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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FDA faster than global peers at approving new drugs

16 May 2018 - A report from the Centre for Innovation in Regulatory Science released this month finds that the ...

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Incorporating the patient experience into regulatory decision making in the USA, Europe, and Canada

26 April 2018 - The clinical development of cancer therapeutics is a global undertaking, and incorporation of the patient experience into ...

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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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Akcea and Ionis announce acceptance of marketing applications in US, EU and Canada for volanesorsen for the treatment of FCS

15 November 2017 - FDA Prescription Drug User Fee Act goal date set for 30 August 2018. ...

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Workshop: addressing unmet needs of children with pulmonary arterial hypertension

6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...

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