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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Pay for plasma collection coming to Alberta by end of the year

14 February 2021 - Repeal of NDP bill last fall clears way for Canadian Plasma Resources to set up shop. ...

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U.S. FDA approves Panzyga for the treatment of adults with chronic inflammatory demyelinating polyneuropathy

12 February 2021 - The first and only FDA approved intravenous immunoglobulin with two maintenance dosing options for  chronic inflammatory ...

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Catalyst Biosciences receives FDA fast track designation for subcutaneous MarzAA for the treatment of episodic bleeding in haemophilia A or B with inhibitors

2 December 2020 - Catalyst Biosciences today announced the U.S. FDA has granted fast track designation for marzeptacog alfa (activated) – ...

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Liminal BioSciences announces FDA extension of review period for Ryplazim (plasminogen) BLA

9 November 2020 - PDUFA date extended by FDA from 5 March 2021 to 5 June 2021. ...

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Extra transparency measures for COVID-19 vaccines and therapeutics

30 October 2020 - Today the EMA has implemented two further extra transparency measures for COVID-19 medicines, by publishing both ...

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