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RSS FeedPosted by Michael Wonder on 27 Jul 2025
Vertex announces marketing authorisation in Canada for Alyftrek, a once daily next generation CFTR modulator for the treatment of cystic fibrosis
22 July 2025 - Approximately 3,800 people in Canada are now eligible for Alyftrek, with up to 60 people potentially ...
Posted by Michael Wonder on 26 Jul 2025
Health Canada grants marketing authorisation for Bayer’s Lynkuet (elinzanetant)
25 July 2025 - Authorisation is supported by data from the Phase 3 OASIS clinical trial program evaluating Lynkuet for the ...
Posted by Michael Wonder on 24 Jul 2025
Blenrep (belantamab mafodotin) combinations approved in Canada for the treatment of relapsed/refractory multiple myeloma
23 July 2025 - Superior efficacy shown in two head-to-head phase III trials, including overall survival in DREAMM-7. ...
Posted by Michael Wonder on 24 Jul 2025
Clearside Biomedical announces approval of Xipere suprachoroidal treatment for uveitic macular oedema in Canada
23 July 2025 - Clearside Biomedical announced today that Health Canada has granted approval for Xipere (triamcinolone acetonide injectable suspension) ...
Posted by Michael Wonder on 22 Jul 2025
Health Canada approves Keytruda for the treatment of adult patients with FIGO 2014 Stage III-IVA cervical cancer, in combination with chemoradiotherapy
21 July 2025 - Approval is based on the results from Phase 3 KEYNOTE-A18/ENGOT-cx11/GOG-30472 ...
Posted by Michael Wonder on 19 Jul 2025
Knight Therapeutics announces filing of new drug submission for Crexont (carbidopa and levodopa) extended release capsules in Canada
18 July 2025 - Knight Therapeutics announced today that Knight's new drug submission for Crexont has been accepted for review ...
Posted by Michael Wonder on 16 Jul 2025
Health Canada approves Lilly's Omvoh (mirikizumab) for Crohn's disease; new citrate-free formulation
15 July 2025 - Eli Lilly Canada announced today that Health Canada has approved Omvoh (mirikizumab) for Crohn's disease, which will ...
Posted by Michael Wonder on 15 Jul 2025
Health Canada extends the approval of Evkeeza (evinacumab) to children as young as 6 months old with homozygous familial hypercholesterolaemia
14 July 2025 - Ultragenyx today announced that Health Canada has extended the approval of Evkeeza (evinacumab) as an adjunct to ...
Posted by Michael Wonder on 11 Jul 2025
Zepbound KwikPen (tirzepatide), the first and only dual receptor agonist for the treatment of obesity, now approved and available in Canada
9 July 2025 - Eli Lilly Canada is pleased to announce that Zepbound KwikPen (tirzepatide injection) is now available in Canada, ...
Posted by Michael Wonder on 03 Jul 2025
Apotex receives Health Canada approval for Aflivu, a biosimilar to Eylea, available in pre-filled syringe and vial formats
2 July 2025 - Apotex today announced that Health Canada has approved Aflivu (aflibercept), a biosimilar to Eylea, indicated for ...
Posted by Michael Wonder on 28 Jun 2025
Biocon Biologics receives Health Canada approval for Yesafili (aflibercept); first global launch scheduled for July 2025
27 June 2025 - Biocon Biologics is pleased to announce that Health Canada has granted a Notice of Compliance for Yesafili ...
Posted by Michael Wonder on 27 Jun 2025
Xtandi (enzalutamide) now funded in Ontario for all approved prostate cancer indications
26 June 2025 - Today, Astellas Pharma Canada announced that Xtandi (enzalutamide) is now funded by the Ontario Drug Benefit Program ...
Posted by Michael Wonder on 19 Jun 2025
Kye Pharmaceuticals receives Health Canada approval for new dosing guidance for Firdapse and an additional paediatric indication
17 June 2025 - Kye Pharmaceuticals today announced that Health Canada has approved its supplemental new drug submission regarding the recommended ...
Posted by Michael Wonder on 19 Jun 2025
Health Canada approves Novartis' Kisqali for HR positive, HER2 negative early breast cancer patients at high risk of recurrence
18 June 2025 - Health Canada approval is based on the pivotal Phase 3 NATALEE trial data, which demonstrated a clinically ...
Posted by Michael Wonder on 17 Jun 2025
Vanflyta is now approved in Canada specifically for adult patients with newly diagnosed FLT3-ITD positive AML
16 June 2025 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival ...