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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Men get breast cancer, too. But they can't always access new drugs.

21 September 2024 - Breast cancer is widely researched, but some men suffering from the illness say they can’t benefit. ...

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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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BioCryst and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Orladeyo (berotralstat), an oral, once daily therapy for the prevention of hereditary angioedema attacks

17 September 2024 -  BioCryst Pharmaceuticals today announced that it successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance for oral, ...

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Abrysvo: Pfizer Canada's newly publicly funded vaccine a step towards national RSV prevention in older adults

19 September 2024 -  Today, Pfizer Canada announced that Abrysvo has been selected as the publicly funded vaccine for the ...

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Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada

18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...

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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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Merck Canada and the pan-Canadian Pharmaceutical Alliance successfully complete negotiations for Welireg (belzutifan)

5 September 2024 - Merck announced that it has successfully completed negotiations with the pan-Canadian Pharmaceutical Alliance for Welireg (belzutifan) on ...

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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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Today’s the day: we are officially Canada’s Drug Agency

5 September 2024 - We are expanding on our existing mandate and functions — which span drugs, medical devices, and clinical ...

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