Is Canada missing out? An assessment of drugs approved internationally between 2016 and 2020 and not submitted for Health Canada review

12 June 2023 - One-third of the new active substances approved in the United States and Europe between 2016 and ...

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Health Canada’s position on the CADTH guidance for reporting RWE to support decision-making

18 May 2023 - Canada’s CADTH collaborated with Health Canada and other stakeholders to develop the guidance for reporting real world ...

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Medunik Canada obtains new Notice of Compliance from Health Canada for Ruzurgi (amifampridine) following a favourable Canadian Federal Court of Appeal ruling

17 January 2023 - Medunik Canada is pleased to announce that on 9 January 2023, the Federal Court of Appeal of ...

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Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency

16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...

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Health Canada authorises Vabysmo (faricimab injection) for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular oedema

1 June 2022 - Vabysmo (faricimab injection) is the first bispecific antibody that acts by neutralising both VEGF-A and Ang-2 ...

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Medicago, Philip Morris and Health Canada: a predictable and avoidable fiasco

22 March 2022 - Health groups urge the Federal government to pressure Medicago to align its approach with that of ...

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Catalyst Pharmaceuticals and KYE Pharmaceuticals announce a second favourable Canadian Federal Court ruling setting aside approval of Ruzurgi

11 March 2022 - Catalyst Pharmaceuticals and KYE Pharmaceuticals today announced receipt of a favourable decision from the Federal Court of ...

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The Product Monograph for Protopic has been updated

4 October 2021 - LEO Pharma Inc. today announced that Health Canada has approved an update to the Product Monograph of ...

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Optimising the data available via Health Canada’s clinical information portal

23 August 2021 - Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast ...

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In an about face, Health Canada allows a controversial rare disease drug back on the market

26 June 2021 - In yet another twist in a complicated tale, Health Canada has reinstated approval of a rare ...

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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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Statement from Health Canada on Janssen COVID-19 vaccines and Emergent BioSolutions

30 April 2021 - Health Canada continues to ensure the quality and safety of vaccines coming into Canada by working ...

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Health Canada stands by approval of AstraZeneca, Johnson & Johnson COVID-19 vaccines

14 April 2021 - Health Canada is standing by the approval of the Oxford-AstraZeneca and Johnson & Johnson vaccines for ...

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Canada urges halt in use of AstraZeneca COVID-19 vaccine in people under 55

30 March 2021 - Canadian authorities recommended Monday a halt on administering the AstraZeneca PLC COVID-19 vaccine on people under ...

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EMA and Health Canada publish clinical data used to support their authorisations of the Moderna COVID-19 vaccine

2 March 2021 - Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada ...

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