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RSS FeedPosted by Michael Wonder on 24 Mar 2021
Seqirus ready to reinforce Canada's influenza pandemic preparedness plans
23 March 2021 - Health Canada's approval of Foclivia (an adjuvanted, egg-based A strain H5N1 pandemic influenza vaccine) meets key requirement ...
Posted by Michael Wonder on 24 Mar 2021
Health Canada says AstraZeneca shot is safe as U.S. questions vaccine's clinical trial data
23 March 2021 - U.S. regulator says AstraZeneca may have included 'outdated' data when releasing clinical trial results. ...
Posted by Michael Wonder on 23 Mar 2021
Health Canada approves Kesimpta, the first and only self-administered targeted B-cell therapy for relapsing remitting multiple sclerosis
23 March 2021 - Approval is based on two Phase 3 studies (ASCLEPIOS I & II) demonstrating significant reductions in risk ...
Posted by Michael Wonder on 19 Mar 2021
Seqirus announces Health Canada approval of expanded age indication of its cell-based quadrivalent influenza vaccine for people two years of age and older
18 March 2021 - Seqirus announced that Health Canada has approved Flucelvax Quadrivalent (influenza vaccine), its cell-based quadrivalent influenza vaccine, for ...
Posted by Michael Wonder on 18 Mar 2021
Novartis' Kisqali (ribociclib) product monograph in Canada now includes MONALEESA-3 data demonstrating statistically significant improvement in overall survival in postmenopausal women with HR+/HER2- advanced breast cancer
18 March 2021 - Kisqali is currently the only CDK4/6 inhibitor that has demonstrated statistically significant improvement in overall survival (key ...
Posted by Michael Wonder on 17 Mar 2021
Health Canada approves new indication for lung cancer treatment option Alunbrig
17 March 2021 - First-line indication offers Canadians with advanced lung cancer new treatment options. ...
Posted by Michael Wonder on 17 Mar 2021
Health Canada approves Increlex, first and only recombinant human insulin-like growth factor-1 therapy in Canada for the treatment of severe growth failure associated with ultra rare condition in children and adolescents
16 March 2021 - Ipsen Biopharmaceuticals today announced the commercial availability of Increlex (mecasermin) for the treatment of growth failure in ...
Posted by Michael Wonder on 16 Mar 2021
Health Canada approves Perjeta for use pre-surgery in patients with aggressive early breast cancer
16 March 2021 - New approval provides Canadian patients with HER2 positive early breast cancer a proven treatment regimen in a ...
Posted by Michael Wonder on 08 Mar 2021
Health Canada approves Keytruda (pembrolizumab) as first-line treatment for adults with metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer
8 March 2021 - Approval based on significant progression-free survival findings from Phase 3 KEYNOTE-177 trial. ...
Posted by Michael Wonder on 07 Mar 2021
Canada authorises one-shot COVID-19 vaccine from Johnson & Johnson
5 March 2021 - The first one-shot COVID-19 vaccine from Johnson & Johnson has been authorized by Health Canada, making ...
Posted by Michael Wonder on 03 Mar 2021
Health Canada approves Brukinsa (zanubrutinib) for the treatment of Waldenström’s macroglobulinaemia
2 March 2021 - Approval is based on the Phase 3 ASPEN trial of Brukinsa compared to ibrutinib. ...
Posted by Michael Wonder on 02 Mar 2021
EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine
2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...
Posted by Michael Wonder on 01 Mar 2021
Health Canada approves AstraZeneca's COVID-19 vaccine
26 February 2021 - Canada's regulator estimates vaccine's efficacy at 62.1 per cent. ...
Posted by Michael Wonder on 26 Feb 2021
Emgality (galcanezumab) now approved for use in Canada for the treatment of episodic cluster headache
25 February 2021 - The first and only anti-CGRP treatment with dual indications. ...
Posted by Michael Wonder on 26 Feb 2021
Medexus announces expanded availability of Gleolan in Canada
25 February 2021 - Medexus Pharmaceuticals announced today that it has initiated the commercial launch of Gleolan in Canada, which had ...