Chelsie Derman

The FDA granted DT120 (lysergide) ODT Breakthrough Therapy designation for MDD, citing promising phase 3 Emerge data.

The FDA granted lonvo-z priority review for HAE, setting a PDUFA date of March 10, 2027 based on positive Phase 3 HAELO data.

New approval for tirzepatide, phase 3 wins for avexitide and retatrutide, and a GLP-1 telehealth safety gap in August's biggest endocrinology stories.

A regulatory resubmission, 2 phase 3 psychedelic trial readouts, new TMS dosing data, and an MDD genetics study, all in this August 2026 recap.

FDA actions, a WAO consensus update, and late-stage trial data in food allergy, anaphylaxis, CRSwNP, and EoE, all in this August 2026 recap.

The Phase 3 CROSSING trial showed tezepelumab improved histologic remission and dysphagia symptoms through week 52 in eosinophilic esophagitis.

Pamufetinib 50 mg and 100 mg did not slow FVC decline versus continued nintedanib or pirfenidone in progressive fibrosing ILD, a phase 2b trial found.

Deupirfenidone 825 mg reduced 26-week FVC decline by 91.0 mL versus placebo in the phase 2b ELEVATE-IPF trial in idiopathic pulmonary fibrosis.

The generic nasal spray is bioequivalent to Haleon's Flonase, indicated for nasal symptoms of allergic rhinitis.

A randomized TMS trial found lower DLPFC electric-field strength, not higher intensity, correlated with greater depression improvement.

The first-in-class D1 receptor antagonist earns Priority Review and Orphan Drug designation, with an FDA action date late in Q1 2027.

A biomarker study links immune signaling (IL-7/IL-15) and brain gamma-wave activity to ketamine response in TRD.

An international 35-expert Delphi panel reached consensus on 33 of 35 statements on precautionary allergen labelling reference doses.

A FORWARD cohort study of 1,359 children found race, income, health literacy, and neighborhood deprivation each predicted food allergy resolution.

DT120 ODT produced a 5.4-point placebo-adjusted HAM-A reduction at week 12 in the phase 3 Voyage trial for generalized anxiety disorder.

Resilient Pharmaceuticals has resubmitted its MDMA-assisted therapy NDA for PTSD without a new phase 3 trial, MAPS reported.

Aquestive Therapeutics reported human factors and pharmacokinetic data supporting a planned third-quarter 2026 resubmission of the Anaphylm NDA for Type 1 allergic reactions.

A prospective cohort study found 94% of patients tolerated direct initiation at maintenance OIT dosing after brief omalizumab pretreatment.

In RESOLVE-Lung, the anti-GM-CSF antibody namilumab did not reduce rescue events or improve lung function versus placebo in chronic pulmonary sarcoidosis.

The mRNA-based vaccine wins full approval for adults aged 50 to 64 years and accelerated approval for adults aged ≥ 65 years following unanimous VRBPAC backing.

FDA approval is based on phase 3 FirstLight and RadiantLight trials, the first therapy to directly restore orexin signaling in adults with NT1.

Oral encapsulated FMT increased peanut reactivity thresholds in 6 of 15 adults, tied to RORγt+ Treg cell expansion.

Centanafadine FDA approval, DT120 EMERGE trial results, and COMP360 psilocybin data headline this month's psychiatry coverage.

The FDA has granted Fast Track designation to PVX108, Aravax's investigational peptide immunotherapy for peanut allergy, ahead of phase 2 data expected later in 2026.

FDA expands Ryaltris to younger children with seasonal allergic rhinitis, Palforzia discontinues, and HAE's oral pipeline widens with deucrictibant and sebetralstat.

Moderator Greg Bensch and a panel of allergists discuss itch control, access barriers, and guideline gaps shaping newer AD topicals in this clinical forum.

In the OUTMATCH stage 2 randomized trial, omalizumab achieved greater intention-to-treat success than multiallergen oral immunotherapy.

The first-in-class NDSRI showed significant symptom improvement as early as week 1 across 4 phase 3 trials but carries boxed warnings for suicidality and abuse potential.

Allergists explain what's settled about epinephrine nasal spray, what's not, and how to counsel patients before anaphylaxis guidelines catch up.

FDA expands RYALTRIS® approval to children aged 6 to 11 with seasonal allergic rhinitis, based on phase 3 trial data.