Medscape

FDA Questions Value of Single-Arm Studies for Cancer Approvals

The US Food and Drug Administration’s (FDA’s) approval decision about a new treatment for non–muscle invasive bladder cancer (NMIBC) hinges on whether a single-armed trial can be trusted to adequately ...
Nasdaq

Dupixent® (dupilumab) Data at Revolutionizing Atopic Dermatitis (RAD) Conference Reinforce Use in Atopic Dermatitis Patients with Skin of Color

TARRYTOWN, N.Y. and PARIS, June 07, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today presented results from the DISCOVER Phase 4, single-arm, open-label trial ...
Nasdaq

Merit Medical Releases 12-Month Efficacy Results for the Single-Arm Arteriovenous Graft (AVG) Cohort of the WRAPSODY® Arteriovenous Efficacy (WAVE) Trial

In the AVG cohort of the US pivotal trial, the Merit WRAPSODY Cell-Impermeable Endoprosthesis (CIE) achieved 60.2% target lesion primary patency (TLPP) at 12 months. SOUTH JORDAN, Utah, May 05, 2025 ...