Seoul, South Korea – The European Medicines Agency (EMA) has granted orphan drug designation to YH35995, Yuhan Corporation’s investigational oral therapy for Gaucher disease. The decision follows a similar orphan drug designation from the U.S. Food and Drug Administration (FDA) in April, reinforcing the therapy’s potential as a treatment for...

Gothenburg, Sweden – Cereno Scientific (Nasdaq First North: CRNO B), a biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today reported further analyses from the 12-month Expanded Access Program (EAP) with its lead drug candidate CS1 in pulmonary arterial hypertension (PAH). Over...

PRINCETON, N.J. & TOKYO, Japan — Otsuka Pharmaceutical Development & Commercialization, Inc. and Otsuka Pharmaceutical Co., Ltd. (Otsuka) today announced positive topline full study results from the Phase 3 VISIONARY trial. VOYXACT® (sibeprenlimab-szsi) demonstrated statistically significant stabilization of kidney function, with evidence of improvement over two years, as assessed by annualized...