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news.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.
Haematology
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28 Jun 2023
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28 Apr 2022
EC grants marketing authorisation for Kapruvia to treat pruritus in hemodialysis patients
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.
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03 Sep 2021
Sobi agrees $8bn takeover offer from Advent and GIC
Swedish Orphan Biovitrum (Sobi) has agreed a $8bn (SEK69.4bn) takeover offer from Advent International and Singapore’s wealth fund GIC.
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15 Mar 2021
Takeda submits New Drug Application for lanadelumab in Japan
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.
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19 Feb 2021
USFDA grants FTD to efanesoctocog alfa for hemophilia A treatment
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.