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 ...

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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 ...

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Medison Pharma announces public formulary listing of Qinlock (ripretinib) in Canadian provinces: Ontario and Quebec for advanced gastro-intestinal stromal tumour treatment

29 September 2023 - Medison Pharma is pleased to announce the public formulary listing of Qinlock in Canadian provinces: Ontario ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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