ViiV Healthcare Cabenuva Meets Primary Endpoint in Phase IIIb CROWN Study of People With HIV Viremia

GSK - GlaxoSmithKline

ViiV Healthcare Cabenuva (cabotegravir + rilpivirine) met the primary endpoint of the phase IIIb CROWN study, with superior six-month viral suppression versus standard oral ART in people with detectable HIV. The use is investigational and not approved.

GSK Ris-Rez SCLC Data: Phase III Trial Cuts Risk of Death by 54% Versus Topotecan

GSK - GlaxoSmithKline

GSK’s B7-H3-targeted ADC Ris-Rez cut the risk of death by 54% versus topotecan in the Phase III ARTEMIS-008 trial in relapsed small cell lung cancer in China, with a median overall survival of 18.5 months and fewer severe side effects than chemotherapy.

GSK and Spero Therapeutics Secure Historic Utebzi FDA Approval for Adults with Complicated Urinary Tract Infections

GSK - GlaxoSmithKline

The historic Utebzi FDA approval introduces the first and only oral carbapenem antibiotic for adult patients suffering from complicated urinary tract infections (cUTIs), offering an effective outpatient treatment pathway to combat multidrug-resistant pathogens.

GSK Secures Japan Orphan Drug Designation for Risvutatug Rezetecan in Small-Cell Lung Cancer

GSK - GlaxoSmithKline

GSK’s risvutatug rezetecan has officially secured Orphan Drug Designation from Japan’s MHLW for the treatment of small-cell lung cancer (SCLC). Supported by durable response data from the ARTEMIS-001 trial, this B7-H3-targeted antibody-drug conjugate aims to transform the prognosis for patients with extensive-stage disease, who currently face a median survival of just 8 months. This marks the sixth major global regulatory designation for risvutatug rezetecan, signaling its critical role in the future of oncology.