Health Canada approves Xeomin (incobotulinumtoxinA) for treatment of adults with post-stroke lower limb spasticity in the ankle and foot

17 December 2024 - Merz Therapeutics today announced that Health Canada approved Xeomin (incobotulinumtoxinA) for the treatment of post-stroke lower limb ...

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Health Canada approves Celltrion’s Omlyclo (CT-P39), the first and only omalizumab biosimilar in Canada

9 December 2024 - Omlyclo (CT-P39) is the first and only omalizumab biosimilar referencing Xolair approved in Canada to treat multiple ...

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Veozah (fezolinetant film coated tablets) receives Health Canada approval as first and only non-hormonal treatment for vasomotor symptoms associated with menopause

3 December 2024 - New treatment option helps fill unmet need for women experiencing hot flashes and night sweats associated ...

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Health Canada approves Wegovy (semaglutide injection) to reduce the risk of non-fatal myocardial infarction

27 November 2024 - Wegovy is the first and only medication indicated for both chronic weight management and to reduce the ...

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Health Canada authorises Carvykti (ciltacabtagene autoleucel) for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy

21 November 2024 - Authorisation is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with ...

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Knight Therapeutics announces Health Canada approval for Jornay PM to treat attention deficit hyperactivity disorder

14 November 2024 - Knight Therapeutics announced today that Health Canada has approved Jornay PM, an extended-release formulation of methylphenidate, a ...

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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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Moderna receives Health Canada approval for RSV vaccine for adults aged 60 years and older

8 November 2024 - mRESVIA is Moderna's second approved product in Canada, the first mRNA vaccine against RSV, and the only ...

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Expanded age indication for GSK's Arexvy, the first respiratory syncytial virus vaccine approved in Canada for adults aged 50-59 at increased risk

5 November 2024 - Clinical development program continues to evaluate safety and immunogenicity in adults aged 18-49 at increased risk ...

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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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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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Health Canada approves label expansion for Telix’s Illuccix to include patient selection for PSMA targeted therapy

4 October 2024 - Telix Pharmaceuticals today announces that Health Canada has approved the use of Illuccix (kit for the ...

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Health Canada grants marketing authorisation of first CRISPR/Cas9 gene edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia

25 September 2024 - First regulatory authorisation of a CRISPR-based gene-editing therapy in Canada. ...

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