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RSS FeedPosted 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 13 Aug 2024
Introducing Jubbonti and Wyost, the first denosumab biosimilars on the Canadian market
12 August 2024 - Jubbonti and Wyost are first denosumab biosimilars available in Canada, reflecting the Sandoz Purpose of pioneering access ...
Posted by Michael Wonder on 02 Aug 2024
Marius Pharmaceuticals submits Kyzatrex (testosterone undecanoate) capsules for approval to Health Canada
30 July 2024 - Marius Pharmaceuticals is pleased to announce the submission of its new drug submission for Kyzatrex (testosterone ...
Posted by Michael Wonder on 02 Aug 2024
Nordimet (methotrexate) self-injection pen now available in Canada for treatment of rheumatoid arthritis and psoriasis/psoriatic arthritis
1 August 2024 - Linepharma is pleased to announce that Nordimet (methotrexate), the first methotrexate single-use pre-filled pen for self-injection, ...
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 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 25 Jul 2024
Kye Pharmaceuticals secures exclusive license, supply and commercialisation agreement with Catalyst Pharmaceuticals for Agamree, a novel treatment for Duchenne muscular dystrophy, in Canada
24 July 2024 - Kye Pharmaceuticals today announced that it has entered into a license, supply and commercialisation agreement with Catalyst ...
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 ...
Posted by Michael Wonder on 16 Jul 2024
Doug Ford wants Canada to approve drugs faster. Is that possible?
15 July 2024 - Talk of the delay in drugs is top of mind for Ford, who arrived in Nova Scotia ...