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RSS FeedPosted by Michael Wonder on 14 Jun 2025
Xediton Pharmaceuticals announced today the Canadian approval and availability of Vabomere (meropenem-vaborbactam) in Canada
12 June 2025 - Xediton Pharmaceuticals is proud to announce that Vabomere (meropenem-vaborbactam) has been approved by Health Canada and ...
Posted by Michael Wonder on 06 Dec 2024
Esperion announces new drug submissions in Canada for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) treatments to reduce LDL-cholesterol and cardiovascular risk
2 December 2024 - Esperion today announced that it has filed new drug submissions to Health Canada for Nexletol and Nexlizet, ...
Posted by Michael Wonder on 29 Sep 2024
Vertex announces Health Canada acceptance of new drug submission for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
26 September 2024 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review its new drug submission for ...
Posted by Michael Wonder on 12 Sep 2024
Health Canada approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) triple combination topical treatment for acne vulgaris in patients 12 years of age and older
11 September 2024 - Bausch Health today announced the approval by Health Canada of Cabtreo (clindamycin phosphate, adapalene and benzoyl ...
Posted by Michael Wonder on 27 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
Posted by Michael Wonder on 16 Jul 2024
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis aged 2 years and older with certain rare mutations
15 July 2024 - Approximately 200 people with certain rare CF mutations are now eligible for Trikafta. ...
Posted by Michael Wonder on 10 Feb 2024
AbbVie's Vyalev (foslevodopa/foscarbidopa solution) available for the treatment of advanced Parkinson's disease in Canada
8 February 2024 - In clinical trials, patients taking Vyalev achieved the primary endpoint of a reduction in motor fluctuations ...
Posted by Michael Wonder on 03 Dec 2023
Duchesnay is seeking Health Canada approval for a segesterone acetate/ethinyl estradiol contraceptive vaginal system, a new option for women
30 November 2023 - Duchesnay has recently filed a new drug submission to Health Canada for its segesterone acetate/ethinyl estradiol slow ...
Posted by Michael Wonder on 20 Oct 2023
Sumitomo Pharma and Pfizer in Canada receive Health Canada approval for Myfembree
19 October 2023 - Sumitomo Pharma Canada and Pfizer Canada today announced that Health Canada has granted a notice of compliance ...
Posted 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 13 Apr 2023
Vertex announces Health Canada market authorisation for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 1 to <2 years
10 April 2023 - With this approval, approximately 30 children with two copies of the F508del mutation are eligible for ...
Posted by Michael Wonder on 19 Oct 2022
Evusheld receives Health Canada approval for treatment of COVID-19
18 October 2022 - Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase 3 treatment trial. ...
Posted by Michael Wonder on 24 Sep 2022
Bausch Health and Glenmark announce the approval of Ryaltris in Canada
23 September 2022 - Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) treats moderate to severe seasonal allergic rhinitis and associated ...
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 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 ...