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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Pfizer Canada and BioNTech receive Health Canada approval of Omicron KP.2 variant adapted COVID-19 vaccine

24 September 2024 - Omicron KP.2 variant adapted vaccine Comirnaty is now authorised in Canada for individuals 6 months of age ...

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Moderna receives Health Canada approval for updated COVID-19 vaccine targeting KP.2 variant of SARS-COV-2 for ages six months and older

17 September 2024 - Spikevax is the first updated COVID-19 vaccine authorised in Canada for 2024-2025, offering a timely solution to ...

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New COVID-19 vaccine by Moderna approved by Health Canada

17 September 2024 - Health Canada has approved an updated version of Moderna’s COVID-19 vaccine, a decision that means some ...

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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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Padcev (enfortumab vedotin) in combination with pembrolizumab approved by Health Canada to treat advanced bladder cancer

22 August 2024 - Padcev plus pembrolizumab approved based on EV-302 trial. ...

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