Blog
RSS FeedPosted 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 13 Aug 2021
GC Pharma announces GreenGene F approval in China for the treatment of haemophilia A
12 August 2021 - GreenGene F now approved in China, provides more haemophilia A patients access to proven therapy. ...
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 31 May 2021
Campaign launched for life-sustaining treatment access across Canada
31 May 2021 - Alpha-1 Canada publicly launched Access for Alphas today, a campaign aimed at raising the awareness of alfa-1 ...
Posted by Michael Wonder on 12 May 2021
TGA approves Octapharma's Cutaquig
12 May 2021 - The TGA has deemed it to be a new biological entity. Others will beg to differ. ...
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 ...
Posted by Michael Wonder on 02 Mar 2021
GC Pharma submits biologics license application to US FDA for immune globulin 'GC5107'
25 February 2021 - Submission for entering the world’s largest US marketplace. ...
Posted by Michael Wonder on 01 Mar 2021
LFB announces that the EMA has accepted for filing the marketing authorisation application for eptacog beta (activated), a recombinant coagulation factor VIIa
1 March 2021 - In addition, LFB announces the online publication of the exploratory in vitro study results on eptacog beta ...
Posted by Michael Wonder on 25 Feb 2021
Teleflex announces submission of biologics license application for its investigational freeze dried plasma
24 February 2021 - Submission is eligible for priority review and accelerated approval. ...
Posted by Michael Wonder on 19 Feb 2021
Efanesoctocog alfa granted FDA fast track designation for treatment of haemophilia A
18 February 2021 - Efanesoctocog alfa, previously known as BIVV001, is an investigational factor VIII replacement therapy that has the potential ...