Cystic fibrosis life-altering drug nearing patient access across the country: Health Canada

20 June 2021 - For the cystic fibrosis community, persistence and constant belief are paying off. ...

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Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in people ages 12 and older who have at least one F508del mutation

18 June 2021 - Approximately 1,100 F/MF patients now eligible for a CFTR modulator to treat the underlying cause of their ...

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Ultragenyx announces approval of Dojolvi (UX007/triheptanoin) in Canada for the treatment of long-chain fatty acid oxidation disorders in adults and children

17 February 2021 - First approved treatment for adult and paediatric patients with long-chain fatty acid oxidation disorders in Canada. ...

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Vertex announces new drug submission for investigational triple combination medicine for the treatment of cystic fibrosis has been accepted for priority review by Health Canada

28 December 2020 - Vertex Pharmaceuticals Incorporated today announced its New Drug Submission for Trikafta, Vertex’s investigational triple combination medicine, ...

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Cystic Fibrosis Canada says 'life-changing' drug coming to Canada, but approval months away

11 November 2020 - The drug's manufacturer says it's moving forward with its cystic fibrosis medicines in Canada. ...

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Health Canada approves Maviret 8 week treatment duration for treatment naïve patients with genotype 3 compensated cirrhosis

10 November 2020 - Maviret (glecaprevir/pibrentasvir) is the only 8 week oral treatment approved for all hepatitis C virus genotypes. ...

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Knight and TherapeuticsMD announce Health Canada approval of Bijuva

21 September 2020 -  Knight Therapeutics and TherapeuticsMD announced today the approval of Bijuva (estradiol and progesterone) capsules by Health ...

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Health Canada issues notice of compliance for Bausch Health's Duobrii

11 June 2020 - Topical combination improving the sings and symptoms of plaque psoriasis in adult patients with moderate to ...

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Mithra and Searchlight Pharma announce filing of new drug submission for Estelle in Canada

20 May 2020 - Searchlight Pharma's new drug submission for a novel combined oral contraceptive accepted for review by Health Canada. ...

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Gilead Canada submits supplemental new drug submission to Health Canada for Descovy for HIV pre-exposure prophylaxis

9 April 2020 - Submission supported by data from the DISCOVER trial, which evaluated the safety and efficacy of Descovy compared ...

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Janssen announces Health Canada approval of Cabenuva, the first long-acting regimen for the treatment of HIV

20 March 2020 - Cabenuva offers adults living with HIV a new once-monthly injectable option for maintaining viral suppression. ...

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Nuvo Pharmaceuticals announces Health Canada approves Suvexx for the acute treatment of migraine

27 February 2020 - Canadian launch anticipated in the second half of 2020. ...

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Health Canada grants priority review status for Heron Therapeutics' new drug submission for HTX-011 for management of post-operative pain

3 December 2019 - Heron Therapeutics today announced that Heron's new drug submission for HTX-011 for the management of postoperative pain ...

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Health Canada approves Lonsurf (trifluridine/tipiracil) for adults with metastatic gastric cancer during stomach cancer awareness month

21 November 2019 - New indication improves overall survival for end stage metastatic disease ...

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Knight Therapeutics and SIFI announce approval of Netildex in Canada

23 October 2019 - Knight Therapeutics and SIFI today announced that Health Canada has approved Netildex for the treatment of inflammatory ...

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