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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Health Canada approves Lynparza in combination with abiraterone and prednisone or prednisolone for patients with BRCA mutated metastatic castration-resistant prostate cancer

13 July 2023 - Conditional approval based on data from Phase 3 PROpel trial. ...

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Lupin Announces Health Canada approval of tiotropium bromide inhalation powder for treatment of COPD

11 July 2023 - Lupin announced that on 26 May 2023, its Canada subsidiary, Lupin Pharma Canada received approval from ...

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Dexcom G7 receives Health Canada approval: next generation continuous glucose monitoring system with unmatched accuracy coming to Canadians

4 July 2023 - Dexcom announced today that Health Canada has approved the next generation Dexcom G7 Continuous Glucose Monitoring System ...

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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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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. ...

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Health Canada Approves AbbVie's Rinvoq (upadacitinib) for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis

9 May 2023 - Approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which Rinvoq ...

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Rhythm Pharmaceuticals announces Health Canada approval of Imcivree setmelanotide injection for weight management in Bardet-Biedl syndrome or genetically-confirmed biallelic POMC, PCSK1, or LEPR deficiency

8 May 2023 - Approval granted following a priority review by Health Canada. ...

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Dupixent (dupilumab injection) is now approved in Canada for the treatment of adult and adolescent patients (12+) with eosinophilic esophagitis

4 May 2023 - This is the eighth indication for Dupixent in Canada and its first in gastroenterology. ...

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Health Canada approves Quviviq (daridorexant) for the management of adult patients with insomnia

3 May 2023 - Quviviq is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset ...

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