Blog
RSS FeedPosted by Michael Wonder on 23 Feb 2023
US FDA approves Sanofi's bleeding disorder therapy
24 February 2023 - The US FDA has approved French drug maker Sanofi's therapy to treat a type of inherited ...
Posted by Michael Wonder on 23 Feb 2023
Octapharma USA requests FDA approval for wilate VWD prophylaxis supplement
23 February 2023 - Biologics license application supplement supported by study evaluating efficacy and safety of wilate prophylaxis in adults and ...
Posted by Michael Wonder on 02 Aug 2022
Novo Nordisk receives FDA approval for Rebinyn for routine prophylaxis to prevent bleeding in people living with haemophilia B
29 July 2022 - Novo Nordisk announced today that the US FDA has approved the supplemental biologics license application for Rebinyn, ...
Posted by Michael Wonder on 01 Jun 2022
FDA grants efanesoctocog alfa breakthrough therapy designation for haemophilia A
1 June 2022 - Designation is based on XTEND-1 Phase 3 study data demonstrating a clinically meaningful prevention of bleeds and ...
Posted by Michael Wonder on 28 Feb 2022
GC Pharma receives complete response letter from the U.S. FDA for Alyglo
27 February 2022 - GC Pharma today announced that it has received a complete response letter from the U.S. FDA in ...
Posted by Michael Wonder on 01 Feb 2022
FDA approves prophylactic treatment with Vonvendi [von Willebrand factor (recombinant)] for adult patients living with severe type 3 von Willebrand disease
31 January 2022 - Vonvendi [von Willebrand factor (recombinant)] is the first and only treatment approved for routine prophylaxis to reduce ...
Posted by Michael Wonder on 07 Dec 2021
FDA approves Octapharma’s Cutaquig 16.5% for paediatric PI patients, providing flexible treatment options
7 December 2021 - Families, providers can utilise flexible infusion schedule to meet patient needs. ...
Posted by Michael Wonder on 30 Aug 2021
FDA orphan drug approval: Octapharma’s Octagam 10% receives 7 years of market exclusivity for adult dermatomyositis
30 August 2021 - Octagam 10% expected to become the first treatment option for adults with rare immune-mediated inflammatory disease. ...
Posted by Michael Wonder on 03 Aug 2021
FDA approves new Berinert (C1 esterase inhibitor, human (intravenous)) administration kit for increased patient convenience
3 August 2021 - CSL Behring has received U.S. FDA approval for its supplemental request for co-packaging of a convenience ...
Posted by Michael Wonder on 20 Jul 2021
FDA approves Octapharma’s Octagam 10% for adult dermatomyositis
20 July 2021 - FDA approval based on positive results of international, multi-center ProDERM study. ...
Posted by Michael Wonder on 28 Jun 2021
Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in factor VII deficiency
28 June 2021 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for Marzeptacog alfa (activated), MarzAA, ...
Posted by Michael Wonder on 04 Jun 2021
FDA approves first treatment for patients with plasminogen deficiency, a rare genetic disorder
4 June 2021 - Today, the U.S. FDA approved Ryplazim (plasminogen, human-tmvh) for the treatment of patients with plasminogen deficiency type ...
Posted by Michael Wonder on 05 May 2021
US FDA accepts GC Pharma’s biologics license application for immunoglobulin 'GC5107'
5 May 2021 - A significant milestone towards entering the world's largest plasma product marketplace. ...
Posted by Michael Wonder on 28 Apr 2021
FDA begins review of GC Pharma’s blood product for marketing authorisation
27 April 2021 - The U.S. FDA has entered a full review of GC Pharma’s intravenous immunoglobulin therapy GC5107 for ...
Posted by Michael Wonder on 05 Apr 2021
FDA approvals strengthen Octapharma USA paediatric critical care product portfolio
30 March 2021 - Octaplas and fibryga receive new product labeling following FDA’s approval of BLA supplements to update therapy ...