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RSS FeedPosted 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 14 Jul 2023
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. ...
Posted by Michael Wonder on 12 Jul 2023
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 ...
Posted by Michael Wonder on 06 Jul 2023
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 ...
Posted by Michael Wonder on 30 Jun 2023
Moderna initiates rolling submission to Health Canada for updated COVID-19 vaccine
29 June 2023 - Health Canada submission follows international recommendations to develop monovalent XBB.1.5 COVID-19 vaccines. ...
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 30 May 2023
Valneva files for Chikungunya vaccine authorisation with Health Canada
30 May 2023 - Valneva today announces the filing of a regulatory application with Health Canada for marketing approval of ...
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 ...
Posted by Michael Wonder on 16 May 2023
Health Canada accepts new drug submission for lecanemab as treatment for early Alzheimer’s disease
15 May 2023 - Eisai and Biogen announced today that Health Canada has accepted a new drug submission for lecanemab for ...