Arcutis Canada announces Health Canada approval of Zorvye 0.3% topical foam, the first steroid-free topical foam for scalp and body psoriasis, for adults and adolescents ages 12 and older

13 November 2025 - Approval supported by pivotal Phase 3 and Phase 2 data demonstrating rapid improvement in skin clearance and ...

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Marius Pharmaceuticals expands global footprint with Health Canada approval of Kyzatrex (testosterone undecanoate) CIII capsules

12 November 2025 - Marius Pharmaceuticals today announced that Health Canada has approved Kyzatrex (testosterone undecanoate) CIII capsules.  ...

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argenx announces Vvygart SC pre-filled syringe for self-Injection in chronic inflammatory demyelinating polyneuropathy authorised for sale by Health Canada

5 November 2025 - argenx today announced that Health Canada has issued a Notice of Compliance authorising Vvyvart SC (efgartigimod alfa ...

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Enhertu approved in Canada as the first and only HER2 directed therapy for patients with HR positive HER2 low or HER2 ultra low metastatic breast cancer, following disease progression after one or more endocrine therapies

29 October 2025 - Based on the DESTINY-Breast06 Phase 3 trial results demonstrating statistically significant and clinically meaningful progression-free survival ...

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Health Canada grants authorisation for Leqembi (lecanemab) for the treatment of early Alzheimer’s disease

26 October 2025 - Eisai and Biogen announced today that Health Canada has issued a notice of compliance with conditions for ...

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Dupixent (dupilumab injection) approved in Canada for adults with inadequately controlled chronic obstructive pulmonary disease

22 October 2025 - Health Canada has approved Dupixent (dupilumab injection) as an add-on maintenance treatment in adult patients with chronic ...

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Lyvdelzi (seladelpar) receives Health Canada approval for the treatment of primary biliary cholangitis

21 October 2025 - Gilead Sciences today announced that Health Canada has approved Lyvdelzi (seladelpar) for the treatment of primary biliary ...

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Pfizer Canada announces Health Canada approval of Abrysvo for adults 18+

21 October 2025 - With the approval of Arbysvo for adults aged 18+, there is now a way to help ...

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Incyte Canada announces Health Canada approval of Opzelura (ruxolitinib) cream for the treatment of atopic dermatitis in children ages 2-11

15 October 2025 - First and only topical JAK inhibitor cream approved in Canada for paediatric atopic dermatitis. ...

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Jesse's dad, who walked Canada for his son, cheers approval of new Duchenne drug

3 October 2025 - Vamorolone is the first Health Canada approved drug developed specifically to treat Duchenne. ...

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Health Canada approves Agamree (vamorolone) as the first treatment for Duchenne muscular dystrophy in Canada

2 October 2025 - Kye Pharmaceuticals announced today that Health Canada has approved Agamree (vamorolone) for the treatment of Duchenne muscular ...

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Organon Canada announces the availability of Nduvra (1% tapinarof cream) for the topical treatment of plaque psoriasis in adults

1 October 2025 - Organon Canada announces the availability of Ndruvra (1% tapinarof cream) for the topical treatment of plaque psoriasis ...

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Teva and Medincell’s risperidone LAI approved in Canada as Longavo

23 September 2025 - Teva Canada has received regulatory approval for risperidone long-acting injection from Health Canada for the treatment ...

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Health Canada approves Celltrion’s Stoboclo and Osenvelt (CT-P41), denosumab biosimilars for the treatment of all indications approved for the reference products, Prolia and Xgeva, respectively

18 September 2025 - The approval is based on the totality of evidence including results from a Phase III clinical ...

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Health Canada approves Slenyto - extended-release melatonin formulation - as a prescription drug for insomnia in children with autism spectrum disorder and Smith-Magenis syndrome

10 September 2025 - Neurim Pharmaceuticals is pleased to announce that Health Canada has granted marketing authorisation for Slenyto, an ...

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