Blog
RSS FeedPosted by Michael Wonder on 21 May 2025
US FDA grants approval for Jivi anti-hemophilic factor (recombinant), PEGylated-aucl in paediatric patients 7 to under 12 years of age with haemophilia A
19 May 2025 - Bayer announced that the US FDA has approved Jivi, a recombinant DNA-derived, extended half-life factor VIII ...
Posted by Michael Wonder on 02 Apr 2025
Efanesoctocog alfa for the treatment and prevention of bleeding episodes in patients with haemophilia A (final guidance)
2 April 2025 - NICE has published final evidence-based recommendations on the use of efanesoctocog alfa (Altuvoct) for the treatment ...
Posted by Michael Wonder on 28 Mar 2025
Takeda’s HyQvia receives expanded market authorisation as maintenance therapy for chronic inflammatory demyelinating polyneuropathy
27 March 2025 - HyQvia is the only up to once monthly (every 2, 3 or 4 weeks) immunoglobulin subcutaneous ...
Posted by Michael Wonder on 18 Mar 2025
Cellphire Therapeutics CLPH-511 fast track designation granted
17 March 2025 - Cellphire Therapeutics today announced that the US FDA has granted fast track designation for CLPH-511 (frozen activated ...
Posted by Michael Wonder on 15 Feb 2025
Efanesoctocog alfa approved to prevent and treat bleeding in children and adults with severe or moderate haemophilia A
14 February 2025 - The MHRA has today approved efanesoctocog alfa (Altuvoct) to be used to treat and prevent bleeding in ...
Posted by Michael Wonder on 12 Jan 2025
Important milestone for Biotest: biologics license application for fibrinogen submitted to the US FDA
9 January 2025 - The biologics license application for Biotest’s fibrinogen has been submitted to the US FDA. ...
Posted by Michael Wonder on 06 Dec 2024
US FDA approves StemCyte biologics license application for Regenecyte cord blood cell therapy product
22 November 2024 - StemCyte announced today that the US FDA has approved the Biologics License Application for its HPC, cord ...
Posted by Michael Wonder on 03 Aug 2024
FDA approves additional indication for Fibryga for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency, potentially ushering in a new standard of care
1 August 2024 - Octapharma has announced the expanded approval of fibryga, fibrinogen (human) lyophilised powder for Reconstitution, for fibrinogen replacement ...
Posted by Michael Wonder on 03 Jul 2024
CSL Behring’s haemophilia B drug Idelvion gets insurance coverage
2 July 2024 - CSL Behring's long-acting hemophilia B treatment Idelvion (albutrepenonacog alfa) has come to receive reimbursement in Korea. ...
Posted by Michael Wonder on 22 Jun 2024
Takeda's HyQvia approved as replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in paediatric patients 2 years of age and older
21 June 2024 - Takeda Canada is pleased to announce that Health Canada has expanded the marketing authorisation for HyQvia (normal ...
Posted by Michael Wonder on 19 Jun 2024
European Commission grants Sobi marketing authorisation for Altuvoct for treatment of haemophilia A
19 June 2024 - Sobi today announced the European Commission has granted marketing authorisation for Altuvoct's (efanesoctocog alfa), for the ...
Posted by Michael Wonder on 18 Jun 2024
Grifols’ Biotest receives FDA approval for innovative Yimmugo immunoglobulin to treat primary immunodeficiencies
17 June 2024 - Launching Yimmugo in the US will over time significantly add to Grifols Group sales and underpins ...
Posted by Michael Wonder on 15 Jun 2024
Extremely rare disease drug Ceprotin clears major hurdle to reimbursement
14 June 2024 - Ceprotin (protein C concentrate), an ultra-rare disease treatment developed by Takeda Pharmaceutical Korea, has passed the ...
Posted by Michael Wonder on 17 May 2024
Efanesoctocog alfa for the treatment and prevention of bleeding episodes in patients with haemophilia A
17 May 2024 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...
Posted by Michael Wonder on 14 May 2024
FDA approves updated Altuviiio label with expanded paediatric data confirming highly effective bleed protection in children with haemophilia A
10 May 2024 - Full results from the pivotal XTEND-Kids study added to the US label, building on the interim data ...