Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 13 May 2023
Tetra Bio-Pharma cancels new drug submission to Health Canada
11 May 2023 - Tetra Bio-Pharma today announced it has cancelled its new drug submission to Health Canada, without prejudice ...
Posted by Michael Wonder on 10 May 2023
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 ...
Posted by Michael Wonder on 09 May 2023
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. ...
Posted by Michael Wonder on 05 May 2023
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. ...
Posted by Michael Wonder on 04 May 2023
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 ...
Posted by Michael Wonder on 02 May 2023
Libtayo (cemiplimab) in combination with chemotherapy now approved in Canada for the first-line treatment of advanced non-small cell lung cancer
1 May 2023 - Approval marks second first-line indication in NSCLC and fifth indication for Libtayo in Canada. ...
Posted by Michael Wonder on 29 Apr 2023
Arcutis announces Canadian approval of Zoryve (roflumilast) cream 0.3% for treatment of plaque psoriasis in individuals 12 years and older
28 April 2023 - First Zoryve approval outside of the US marks key milestone for Arcutis. ...
Posted by Michael Wonder on 24 Apr 2023
Health Canada approves new antibody drug to help prevent serious RSV in babies
22 April 2023 - Health Canada has approved a new antibody drug to help protect babies from serious illness caused ...
Posted by Michael Wonder on 18 Apr 2023
Health Canada approves Alhemo, the first subcutaneous prophylactic treatment for people living with haemophilia B with inhibitors
17 April 2023 - New treatment option for Canadians living with rare and serious X-chromosome linked congenital bleeding disorder ...