New treatment option now available in Canada for newly diagnosed patients with advanced lung cancer

18 March 2019 - Keytruda (pembrolizumab) in combination with pemetrexed and platinum chemotherapy reduced the risk of death by half compared ...

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Health Canada begins release of clinical data on drugs and devices

14 March 2019 - Health Canada launched two public databases on Wednesday as the first step in making clinical information ...

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Foquest receives approval for expanded indication for children and adolescents with ADHD

12 March 2019 - First and only methylphenidate product approved in Canada that provides control of ADHD symptoms throughout the day. ...

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Imbruvica (ibrutinib) combination regimen to treat Waldenström's macroglobulinemia approved through Health Canada priority review

8 March 2019 - Imbruvica plus rituximab showed significant improvement in progression-free survival versus rituximab monotherapy in Waldenström's macroglobulinemia, a ...

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Recordati Rare Diseases Canada announces Health Canada approval of Cystadrops (cysteamine ophthalmic solution) for cystinosis patients

4 March 2019 - Recordati Rare Diseases Canada today announced the approval of Cystadrops, the first cysteamine solution approved by Health ...

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Health Canada and CADTH launch new initiative to provide early parallel scientific advice

1 March 2019 - CADTH is pleased to announce a new collaboration with Health Canada and the Institut national d'excellence en ...

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Patient access to cost-effective treatments increased with launch of new biosimilar in Canada

28 February 2019 - First-ever pegfilgrastim biosimilar approved by Health Canada launches across the country. ...

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Health Canada approves Otsuka and Lundbeck's Rexulti (brexpiprazole) as adjunctive treatment of major depressive disorder

22 February 2019 - Otsuka and Lundbeck announce that Health Canada issued a Notice of Compliance for Rexulti (brexpiprazole) for ...

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Paladin Labs announces approval of Envarsus PA (tacrolimus prolonged-release tablets) in Canada

22 February 2019 - Paladin Labs and Endo today announced Health Canada's approval of Envarsus PA (tacrolimus prolonged-release tablets) for ...

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AbbVie's Humira (adalimumab) approved by Health Canada to treat paediatric patients with chronic non-infectious anterior uveitis

20 February 2019 - The approval marks Humira as the only approved biologic treatment option in Canada for paediatric patients from ...

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Diverging from FDA, Health Canada announces suffix-free biologic and biosimilar naming convention

18 February 2019 - Health Canada has announced that all biologics, including biosimilars, will be identified by their brand names and ...

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Gilead receives approval in Canada for Yescarta (axicabtagene ciloleucel) CAR T therapy for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy

19 February 2019 - Yescarta is a chimeric antigen receptor T-cell therapy that is custom-made for each patient from his or ...

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Health Canada issues Notice of Compliance with Conditions for Idhifa the first oral targeted therapy for adult patients with relapsed or refractory acute myeloid leukaemia and an IDH2 mutation

11 February 2019 - Conditional approval validates Idhifa as the first and only oral, targeted inhibitor of IDH2. ...

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Advanced Accelerator Applications announces Health Canada approval for Lutathera, a treatment for gastro-enteropancreatic neuroendocrine tumours

7 February 2019 - First ever approved peptide receptor radionuclide therapy in Canada. ...

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Health Canada grants market authorisation for Kalydeco (ivacaftor) in children ages 12 to <24 months with certain mutations in the CFTR gene

28 January 2019 - Kalydeco is the first and only approved medicine in Canada to treat the underlying cause of ...

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