergy risk.

Q4 2025 brought key FDA approvals and phase 3 advances in HAE, peanut allergy, multi-allergen immunotherapy, and allergic fungal rhinosinusitis.

December highlights: FDA approval of berotralstat for pediatric HAE, phase 3 RAPIDe-3 results, and allergy field spotlights in our This Year in Medicine series.

Significant advancements in allergy treatments emerge in 2025, including 4 FDA approved treatments for hereditary angioedema.

A quick guide for clinicians on epinephrine dosing, optimal observation periods, and the role of tryptase and other labs in anaphylaxis care.

At ACAAI 2025, Shaker dispels epinephrine myths, emphasizing that it is safe, effective, and underused in anaphylaxis care.

At ACAAI 2025, Shaker highlighted evolving therapies and real-world barriers that continue to limit optimal anaphylaxis management.

A preview of 5 slated expert interviews and 5 late-breaking clinical trials to watch out for at ACAAI 2025.

Investigators estimate that replacing individually prescribed school-based devices with spare adrenaline autoinjectors could improve access for students.

Adults given an initial 0.5 mg intramuscular epinephrine dose were less likely to need further intervention than those receiving 0.3 mg, a study found.

A new study found that adjunct omalizumab helped most patients safely continue honeybee venom immunotherapy after prior severe allergic reactions.

A new trial reveals that educational interventions significantly enhance pediatricians' adherence to guidelines for early peanut introduction.

Explore the latest advancements in allergy and immunology, including new therapies, FDA approvals, and innovative clinical strategies for improved patient care from Q3.

This month in review features the latest breakthroughs in allergy treatments, including innovative therapies for cat and peanut allergies.

Research suggests emergency department–discharged children rarely return within 7 days, questioning routine corticosteroid use for mild-to-moderate reactions.

Real-world data show epinephrine nasal spray achieved an 89.2% success rate in treating anaphylaxis, nearly identical to the injection’s response rate.