Health Canada approves Tevimbra (tislelizumab for injection) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma

23 December 2025 - Approval supported by results of the RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival ...

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Knight Therapeutics announces Health Canada approval for Wynzora to treat psoriasis vulgaris

18 December 2025 - Knight Therapeutics announced today that Health Canada has approved Wynzora, a white uniform cream containing 0.05 ...

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Health Canada authorises TNKase (tenecteplase) for the treatment of acute ischaemic stroke

17 December 2025 - The approval marks the first new stroke treatment authorised in nearly 27 years, offering an additional ...

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Alnylam announces Health Canada approval of Amvuttra (vutrisiran), the first and only RNAi therapeutic for the treatment of cardiomyopathy in adult patients with ATTR amyloidosis

16 December 2025 - Alnylam Canada is pleased to announce that Health Canada has issued a Notice of Compliance authorising Amvuttra ...

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Chiesi Global Rare Diseases announces Health Canada approval of Elfabrio (pegunigalsidase alfa) for Fabry disease

16 December 2025 - Chiesi Global Rare Diseases today announced the Health Canada approval of Elfabrio (pegunigalsidase alfa) for the treatment ...

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Wegovy (semaglutide injection) receives conditional marketing authorisation from Health Canada as the first and only treatment for adults with non-cirrhotic MASH, a serious liver disease

15 December 2025 - Novo Nordisk announced today that Health Canada has issued marketing authorisation with conditions (Notice of Compliance ...

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PTC Therapeutics announces Health Canada approval of Sephience (sepiapterin) for the treatment of children and adults living with phenylketonuria

10 December 2025 - PTC Therapeutics Canada announced that Health Canada has approved Sephience (sepiapterin) for the treatment of children and ...

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Biogen receives Health Canada authorisation for Zurzuvae (zuranolone), the first and only treatment indicated for adults with postpartum depression in Canada

9 December 2025 - Biogen Canada today announced that Health Canada has issued a Notice of Compliance for Zurzuvae (zuranolone) ...

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Anzupgo (delgocitinib cream) now available in Canada for adult patients living with moderate to severe chronic hand eczema

2 December 2025 - Leo Pharma is pleased to announce the availability of Anzupgo (delgocitinib cream) across Canada for adults ...

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Celltrion receives Health Canada approval for Eydenzelt, a biosimilar referencing Eylea (aflibercept 2 mg)

27 November 2025 - The approval is based on the totality of evidence, including analytical, nonclinical, and clinical data from global ...

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Esperion partner HLS Therapeutics announces approval of Nilemdo for the reduction of LDL-cholesterol in Canadians at risk of cardiovascular disease

18 November 2025 -  Esperion today announced that HLS Therapeutics, the Company’s partner in Canada for the development and commercialization ...

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Lupron Depot new strength receives Health Canada approval for the treatment of advanced prostate cancer

17 November 2025 - AbbVie announced today that a new 6 month 45 mg Lupron Depot (leuprolide acetate for extended release ...

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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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