Health Canada authorises Verzenio (abemaciclib) as the first and only CDK4/6 inhibitor for patients with HR+ HER2- high risk early breast cancer

27 January 2022 - Adding Verzenio to endocrine therapy demonstrated a significant and clinically meaningful reduction in the risk of recurrence ...

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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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Emergent BioSolutions receives Health Canada approval of BioThrax (anthrax vaccine adsorbed)

17 December 2018 - Emergent BioSolutions today announced that Health Canada has approved the company’s new drug submission for its anthrax ...

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Health Canada approves Darzalex (daratumumab) for newly diagnosed patients with multiple myeloma who are transplant ineligible

17 December 2018 - Darzalex combination therapy significantly reduced the risk of disease progression or death compared to a preferred regimen ...

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Alimera Sciences announces Canadian regulatory approval for Iluvien

26 November 2018 - Alimera Sciences today announced that Health Canada has approved Iluvien for the treatment of diabetic macular oedema.  ...

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Health Canada has now authorised Adynovate [anti-haemophilic factor (recombinant), PEGylated] in paediatrics for treatment of children under 12 with haemophilia A

26 November 2018 - Canadian children now have access to Adynovate, which offers a twice-weekly prophylaxis dosing schedule and on-demand control ...

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Indivior announces Health Canada approval of Sublocade (buprenorphine extended release) injection for patients with moderate to severe opioid use disorder

23 November 2018 - Sublocade is the first and only once-monthly injectable buprenorphine formulation approved in Canada for the management of ...

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Health Canada offers HTA aligned reviews for drugs and biologics

25 June 2018 - Sponsors of biologics and new drug submissions now have the option of requesting aligned regulatory reviews ...

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