Kye Pharmaceuticals announces the approval of Dynavel XR (amphetamine extended release) tablets and oral suspension for the treatment of adults and children with ADHD

5 August 2025 - Kye Pharmaceuticals is pleased to announce the Health Canada approval (notice of compliance) for Dyanavel XR ...

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Health Canada expands approval of Scemblix, making it an option for newly diagnosed and previously treated chronic myeloid leukaemia patients

30 July 2025 - Scemblix is first to show superior efficacy and a favourable safety and tolerability profile in a Phase ...

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CDA issues positive reimbursement recommendation for Skyclarys (omaveloxolone), the only Health Canada approved treatment for managing Friedreich ataxia

29 July 2025 - Biogen Canada is pleased to announce a significant step forward for Canadians living with Friedreich ataxia, ...

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Novartis and the pan-Canadian Pharmaceutical Alliance achieve milestone agreement on Cosentyx for hidradenitis suppurativa (

23 July 2025 - Following this important milestone, Cosentyx has been listed in Québec. ...

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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 ...

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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 ...

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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. ...

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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) ...

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Bavarian Nordic receives acceptance from Health Canada for review of the new drug submission for its chikungunya vaccine

22 July 2025 -  Bavarian Nordic announced today that Health Canada has accepted for review the Company’s application for licensure ...

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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 ...

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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 ...

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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 ...

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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 ...

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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, ...

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Quebec implements public reimbursement of Pluvicto - a defining milestone for radioligand therapy in Canada

3 July 2025 - Pluvicto now publicly funded in provinces covering most Canadians, offering renewed hope to those facing progressive PSMA ...

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