Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in people ages 12 and older who have at least one F508del mutation

18 June 2021 - Approximately 1,100 F/MF patients now eligible for a CFTR modulator to treat the underlying cause of their ...

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Dupixent (dupilumab) pre-filled pen now available in Canada, providing convenient self-administration option for people with type 2 inflammatory diseases

17 June 2021 - The pre-filled pen offers an additional administration option for all Dupixent indications in patients aged 12 years ...

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Amylyx Pharmaceuticals files new drug submission for AMX0035 for the treatment of ALS in Canada

14 June 2021 - Submission supported by data from the CENTAUR trial. ...

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Controversial Alzheimer’s drug approved in U.S. Where does Canada stand?

10 June 2021 - The Alzheimer Society of Canada welcomed the new treatment urging Canadian health authorities to complete its required ...

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Health Canada grants interim order authorisation for casirivimab and imdevimab for the treatment of mild to moderate COVID-19

10 June 2021 - Interim data shows treatment with casirivimab and imdevimab resulted in a statistically significant reduction in viral ...

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Paladin Labs announces approval of Wakix (pitolisant) in Canada

9 June 2021 - Paladin Labs today announced Health Canada's approval of Wakix (pitolisant) for the treatment of excessive daytime sleepiness ...

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Moderna files for authorisation with Health Canada for its COVID-19 vaccine in adolescents

7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...

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Health Canada approves AbbVie's Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis

7 June 2021 - Approval supported by efficacy and safety data of two pivotal Phase 3 trials in which Rinvoq demonstrated ...

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After repeated losses in the U.S., Catalyst wins a victory in Canada over a rare disease drug

3 June 2021 - In an unexpected move, Canada’s Federal Court quashed the approval of a rare disease drug after ...

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Health Canada accepts new drug submission for Reduvo as a treatment for patients with chemotherapy-induced nausea and vomiting

2 June 2021 - Tetra Bio-Pharma announced today that Health Canada has accepted its new drug submission for Reduvo and has ...

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Health Canada approves Opdivo (nivolumab) plus Yervoy (ipilimumab) as the first and only immunotherapy treatment for previously untreated unresectable malignant pleural mesothelioma

2 June 2021 - First new systemic therapy in more than 15 years for cancer related to asbestos exposure. ...

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Health Canada approves Abecma (idecabtagene vicleucel), the first and only anti-BCMA CAR T cell therapy for relapsed and refractory multiple myeloma

31 May 2021 - Abecma is the first personalised cell therapy available to Canadian patients for the treatment of adults ...

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Canada's change to Pfizer vaccine storage temperature has major implications on rollout

19 May 2021 - Health Canada now recommends storing Pfizer vaccine at fridge temperatures for up to 1 month. ...

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Health Canada issues Notice of Compliance for Bausch Health's Bryhali

5 May 2021 - Bausch Health Canada today announced that Health Canada has approved the use of Bryhali (halobetasol propionate 0.01% ...

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Health Canada authorises use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 years of age

5 May 2021 - Today, Health Canada authorised the use of the Pfizer-BioNTech COVID-19 vaccine in children 12 to 15 ...

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