Bimzelz (bimekizumab injection) approved in Canada for treatment of moderate to severe hidradenitis suppurativa

13 January 2026 - The approval is based on clinically significant results from UCB's two pivotal Phase 3 trials demonstrating ...

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Health Canada approves Rybelsus (semaglutide tablets) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes

12 January 2026 - The indication expansion is based on positive outcomes observed in the cardiovascular outcomes (SOUL) trial data, ...

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Galderma announces the authorisation of Nemluvio (nemolizumab) for atopic dermatitis and prurigo nodularis in Canada

12 January 2026 - Nemluvio is now authorised for sale by Health Canada based on results from the Phase III ARCADIA ...

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Maviret receives Health Canada approval for the treatment of acute hepatitis C virus

6 January 2026 - Maviret received approval through Health Canada's priority review process, based on data from the Phase 3 M20-350 ...

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Idorsia’s Jeraygo (aprocitentan) approved in Canada for the treatment of resistant hypertension

5 January 2026 - Idorsia announces that Health Canada has granted marketing authorisation for Jeraygo (aprocitentan) for the treatment of resistant ...

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Arrowhead Pharmaceuticals announces Health Canada approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome

5 January 2026 - The Health Canada approval is based on positive results from the Phase 3 PALISADE study where Redemplo ...

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Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine

5 January 2026 - Moderna today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults ...

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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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