Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis aged 2 years and older with certain rare mutations

15 July 2024 - Approximately 200 people with certain rare CF mutations are now eligible for Trikafta. ...

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Health Canada approves Tagrisso with the addition of chemotherapy for patients with EGFR mutated advanced lung cancer

12 July 2024 - Approval based on FLAURA2 results, which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...

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Health Canada authorises Rybrevant (amivantamab) in combination with carboplatin and pemetrexed as the only targeted first-line treatment approved for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations

3 July 2024 - Phase 3 PAPILLON study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival, ...

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Kye Pharmaceuticals announces the availability of Quillivant ER chewable tablets for the treatment of children with ADHD

2 July 2024 - Quillivant ER chewable tablets are the first and only extended release chewable methylphenidate tablets approved in Canada. ...

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Novavax submits application to Health Canada for updated protein-based 2024-2025 formula COVID-19 vaccine

2 July 2024 - Novavax's filing is aligned with NACI, US. FDA, EMA and WHO recommendations on vaccine composition. ...

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Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older

25 June 2024 - Patients treated with Ebglyss experienced significant skin clearance and itch relief as early as 4 weeks. ...

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Valneva announces Health Canada approval of the world’s first chikungunya vaccine, Ixchiq

24 June 2024 - Valneva today announced that Health Canada has approved Ixchiq, Valneva’s single-dose vaccine for the prevention of ...

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Takeda's HyQvia approved as replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in paediatric patients 2 years of age and older

21 June 2024 - Takeda Canada is pleased to announce that Health Canada has expanded the marketing authorisation for HyQvia (normal ...

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Awiqli - world's first once-weekly basal insulin - now available in Canada

17 June 2024 - Novo Nordisk is pleased to announce Canada will be the first country worldwide to launch Awiqli (insulin ...

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Adtralza (tralokinumab) pre-filled pen now available in Canada

12 June 2024 - The single-use 2 mL pre-filled pen is an additional injection choice for administering Adtralza for the ...

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Pfizer announces availability of Abrysvo in Canada for immunisation of pregnant individuals and adults 60+

22 May 2024 - Availability of Arbysvo is a major step in protecting infants and adults 60 years of age ...

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Health Canada approves Cosentyx, a biologic therapy, for the treatment of adults with moderate to severe hidradenitis suppurativa

22 May 2024 - Approval is based on the two largest Phase 3 trials conducted in hidradenitis suppurativa – SUNSHINE and SUNRISE ...

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Health Canada approves Saladax’s 5-fluorouracil chemotherapy therapeutic drug monitoring test

14 May 2024 - Saladax Biomedical is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale ...

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ViiV Healthcare announces Health Canada approval for Apretude (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV

13 May 2024 - The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a ...

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Health Canada approves Keytruda for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy

9 May 2024 - Approval is based on the Phase 3 KEYNOTE-966 Trial. ...

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