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RSS FeedPosted 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 29 Aug 2023
Health Canada accepts Valneva’s Chikungunya vaccine license application for review
29 August 2023 - Valneva today announced that Health Canada has completed screening validation of the Company’s regulatory application for ...
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
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 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 ...