Diana Ernst

US FDA accepts Teva's New Drug Application (NDA) and grants Priority Review for ecopipam, a first-in-class investigational therapy for pediatric patients with Tourette syndrome.

Number of clinician-assessed flare-ups: Placebo: 66 Garetosmab 3mg/kg: 53 (RR vs placebo: 0.85 [95% CI, 0.26-2.73])

Percent change from baseline in daily cornstarch intake: -41.1% vs -10.2% (difference, -30.9% [95% CI, -40.8, -20.9]).

AstraZeneca has discontinued the phase 3 eVOLVE-Lung02 trial evaluating volrustomig — an investigational dual checkpoint inhibitor bispecific

The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for ecopipam, a selective dopamine 1 antagonist, for the treatment of pediatric patients with Tourette syndrome

Avulux granted FDA De Novo authorization, creating the first lens classification for migraine-associated light sensitivity. News release. Avulux. August 24, 2026.

ADARx Pharmaceuticals receives FDA Fast Track designation for onvuzosiran for the treatment of HAE. News release. ADARx Pharmaceuticals. August 24, 2026.

The Food and Drug Administration (FDA) has approved Ziihera ® (zanidatamab-hrii) for the first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive advanced gastroesophageal adenocarcinoma (GEA).

US Food and Drug Administration. FDA approves drug to treat HIV infection in newborns. August 25, 2026.

Median OS: 13.2 months vs 6.6 months (hazard ratio [HR], 0.40 [95% CI, 0.30-0.54]; P Median PFS: 7.3 months vs 3.5 months (HR, 0.45 [95% CI, 0.34-0.59]; P