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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 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 ...
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 13 Jul 2024
Health Canada approves Tagrisso with the addition of chemotherapy for patients with EGFR mutated advanced lung cancer
12 July 2024 - Approval based on FLAURA2 results, which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 04 Jul 2024
Health Canada authorises Rybrevant (amivantamab) in combination with carboplatin and pemetrexed as the only targeted first-line treatment approved for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations
3 July 2024 - Phase 3 PAPILLON study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival, ...
Posted by Michael Wonder on 26 Jun 2024
Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older
25 June 2024 - Patients treated with Ebglyss experienced significant skin clearance and itch relief as early as 4 weeks. ...
Posted by Michael Wonder on 25 Jun 2024
Valneva announces Health Canada approval of the world’s first chikungunya vaccine, Ixchiq
24 June 2024 - Valneva today announced that Health Canada has approved Ixchiq, Valneva’s single-dose vaccine for the prevention of ...
Posted by Michael Wonder on 22 Jun 2024
Takeda's HyQvia approved as replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in paediatric patients 2 years of age and older
21 June 2024 - Takeda Canada is pleased to announce that Health Canada has expanded the marketing authorisation for HyQvia (normal ...