Blog
RSS FeedPosted by Michael Wonder on 13 Sep 2024
Health Canada approves Keytruda as monotherapy for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options
12 September 2024 - Merck announced that Health Canada has granted approval of Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy ...
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 11 Sep 2024
Health Canada approves AbbVie's Constella (linaclotide) for the treatment of functional constipation in paediatric patients 6 to 17 years of age
10 September 2024 - Submission is based on positive Phase 3 study data demonstrating linaclotide (72 mcg) resulted in increases ...
Posted by Michael Wonder on 05 Sep 2024
Winrevair (sotatercept) is now authorised for use in Canada for adults with pulmonary arterial hypertension
4 September 2024 - Merck announced that Winrevair (sotatercept) is now authorised for use in Canada in combination with standard ...
Posted by Michael Wonder on 28 Aug 2024
Kye Pharmaceuticals announces approval in Canada for ACCRUFeR (ferric maltol) for the treatment of iron deficiency anaemia in adult patients
27 August 2024 - Kye Pharmaceuticals today announced that ACCRUFeR (ferric maltol) has received market authorisation as a prescription medicine in ...
Posted by Michael Wonder on 25 Aug 2024
Padcev (enfortumab vedotin) in combination with pembrolizumab approved by Health Canada to treat advanced bladder cancer
22 August 2024 - Padcev plus pembrolizumab approved based on EV-302 trial. ...
Posted by Michael Wonder on 25 Aug 2024
Henlius trastuzumab receives approval in Canada
22 August 2024 - Shanghai Henlius Biotech announced that the company's business partner, Accord Healthcare has received marketing approval (Notice of ...
Posted by Michael Wonder on 25 Aug 2024
Health Canada approves Keytruda for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer with no prior systemic therapy for metastatic urothelial cancer, in combination with enfortumab vedotin
22 August 2024 - Approval is based on the Phase 3 KEYNOTE-A39 trial. ...
Posted by Michael Wonder on 25 Aug 2024
Lupin receives Health Canada approval for biosimilar pegfilgrastim
23 August 2024 - Lupin today announced that it has received approval from Health Canada for its biosimilar Pegfilgrastim. ...
Posted by Michael Wonder on 02 Aug 2024
Health Canada approves Celltrion’s Steqeyma, a biosimilar to Stelara (ustekinumab) for the treatment of multiple chronic inflammatory conditions
1 August 2024 - Steqeyma, is now approved in Canada for adult patients with plaque psoriasis as well as adults with ...
Posted by Michael Wonder on 30 Jul 2024
Health Canada authorizes Vabysmo (faricimab injection) for the treatment of macular oedema secondary to retinal vein occlusion
29 July 2024 - This is the third indication for Vabysmo, in addition to neovascular or 'wet' age-related macular degeneration and ...
Posted by Michael Wonder on 25 Jul 2024
Health Canada grants full approval to Jemperli for the treatment of patients with recurrent or advanced dMMR/MSI-H endometrial cancer
24 July 2024 - The conversion of this indication from Notice of Compliance to full approval is based on long term ...
Posted by Michael Wonder on 24 Jul 2024
Voydeya approved in Canada as add-on therapy to ravulizumab or eculizumab for adults with the rare disease PNH who have residual haemolytic anaemia due to extravascular haemolysis
23 July 2024 - ALPHA Phase 3 trial showed first in class, oral, factor D inhibitor as add-on to Ultomiris ...
Posted by Michael Wonder on 18 Jul 2024
Zilbrysq (zilucoplan injection) now approved for adults with generalised myasthenia gravis in Canada
17 July 2024 - Health Canada's approval is supported by the pivotal Phase 3 RAISE study in generalised myasthenia gravis in adult ...
Posted by Michael Wonder on 17 Jul 2024
Health Canada authorizes Alecensaro (alectinib) as the first and only adjuvant treatment for people with ALK positive early stage lung cancer
16 July 2024 - Alecensaro reduced the risk of disease recurrence or death by 76% in people with ALK positive resected ...