Blog
RSS FeedPosted 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 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 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
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 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 ...
Posted by Michael Wonder on 05 Jul 2022
Health Canada approves the use of Cibinqo (abrocitinib) for the treatment of patients 12 years of age and older with moderate-to-severe atopic dermatitis
4 July 2022 - Pfizer Canada announces today that Health Canada has approved Cibinqo (abrocitinib) for the treatment of patients 12 ...
Posted by Michael Wonder on 28 Jun 2022
Health Canada approves Opdivo (nivolumab) as monotherapy for the adjuvant treatment of adults with urothelial carcinoma at high risk of recurrence after undergoing radical resection of urothelial carcinoma
28 June 2022 - First adjuvant Immunotherapy for patients at high risk of disease recurrence. ...
Posted by Michael Wonder on 24 Jun 2022
Health Canada expands approval of Enhertu for adults with HER2 positive metastatic breast cancer
23 June 2022 - Approval based on the ground-breaking DESTINY-Breast03 Phase 3 trial, showing Enhertu reduced the risk of disease ...
Posted by Michael Wonder on 23 Jun 2022
Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C
22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...
Posted by Michael Wonder on 19 Jun 2022
Canadian regulator OKs Hugel's botulinum toxin product
16 June 2022 - Hugel said Thursday that it has obtained product approval from Health Canada for its botulinum toxin ...
Posted by Michael Wonder on 13 Jun 2022
Amylyx Pharmaceuticals announces Health Canada approval of Albrioza for the treatment of ALS
13 June 2022 - Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ...
Posted by Michael Wonder on 08 Jun 2022
Health Canada approves Tabrecta: targeted cancer therapy for locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations
8 June 2022 - Newest treatment for lung cancer reinforces Novartis commitment to developing innovative therapies that improve outcomes for ...