Browsing: approved

Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted marketing authorization to Imcivree (setmelanotide) for acquired hypothalamic obesity (HO), making it the first approved therapy for this indication in Japan. Boston-based Rhythm Pharmaceuticals (Nasdaq: RYTM) holds the rights directly and said it expects a commercial launch before the end of 2026, pending final pricing…

According to a new announcement, the FDA has granted accelerated approval to pariglasgene brecaparvovec-opnr (Genglycos; Ultragenyx Pharmaceutical, Inc), a one-time, liver-directed AAV8 gene therapy, to reduce daily cornstarch intake as an adjunct to nutritional management in patients 8 years and older with glycogen storage disease type Ia (GSD1a).1 The approval, announced August 19, 2026, makes…