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RSS FeedPosted by Michael Wonder on 27 Oct 2023
Health Canada authorises CSL's Hemgenix (etranacogene dezaparvovec) as first gene therapy for haemophilia B
26 October 2023 - CSL's Hemgenix is a one time, single dose treatment for adults with haemophilia B who require ...
Posted by Michael Wonder on 24 Oct 2023
Sumitomo Pharma announces authorisation in Canada of Orogvyx (relugolix) for the treatment of men with advanced prostate cancer
23 October 2023 - Orgovyx is the first and only oral gonadotropin-releasing hormone receptor antagonist approved for advanced prostate cancer ...
Posted by Michael Wonder on 20 Oct 2023
Sumitomo Pharma and Pfizer in Canada receive Health Canada approval for Myfembree
19 October 2023 - Sumitomo Pharma Canada and Pfizer Canada today announced that Health Canada has granted a notice of compliance ...
Posted by Michael Wonder on 18 Oct 2023
AbbVie's Epkinly (epcoritamab) receives Health Canada authorisation with conditions as the first and only subcutaneous bi-specific antibody to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma
17 October 2023 - AbbVie today announced that Epkinly (epcoritamab) has received Health Canada authorisation with conditions. ...
Posted by Michael Wonder on 18 Oct 2023
Health Canada grants market authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 2 to 5 years with at least one F508del mutation
17 October 2023 - Approximately 330 children with cystic fibrosis ages 2-5 years are now eligible for a medicine that ...
Posted by Michael Wonder on 18 Oct 2023
AbbVie's Rinvoq (upadacitinib) receives Health Canada approval as the first and only oral therapy for the treatment of adults with moderately to severely active Crohn's disease
17 October 2023 - Approval is based on results from three Phase 3 clinical trials demonstrating Rinvoq achieved the co-primary outcomes ...
Posted by Michael Wonder on 29 Sep 2023
Pfizer and BioNTech receive Health Canada authorisation for XBB.1.5 adapted monovalent COVID-19 vaccine
28 September 2023 - The updated vaccine is expected to be available in Canada in the coming weeks. ...
Posted by Michael Wonder on 26 Sep 2023
Ultragenyx launches Evkeeza (evinacumab for injection) in Canada for the treatment of homozygous familial hypercholesterolaemia
25 September 2023 - Evkeeza is a first in class medicine approved by Health Canada, the US FDA and European Commission ...
Posted by Michael Wonder on 23 Sep 2023
argenx announces Vyvgart (efgartigimod alfa) authorised for sale by Health Canada for generalised myasthenia gravis
21 September 2023 - Approval based on the positive Phase 3 ADAPT trial (p<0.0001) showing 68% of Vyvgart treated patients were ...
Posted by Michael Wonder on 13 Sep 2023
Health Canada authorises Moderna COVID-19 vaccine targeting the Omicron XBB.1.5 sub-variant
12 September 2023 - Health Canada has authorised the use of the Moderna Spikevax COVID-19 vaccine targeting the Omicron XBB.1.5 ...
Posted by Michael Wonder on 10 Aug 2023
Health Canada approves Alhemo (concizumab injection) for the treatment of patients living with haemophilia A with FVIII inhibitors
9 August 2023 - Health Canada has approved a new indication for Alhemo (concizumab injection) for the treatment of Canadian adolescent ...
Posted by Michael Wonder on 05 Aug 2023
GSK's Arexvy, the first respiratory syncytial virus vaccine for older adults approved in Canada
4 August 2023 - Approval of Arexvy was based on a comprehensive Phase III clinical trial program that showed high vaccine ...
Posted by Michael Wonder on 03 Aug 2023
Health Canada authorises Tecvayli (teclistamab injection), a first in class bispecific antibody for the treatment of patients with relapsed or refractory multiple myeloma
2 August 2023 - Approval for Tecvayli, a subcutaneously administered therapy, is based on results from the Phase 1/2 MajesTEC-1 ...
Posted by Michael Wonder on 26 Jul 2023
Mirum’s Livmarli now authorised in Canada for cholestatic pruritus in patients with Alagille syndrome
25 July 2023 - Approval supported by more than six years of Livmarli data demonstrating improvements in pruritus and serum bile ...
Posted by Michael Wonder on 25 Jul 2023
Health Canada approves AbbVie's Rinvoq (upadacitinib) for the treatment of adults with moderately to severely active ulcerative colitis
25 July 2023 - Approval is based on results from three Phase 3 studies: two for induction and one for maintenance. ...