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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Biocon Biologics receives Health Canada spproval for Yesintek and Yesintek I.V. (ustekinumab), a biosimilar to Stelara

23 October 2025 -  Biocon Biologics today announced that Health Canada has granted a notice of compliance for Yesintek (ustekinumab ...

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Apotex receives Health Canada approval for Loqtorzi - the first and only immuno-therapy for recurrent unresectable or metastatic nasopharyngeal cancer

23 October 2025 - Apotex today announced that Health Canada has granted a notice of compliance for Loqtorzi (toripalimab) 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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Health Canada approves Bylvay (odevixibat) for the treatment of cholestatic pruritus in patients with Alagille syndrome

9 Settember 2025 - Bylvay is the first and only medication approved in Canada for the treatment of both Alagille ...

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