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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Lilly announces agreement with U.S. government to supply 300,000 vials of investigational neutralising antibody bamlanivimab (LY-CoV555) in an effort to fight COVID-19

28 October 2020 - Initial agreement for 300,000 vials with potential for purchase of an additional 650,000 vials. ...

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Trump’s antibody ‘cure’ will be in short supply

20 October 2020 - All the weak points of American health care — testing delays, communication breakdowns, inequity — are working ...

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Octapharma announces FDA approval of updated Nuwiq Prescribing Information to include immunogenicity data in previously untreated patients

19 October 2020 - Octapharma is pleased to announce that the U.S. FDA has approved an updated Prescribing Information for Nuwiq, ...

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Regeneron asks FDA for emergency approval for drug that Trump claimed cured him

7 October 2020 - The company said that doses of the unproven treatment would be available for 50,000 patients. It’s impossible ...

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U.S. FDA approves Haegarda (C1 esterase inhibitor subcutaneous [human]) for prevention of hereditary angioedema attacks in paediatric patients

28 September 2020 - Haegarda is the first and only subcutaneous prophylactic hereditary angioedema treatment approved for children 6 years of ...

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Medicines for haemophilia remain in the high-cost protection after TLV's reconsideration

25 September 2020 - The costs of factor IX concentrate, which is used in the treatment of haemophilia B, are reduced ...

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