Policy & Regulation
United Therapeutics wins FDA acceptance for ralinepag PAH filing
24 August 2026 - Biotechnology company United Therapeutics Corporation (Nasdaq:UTHR) said on Monday that the US Food and Drug Administration (FDA) has accepted its New Drug Application for ralinepag t...
Takeda wins Japan approval for ORZEYFUL to treat underlying cause of narcolepsy type 1
24 August 2026 - Japanese pharmaceutical company Takeda (TSE:4502) (NYSE:TAK) announced on Monday that Japan's Ministry of Health, Labour and Welfare has approved ORZEYFUL (oveporexton) for adult...
Acadia wins EU approval for DAYBU as first treatment for Rett syndrome
24 August 2026 - Acadia Pharmaceuticals Inc (Nasdaq:ACAD), a developer of treatments for neurological and rare diseases, announced on Monday that the European Commission has granted marketing authoris...
Gilead expands Trodelvy role in first-line metastatic triple-negative breast cancer in Europe
24 August 2026 - Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Monday that the European Commission has approved Trodelvy (sacituzumab govitecan-hziy) with Keytruda (pembroli...
GSK's Jemperli wins FDA priority review for advanced rectal cancer
24 August 2026 - Biopharmaceutical company GSK plc (LON:GSK) (NYSE:GSK) announced on Monday that the US Food and Drug Administration (FDA) has accepted for priority review its supplemental Biologics L...
GSK secures first global approval for Hibsago in Japan
24 August 2026 - Biopharmaceutical company GSK plc (LSE: GSK) (NYSE: GSK) disclosed on Monday that it has received Japan's first global approval for Hibsago (bepirovirsen) as a functional cure fo...