Health Canada accepts for review new drug submission for tofersen for treatment of rare, genetic form of ALS

19 March 2024 - Health Canada regulatory decision on tofersen new drug submission expected in early 2025. ...

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Health Canada approves Pfizer Canada's gene therapy in haemophilia B

3 January 2024 - Pfizer Canada announced that Health Canada approved Beqvez (fidanacogene elaparvovec), an adeno-associated viral vector-based gene therapy for ...

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Health Canada authorises CSL's Hemgenix (etranacogene dezaparvovec) as first gene therapy for haemophilia B

26 October 2023 - CSL's Hemgenix is a one time, single dose treatment for adults with haemophilia B who require ...

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Health Canada approves Zolgensma, the one-time gene therapy for paediatric patients with spinal muscular atrophy

16 December 2020 - Zolgensma is designed to address the genetic root cause of SMA by replacing the missing or defective ...

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Health Canada approves first-ever gene replacement therapy, Luxturna

15 October 2020 - Luxturna (voretigene neparvovec), is the first approved therapy for previously untreatable inherited retinal disease. ...

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Alnylam launches Onpattro (patisiran) for the treatment of polyneuropathy in hATTR amyloidosis, the first-ever RNAi therapeutic approved in Canada

23 July 2019 - Onpattro is the only treatment that demonstrated improvement, relative to baseline, in both polyneuropathy and quality ...

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Akcea and Ionis announce approval of Tegsedi (inotersen injection) in Canada

4 October 2018 - First and only treatment of its kind for Canadians with hereditary transthyretin-mediated amyloidosis with polyneuropathy – a ...

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Alnylam Pharmaceuticals receives priority review in Canada for patisiran, an investigational RNAi therapeutic for the treatment of hereditary transthyretin-mediated amyloidosis with polyneuropathy

24 September 2018 - Health Canada grants priority review to promising medicines intended for the treatment of serious, debilitating or life-threatening ...

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Biogen's Spinraza (nusinersen) receives Notice of Compliance from Health Canada for the treatment of 5q spinal muscular atrophy

4 July 2017 - First SMA treatment approval in Canada. ...

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