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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Henlius trastuzumab receives approval in Canada

22 August 2024 - Shanghai Henlius Biotech announced that the company's business partner, Accord Healthcare has received marketing approval (Notice of ...

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Health Canada approves Keytruda for the treatment of adult patients with unresectable locally advanced or metastatic urothelial cancer with no prior systemic therapy for metastatic urothelial cancer, in combination with enfortumab vedotin

22 August 2024 - Approval is based on the Phase 3 KEYNOTE-A39 trial. ...

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Lupin receives Health Canada approval for biosimilar pegfilgrastim

23 August 2024 - Lupin today announced that it has received approval from Health Canada for its biosimilar Pegfilgrastim.  ...

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Health Canada approves Celltrion’s Steqeyma, a biosimilar to Stelara (ustekinumab) for the treatment of multiple chronic inflammatory conditions

1 August 2024 - Steqeyma, is now approved in Canada for adult patients with plaque psoriasis as well as adults with ...

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Health Canada authorizes Vabysmo (faricimab injection) for the treatment of macular oedema secondary to retinal vein occlusion

29 July 2024 - This is the third indication for Vabysmo, in addition to neovascular or 'wet' age-related macular degeneration and ...

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