Shire reports regulatory milestones for investigational hereditary angioedema treatment lanadelumab

29 March 2018 - Filings are supported by data from HELP, the pivotal Phase 3 efficacy and safety study. ...

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Valeant Canada announces Health Canada approval of Contrave extended-release tablets for chronic weight management in adults

26 March 2018 - Valeant Canada today announced that Health Canada has approved Contrave extended-release tablets for use as an adjunct ...

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Health Canada accepts Cardiome's Xydalba new drug submission and grants priority review

22 March 2018 - Approval decision expected in third quarter 2018. ...

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Health Canada approves Rituxan subcutaneous formulation for Canadians with chronic lymphocytic leukaemia

22 March 2018 - Rituxan SC is a new treatment option for Canadians living with one of the most common forms ...

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BMS withdraws submission for Opdivo for urothelial carcinoma

20 March 2018 - Health Canada's handling of the submission is perplexing. ...

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Ipsen announces Health Canada approval of Dysport Therapeutic (abobotulinumtoxinA) for the treatment of lower limb spasticity in adults

15 March 2018 - With this approval, Dysport Therapeutic now has the broadest label of all approved botulinum neurotoxins for spasticity, ...

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Valeant receives Health Canada approval of Siliq (brodalumab) for moderate-to-severe plaque psoriasis

14 March 2018 - Valeant Canada announced that Health Canada granted on 6 March the Notice of Compliance for Siliq (brodalumab) ...

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Trumenba (meningococcal Group B vaccine) now available in Canada

6 March 2018 - Trumenba is the only vaccine indicated for adolescents and young adults aged 18 to 25 to prevent ...

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Health Canada approves Lonsurf (trifluridine/tipiracil) for metastatic colorectal cancer

6 March 2018 - Lonsurf, a new important treatment option for adult patients with metastatic colorectal cancer that has been shown ...

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Health Canada has approved Fasenra (benralizumab injection) for patients with severe eosinophilic asthma

26 February 2018 - AstraZeneca Canada today announced that Health Canada has approved Fasenra (benralizumab injection) as an add-on maintenance treatment ...

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Health Canada approves Bavencio (avelumab for injection) for the treatment of metastatic Merkel cell carcinoma in previously treated adult patients

22 February 2018 - First Health Canada approved treatment for rare and aggressive type of skin cancer. ...

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Health Canada approves new indication for Zytiga (abiraterone acetate), broadening its use for treatment of newly diagnosed metastatic prostate cancer

15 February 2018 - Zytiga, used in combination with prednisone and androgen deprivation therapy, was shown to reduce the risk ...

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Health Canada approves Ocrevus (ocrelizumab) for Canadians living with primary progressive multiple sclerosis

15 February 2018 - Ocrevus is a new treatment for a rare and worsening form of MS that impacts 10-15% ...

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Health Canada approves Ipsen's Somatuline Autogel for the treatment of carcinoid syndrome in adult patients with neuroendocrine tumours

13 February 2018 - Somatuline Autogel is the first and only somatostatin analog approved in Canada to treat enteropancreatic neuroendocrine ...

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Tagrisso (osimertinib) receives full Health Canada approval for targeted treatment of non-small-cell lung cancer

31 January 2018 - Approval based on Phase III AURA3 trial that demonstrated significant improvement in progression-free survival with Tagrisso compared ...

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