Blog
RSS FeedPosted by Michael Wonder on 23 Jun 2017
FDA approves first subcutaneous C1 esterase Inhibitor to treat rare genetic disease
22 June 2017 - The U.S. FDA today approved Haegarda, the first C1 esterase inhibitor (human) for subcutaneous administration to ...
Posted by Michael Wonder on 07 Jun 2017
Refixia (nonacog beta pegol; N9-GP) approved in the EU
6 June 2017 - Novo Nordisk today announced that the European Commission has granted marketing authorisation for Refixia for the ...
Posted by Michael Wonder on 01 Jun 2017
Novo Nordisk receives US FDA approval of Rebinyn (nonacog beta pegol; N9-GP)
31 May 2017 - Novo Nordisk today announced that the US FDA has approved the biologics license application for Rebinyn ...
Posted by Michael Wonder on 20 Apr 2017
Therapeutic Goods Administration approves Afstyla - CSL Behring's novel recombinant haemophilia A treatment
19 April 2017 - In clinical trials, patients undergoing prophylaxis with Afstyla experienced a median annualised spontaneous bleeding rate of ...
Posted by Michael Wonder on 06 Apr 2017
Prometic completes the filing of its plasminogen biologics license application with the U.S. FDA
5 April 2017 - Prometic Life Sciences announced today that it has completed the filing of its plasminogen biologics license ...
Posted by Michael Wonder on 17 Mar 2017
Shire receives European approval for label extension of Cinryze to prevent and treat hereditary angioedema (HAE) attacks in paediatric patients with HAE
16 March 2017 - Cinryze is now the first and only hereditary angioedema treatment approved for routine prevention in paediatrics. ...
Posted by Michael Wonder on 09 Feb 2017
FDA approves Bio Products Laboratory's Gammaplex 10% for treatment of primary immunodeficiency and chronic immune thrombocytopenic purpura
8 February 2017 - Bio Products Laboratory today announced that the U.S. FDA has approved Gammaplex 10% (immune globulin intravenous ...
Posted by Michael Wonder on 31 Jan 2017
uniQure announces FDA breakthrough therapy designation for AMT-060 in haemophilia B
30 January 2017 - uniQure today announced that AMT-060, its proprietary, investigational gene therapy in patients with severe haemophilia ...
Posted by Michael Wonder on 09 Jan 2017
Afstyla (rFVIII) for haemophilia A, receives European Commission approval
9 January 2017 - CSL today announced that the European Commission has granted marketing authorisation for CSL Behring’s Afstylta [recombinant ...
Posted by Michael Wonder on 28 Dec 2016
Shire announces FDA approval of Adynovate [anti-haemophilic factor (recombinant), PEGylated] for use in children and surgical settings
27 December 2016 - New FDA-approved indications for Adynovate provides more haemophilia A patients access to proven prophylaxis with a ...
Posted by Michael Wonder on 20 Dec 2016
ProMetic initiates rolling submission of its biologics license application for plasminogen with U.S. FDA
19 December 2016 - ProMetic Life Sciences announced today that it has initiated the rolling submission of its biologics license ...
Posted by Michael Wonder on 15 Dec 2016
Health Canada approves CSL Behring’s Afstyla for the treatment of haemophilia A
14 December 2016 - Afstyla is the first and only single-chain recombinant factor VIII for haemophilia A, specifically designed for ...
Posted by Michael Wonder on 20 Nov 2016
TGA approves Grifols' Prolastin C
17 November 2016 - The TGA has approved Grifols' new alfa-1-proteinase inhibitor. ...
Posted by Michael Wonder on 14 Nov 2016
CHMP recommendation for CSL's Afstyla (rFVIII-SC)
14 November 2016 - CSL today announced that the EMA's CHMP has recommended granting marketing authorisation for CSL Behring’s Afstyla [recombinant ...
Posted by Michael Wonder on 31 Oct 2016
Alprolix approved in Switzerland for the treatment of haemophilia B
28 October 2016 - Alprolix approved in Switzerland for the treatment of haemophilia B ...