Ojjaara (momelotinib) approved in Canada for the treatment of myelofibrosis in adults who have moderate to severe anaemia

12 November 2024 - Ojjaara (momelotinib) is the only approved treatment for newly diagnosed and previously treated myelofibrosis patients who have ...

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Health Canada approves first and only oral targeted treatment for brain cancer

22 October 2024 - Pivotal Phase 3 study shows significant improvement in progression-free survival with a favourable safety profile. ...

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Arcutis announces Health Canada approval of Zoryve (roflumilast) foam 0.3% to treat seborrheic dermatitis in individuals 9 years of age and older

18 October 2024 - Zoryve foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved ...

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Fresenius Kabi launches Tyenne, the first and only approved tocilizumab biosimilar in Canada

17 October 2024 - Tyenne is the first and only tocilizumab biosimilar to be launched in Canada. ...

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Incyte announces Health Canada approval of Opzelura (ruxolitinib) cream for the treatment of atopic dermatitis and non-segmental vitiligo

16 October 2024 - First and only treatment approved by Health Canada for repigmentation of non-segmental vitiligo. ...

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Acadia Pharmaceuticals announces Health Canada approval of Daybue (trofinetide) for the treatment of Rett syndrome

16 October 2024 - Daybue is the first and only therapy approved in Canada for the treatment of Rett syndrome, a ...

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Clinuvel files Canadian new drug submission for Scenesse in EPP

30 September 2024 - Patient special access program continues during Health Canada review. ...

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Vertex announces Health Canada acceptance of new drug submission for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis

26 September 2024 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review its new drug submission for ...

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Biogen's new drug submission for omaveloxolone accepted for priority review by Health Canada for the treatment of Friedreich's ataxia

17 September 2024 - If approved, omaveloxolone would be the only disease specific treatment option for patients living with this progressive ...

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Dupixent (dupilumab injection) approved in Canada for the treatment of children aged 1 year and older with eosinophilic oesophagitis

12 September 2024 - This is the ninth indication for Dupixent in Canada and its second in gastroenterology. ...

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Health Canada approves Keytruda as monotherapy for the treatment of adult and paediatric patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient solid tumours that have progressed following prior treatment and who have no satisfactory alternative treatment options

12 September 2024  - Merck announced that Health Canada has granted approval of Keytruda (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy ...

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Health Canada approves Cabtreo (clindamycin phosphate, adapalene and benzoyl peroxide) triple combination topical treatment for acne vulgaris in patients 12 years of age and older

11 September 2024 - Bausch Health today announced the approval by Health Canada of Cabtreo (clindamycin phosphate, adapalene and benzoyl ...

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Health Canada approves AbbVie's Constella (linaclotide) for the treatment of functional constipation in paediatric patients 6 to 17 years of age

10 September 2024 - Submission is based on positive Phase 3 study data demonstrating linaclotide (72 mcg) resulted in increases ...

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Winrevair (sotatercept) is now authorised for use in Canada for adults with pulmonary arterial hypertension

4 September 2024 - Merck announced that Winrevair (sotatercept) is now authorised for use in Canada in combination with standard ...

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Kye Pharmaceuticals announces approval in Canada for ACCRUFeR (ferric maltol) for the treatment of iron deficiency anaemia in adult patients

27 August 2024 - Kye Pharmaceuticals today announced that ACCRUFeR (ferric maltol) has received market authorisation as a prescription medicine in ...

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