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. ...

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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. ...

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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 ...

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FDA approves Octapharma’s Octagam 10% for adult dermatomyositis

20 July 2021 - FDA approval based on positive results of international, multi-center ProDERM study. ...

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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, ...

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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 ...

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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 ...

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TGA approves Octapharma's Cutaquig

12 May 2021 - The TGA has deemed it to be a new biological entity. Others will beg to differ. ...

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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. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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. ...

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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 ...

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