Policy & Regulation
Dicot Pharma submits FDA application for LIB-01 phase 2b study
25 May 2026 - Dicot Pharma AB (Nasdaq First North:DICOT) announced on Monday that it has submitted an Investigational New Drug application to the US Food and Drug Administration (FDA) in preparation f...
European Commission approves Pharming's Joenja for APDS treatment in the EU
25 May 2026 - Biopharmaceutical company Pharming Group N.V. (Euronext Amsterdam:PHARM) (NASDAQ:PHAR) announced on Friday that the European Commission has granted marketing authorisation for Joenja (le...
Caliway Biopharmaceuticals receives US FDA IND clearance for second global Phase 3 study of CBL-514
25 May 2026 - Caliway Biopharmaceuticals (TWSE:6919), a Taiwan-based clinical-stage biopharmaceutical company, announced on Friday that it has received approval from the US Food and Drug Administratio...
AbbVie's MAVIRET receives positive opinion from European regulator
25 May 2026 - US biopharmaceutical company AbbVie (NYSE:ABBV) announced on Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive...
Enhertu recommended for EU approval in previously treated HER2 positive metastatic solid tumours
22 May 2026 - Japanese healthcare company Daiichi Sankyo Co Ltd (TYO:4568) announced on Friday that Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union as a monoth...
OSE Immunotherapeutics reports positive Phase 2 ovarian cancer trial results
22 May 2026 - French biotechnology company OSE Immunotherapeutics SA (Euronext Paris:OSE) on Friday reported positive topline results from the Phase 2 TEDOVA trial evaluating Tedopi, with or without p...