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RSS FeedPosted by Michael Wonder on 14 Sep 2022
Lupin receives Health Canada approval for Rymti (biosimilar etanercept)
13 September 2022 - Rymti is Lupin’s biosimilar etanercept approved for all indications of the reference product. ...
Posted by Michael Wonder on 14 Sep 2022
Health Canada approves Keytruda (pembrolizumab) as adjuvant treatment for adults and children with stage IIB or IIC melanoma following complete resection
13 September 2022 - Approval is based on the Phase 3 KEYNOTE-716 trial. ...
Posted by Michael Wonder on 09 Sep 2022
Health Canada approves Pfizer-BioNTech COVID-19 vaccine for kids under 5
9 September 2022 - Health Canada approves Pfizer-BioNTech COVID-19 vaccine for kids under 5. ...
Posted by Michael Wonder on 08 Sep 2022
Health Canada approves Pluvicto as first targeted radioligand therapy for progressive PSMA positive metastatic castration-resistant prostate cancer
7 September 2022 - Novel mechanism of action of Pluvicto binds to target PSMA positive cancer cells, delivering radiation treatment directly ...
Posted by Michael Wonder on 01 Sep 2022
Health Canada authorises first bivalent COVID-19 booster for adults 18 years and older
1 September 2022 - Today, Health Canada authorised an adapted version of the Moderna Spikevax COVID-19 vaccine. ...
Posted by Michael Wonder on 23 Aug 2022
Health Canada approves Opdivo (nivolumab) with chemotherapy as neo-adjuvant treatment for adult patients with resectable non-small-cell lung cancer
23 August 2022 - First and only immunotherapy-based treatment for use before surgery for non-small-cell lung cancer in Canada. ...
Posted by Michael Wonder on 20 Aug 2022
Health Canada approves COVID-19 booster dose for kids 5 to 11
19 August 2022 - The 10 mcg dose can be given at least 6 months after primary series is completed. ...
Posted by Michael Wonder on 16 Aug 2022
Otsuka Canada Pharmaceutical announces Health Canada approval of Korsuva (difelikefalin) for the treatment of moderate to severe pruritus associated with chronic kidney disease in adult haemodialysis patients
16 August 2022 - Launch of Korsuva in Canada is expected in the second quarter of 2023. ...
Posted by Michael Wonder on 11 Aug 2022
Lynparza receives Health Canada approval as adjuvant treatment for patients with germline BRCA mutated HER2 negative high-risk early breast cancer
11 August 2022 - First and only approved medicine targeting germline BRCA mutations in high-risk early breast cancer. ...
Posted by Michael Wonder on 09 Aug 2022
Paladin Labs announces Health Canada's filing acceptance of cenobamate tablets as an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy
8 August 2022 - Paladin Labs announced today that Health Canada has accepted its new drug submission for cenobamate tablets as ...
Posted by Michael Wonder on 21 Jul 2022
Pfizer announces Prevnar 20 (pneumococcal 20 valent conjugate vaccine) is now available in Canada for the prevention of pneumonia and invasive pneumococcal disease in adults 18 years of age and older
21 July 2022 - Prevnar 20 is the first conjugate vaccine indicated to help protect against 20 serotypes responsible for ...
Posted by Michael Wonder on 21 Jul 2022
Health Canada approves AbbVie's Rinvoq (upadacitinib) for the treatment of adults with active ankylosing spondylitis
20 July 2022 - Approval is supported by efficacy and safety data of two pivotal studies in which Rinvoq demonstrated improvements ...
Posted by Michael Wonder on 15 Jul 2022
Health Canada authorises use of Moderna COVID-19 vaccine in children 6 months to 5 years of age
14 July 2022 - Today, Health Canada authorised the use of the Moderna Spikevax COVID-19 vaccine in children 6 months to ...
Posted by Michael Wonder on 11 Jul 2022
Arcutis Biotherapeutics announces Health Canada accepts for review the new drug submission for roflumilast cream for adults and adolescents with plaque psoriasis
11 July 2022 - Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as ...
Posted by Michael Wonder on 06 Jul 2022
Regulatory submission for GSK's daprodustat accepted into Health Canada review
6 July 2022 - Canadian regulatory submission acceptance follows that of the US FDA and the EMA as well as ...