FDA accepts BLA for Pfizer’s haemophilia B gene therapy
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec.
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec.
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced the receipt of marketing authorisation from European Commission for Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus linked with chronic kidney disease (CKD) in adult hemodialysis patients.
Swedish Orphan Biovitrum (Sobi) has agreed a $8bn (SEK69.4bn) takeover offer from Advent International and Singapore’s wealth fund GIC.
Japan-based, R&D-driven Takeda Pharmaceutical Company Limited has submitted a New Drug Application (NDA) for lanadelumab to the Ministry of Health, Labour and Welfare (MHLW) in Japan.
The U.S. Food and Drug Administration (FDA) has granted efanesoctocog alfa – earlier termed BIVV001 (rFVIIIFc-VWF-XTEN) – Fast Track Designation (FTD) for the treatment of patients suffering from hemophilia A.