Victoria Johnson

There was a 79% relative reduction in annualized asthma exacerbation rate in the 6 months after starting treatment compared with the prior 6 months.

Sabato discussed how research in the field will inform how to best utilize novel therapies for indolent systemic mastocytosis now that a disease-modifying therapy is available.

Alexis discussed the latest research in the field and new management strategies for children with atopic dermatitis.

This FDA News Month in Review provides a round-up of regulatory decisions from February 2025.

Chovatiya discussed his talk at the 2025 AAAAI/WAO Joint Congress.

Fidanacogene elaparvovec was approved under the name Beqvez in April 2024.

Dupilumab improved R5–R20 and AX compared to placebo, possibly explaining improvements in disease control.

Mukkamala also discussed the importance of expanding non-opioid pain relief options.

Participants in a phase 3 OLE had a mean monthly attack rate of 0.08.

Sebetralstat has a PDUFA date of June 12, 2025, for treating HAE in patients 12 years and older.

Afif El-Hasan, MD of Kaiser Permanente in California joins host Albert Rizzo, MD, to discuss the acute effects of wildfire smoke on air quality.

Three subgroup analyses of the phase 3 NAVIGATOR study are set to be presented at the AAAAI/WAO Joint Congress.

Alvotech and Teva announced that the biosimilar will be interchangeable with the reference after ustekinumab-auub’s exclusivity expires in April 2025.

In new data to be presented at AAAAI, the therapy was well-tolerated in people as young as 2 years old.

By week 52, remibrutinib and placebo-to-remibrutinib groups had similar levels of urticaria control.

Chalmers discussed how brensocatib’s potential approval may transform the currently empty treatment landscape for bronchiectasis.

Pitolisant was evaluated for the supplemental indication in the phase 3 INTUNE study, which did not meet its primary outcome of reducing excessive daytime sleepiness.

Data from 3 pooled phase 3 studies in children, adolescents, and adults will be presented at the AAAI/WAO Joint Congress.

Alvotech and Teva expect the review to be completed in the fourth quarter of 2025.

At week 12, a higher proportion of participants on rilzabrutinib 1200mg a day (60.9%) achieved AAS7 scores of 0 than placebo-treated participants (30.8%).

Targeted Genomics’ GHR test uses NGS to detect genetic variants in genomic DNA isolated from at-home collected saliva samples.

At 6 months, baseline monthly rates of 0.45 for mild, 1.54 for moderate, and 0.14 for severe attacks were reduced to 0.10, 0.08, and 0.00, respectively.

Bernstein discussed recent and upcoming research and management of angioedema in patients with urticaria.

Around half of participants had insufficient vitamin D levels.

Fifteen of 16 patients with chronic ulcers in a small study had positive patch test to common wound care products.

These findings were from a 52-week analysis of a Phase-2 trial in participants with chronic spontaneous urticaria.

Avapritinib 25mg daily significantly improved quality of life (QoL), disease control, and basal serum tryptase (BST) levels.

Boehringer plans to soon submit a new drug application for nerandomilast for treating PPF to the FDA.

Emblaveo combines aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor.

Approved under the name Dupixent in September 2024, the biologic is the first of its kind approved for COPD.