The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) submitted by Pfizer for haemophilia B gene therapy, fidanacogene elaparvovec.
28 Jun 2023
28 Apr 2022
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.
03 Sep 2021
Swedish Orphan Biovitrum (Sobi) has agreed a $8bn (SEK69.4bn) takeover offer from Advent International and Singapore’s wealth fund GIC.
15 Mar 2021
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.
19 Feb 2021
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.