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RSS FeedPosted by Michael Wonder on 19 Oct 2021
Health Canada receives submission from Pfizer-BioNTech to authorise the use of Comirnaty COVID-19 vaccine in children 5 to 11 years of age
18 October 2021 - Today, Health Canada received a submission from Pfizer-BioNTech seeking an authorisation for the use of its Comirnaty ...
Posted by Michael Wonder on 07 Oct 2021
Moderna asks Health Canada to approve COVID-19 vaccine booster shot
5 October 2021 - Moderna has applied for Canadian approval of a third dose of its COVID-19 vaccine, the company ...
Posted by Michael Wonder on 17 Sep 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full Health Canada approval for individuals 12 years and older
16 September 2021 - Health Canada Notice of Compliance is based on a comprehensive submission package including six month efficacy ...
Posted by Michael Wonder on 16 Sep 2021
Moderna announces Health Canada approves its COVID-19 vaccine
16 September 2021 - Moderna today announced Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), which ...
Posted by Michael Wonder on 29 Aug 2021
Moderna COVID-19 vaccine gets Health Canada approval for kids 12+
27 August 2021 - As the Delta variant rages through unvaccinated populations in Canada ahead of the back-to-school season, children ...
Posted by Michael Wonder on 16 Aug 2021
Merck Canada initiates rolling submission to Health Canada for molnupiravir, an investigational oral therapeutic agent for the treatment of COVID-19
13 August 2021 - Merck today announced the initiation of a rolling submission to Health Canada for molnupiravir, an investigational twice ...
Posted by Michael Wonder on 03 Aug 2021
Celltrion Healthcare announces acceptance and priority review by Health Canada of New Drug Submission for its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59)
2 August 2021 - Celltrion Healthcare Canada remains committed to working closely with Health Canada to make its monoclonal antibody treatment ...
Posted by Michael Wonder on 02 Aug 2021
GSK receives authorization under Health Canada's Interim Order for sotrovimab for Injection to treat COVID-19 in high-risk adults and adolescents
30 July 2021 - GSK announced today that Health Canada has granted an Interim Order Authorisation for sotrovimab for Injection (sotrovimab, ...
Posted by Michael Wonder on 10 Jun 2021
Health Canada grants interim order authorisation for casirivimab and imdevimab for the treatment of mild to moderate COVID-19
10 June 2021 - Interim data shows treatment with casirivimab and imdevimab resulted in a statistically significant reduction in viral ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for authorisation with Health Canada for its COVID-19 vaccine in adolescents
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 20 May 2021
Canada's change to Pfizer vaccine storage temperature has major implications on rollout
19 May 2021 - Health Canada now recommends storing Pfizer vaccine at fridge temperatures for up to 1 month. ...
Posted by Michael Wonder on 05 May 2021
Health Canada authorises use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age
5 May 2021 - Today, Health Canada authorised the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 ...
Posted by Michael Wonder on 03 May 2021
Statement from Health Canada on Janssen COVID-19 vaccines and Emergent BioSolutions
30 April 2021 - Health Canada continues to ensure the quality and safety of vaccines coming into Canada by working ...
Posted by Michael Wonder on 27 Apr 2021
Health Canada initiates the review of the rolling submission for the first Canadian based COVID-19 vaccine candidate
23 April 2021 - Medicago is pleased to announce that Health Canada received for review the first portion of Medicago’s ...
Posted by Michael Wonder on 15 Apr 2021
Health Canada stands by approval of AstraZeneca, Johnson & Johnson COVID-19 vaccines
14 April 2021 - Health Canada is standing by the approval of the Oxford-AstraZeneca and Johnson & Johnson vaccines for ...