Chelsie Derman

Aquestive has resubmitted its needle-free epinephrine film after an FDA rejection over usability, not efficacy. This FAQ covers what changed.

What lonvo-z is, how it works, and what a Priority Review designation means for the HAE gene-editing therapy.

The resubmission follows an FDA Complete Response Letter and cites human factors data showing pouch-opening time fell from 17 to 3 seconds.

New research links wildfire smoke to lasting respiratory decline and skin flares, months after exposure ends.

As ragweed and mold drive this year's fall symptom surge, updated GRADE recommendations shift first-line therapy toward combination intranasal treatment.

Deucrictibant XR reduced HAE attack rates by 83% versus placebo in the pivotal phase 3 CHAPTER-3 study across all 3 HAE types.

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.