Health Canada approves Quviviq (daridorexant) for the management of adult patients with insomnia

3 May 2023 - Quviviq is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset ...

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Libtayo (cemiplimab) in combination with chemotherapy now approved in Canada for the first-line treatment of advanced non-small cell lung cancer

1 May 2023 - Approval marks second first-line indication in NSCLC and fifth indication for Libtayo in Canada. ...

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Arcutis announces Canadian approval of Zoryve (roflumilast) cream 0.3% for treatment of plaque psoriasis in individuals 12 years and older

28 April 2023 - First Zoryve approval outside of the US marks key milestone for Arcutis. ...

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Health Canada approves new antibody drug to help prevent serious RSV in babies

22 April 2023 - Health Canada has approved a new antibody drug to help protect babies from serious illness caused ...

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AbbVie announces provincial reimbursement for Vraylar (cariprazine) for the treatment of schizophrenia in Québec

17 April 2023 - AbbVie today announced that Vraylat is now listed as an exception medication status on the list of ...

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Health Canada approves Alhemo, the first subcutaneous prophylactic treatment for people living with haemophilia B with inhibitors

17 April 2023 - New treatment option for Canadians living with rare and serious X-chromosome linked congenital bleeding disorder ...

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Pfizer Canada initiates submission to Health Canada for its bivalent respiratory syncytial virus vaccine

14 April 2023 - Indications under review include prevention of respiratory syncytial virus in infants from birth through 6 months ...

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Vertex announces Health Canada market authorisation for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 1 to <2 years

10 April 2023 - With this approval, approximately 30 children with two copies of the F508del mutation are eligible for ...

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Koselugo approved in Canada for paediatric patients with neurofibromatosis type 1 plexiform neurofibromas

3 April 2023 - First and only therapy approved to treat this rare and debilitating genetic condition. ...

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Chiesi Global Rare Diseases announces approval of Ferriprox MR deferiprone extended release tablets in Canada

31 March 2023 - New formulation allows twice-daily dosing in patients with transfusional iron overload due to thalassaemia syndromes when ...

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Kite's Yescarta (axicabtagene ciloleucel) first CAR T-cell therapy to receive Health Canada authorisation for use in second-line large B-cell lymphoma

23 March 2023 - Landmark ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at ...

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Health Canada authorises Imbruvica (ibrutinib) in a fixed duration combination with venetoclax for adult patients with previously untreated chronic lymphocytic leukaemia

23 March 2023 - All oral, once daily, fixed duration combination regimen authorised for first-line treatment of CLL. ...

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Columvi (glofitamab for injection) receives Health Canada authorisation with conditions for adult patients with relapsed or refractory diffuse large B-cell lymphoma

25 March 2023 - Authorization is based on results from the Phase 1/2 NP30179 study, which demonstrated Columvi induced durable response ...

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Health Canada approves first treatment option for generalised pustular psoriasis flares in adults

24 March 2023 - In the EFFISAYIL-1 trial, over half of the Spevigo (spesolimab) treated patients were free of pustules, ...

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Samsung Bioepis launches Lucentis biosimilar in Canada, Germany

5 March 2023 - According to industry sources on Sunday, SB11 was introduced to the Canadian market last Wednesday through its ...

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