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RSS FeedPosted 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 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 03 Aug 2023
Jazz Pharmaceuticals enters into letter of intent with the pan-Canadian Pharmaceutical Alliance for Rylaze, helping address the unmet need of acute lymphoblastic leukaemia and lymphoblastic lymphoma patients across Canada
2 August 2023 - Jazz Pharmaceuticals today announced that the Company has entered into a letter of intent with the pan-Canadian ...
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. ...
Posted by Michael Wonder on 23 Jul 2023
Health Canada approves Trodelvy (sacituzumab govitecan) in pre-treated HR+/HER2- metastatic breast cancer
20 July 2023 - Trodelvy has now improved survival in both pre-treated HR+/HER2- metastatic breast cancer and in second-line metastatic ...
Posted by Michael Wonder on 30 Jun 2023
Endo announces approval of Xcopri (cenobamate tablets) in Canada
29 June 2023 - Endo International announced today that Paladin Labs, an Endo operating company, received Health Canada's approval of ...
Posted by Michael Wonder on 27 Jun 2023
Sun Pharma announces Health Canada approval of Absorica LD (isotretinoin capsules) for treatment of severe nodular acne
26 June 2023 - A new formulation of isotretinoin, the first in over a decade and the only micronised formulation ...
Posted by Michael Wonder on 20 Jun 2023
Sun Pharma announces Health Canada approval of Winlevi (clascoterone cream 1%) for topical treatment of acne
19 June 2023 - Winlevi is the first and only topical androgen receptor inhibitor, and the newest Health Canada-approved formulation to ...
Posted by Michael Wonder on 15 Jun 2023
Health Canada authorises Akeega (niraparib and abiraterone acetate) dual action tablets for targeted treatment of patients with metastatic castration-resistant prostate cancer with BRCA (1/2) gene mutations
14 June 2023 - Approval for Akeega is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision ...
Posted by Michael Wonder on 12 Jun 2023
Is Canada missing out? An assessment of drugs approved internationally between 2016 and 2020 and not submitted for Health Canada review
12 June 2023 - One-third of the new active substances approved in the United States and Europe between 2016 and ...
Posted by Michael Wonder on 31 May 2023
Brukinsa approved in Canada for the treatment of chronic lymphocytic leukaemia
30 May 2023 - BeiGene’s Bruton's tyrosine kinase inhibitor is approved in more than 65 markets globally. ...
Posted by Michael Wonder on 23 May 2023
Health Canada’s position on the CADTH guidance for reporting RWE to support decision-making
18 May 2023 - Canada’s CADTH collaborated with Health Canada and other stakeholders to develop the guidance for reporting real world ...