Viatris and Biocon Biologics launch Abevmy (bevacizumab), their third oncology siosimilar, in Canada

19 May 2022 - Viatris and Biocon Biologics announced today that Abevmy (bevacizumab) is now available in Canada.  ...

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Alnylam announces Health Canada authorisation of Oxlumo (lumasiran), the first and only treatment for primary hyperoxaluria type 1 to lower urinary oxalate levels in paediatric and adult patients

18 May 2022 - Authorization based on two pivotal Phase 3 trials, ILLUMINATE-A and ILLUMINATE-B; showing significant reduction in urinary ...

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Health Canada accepts SNDS filing and grants priority review of oral edarvarone formulation for the treatment of ALS

13 May 2022 - Mitsubishi Tanabe Pharma Canada announced today that Health Canada has accepted the filing of a supplement to ...

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Health Canada approves Ipsen's Cabometyx (cabozantinib) for patients with previously treated radioactive iodine refractory or ineligible differentiated thyroid cancer

Pivotal Phase 3 trial data showed Cabometyx demonstrated a significant improvement in progression-free survival. ...

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Moderna submits COVID-19 vaccine for kids 5 and under to Health Canada for review

29 April 2022 - Moderna has asked Health Canada to approve its COVID-19 vaccine for children as young as six ...

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Health Canada approves Vraylar (cariprazine) for the treatment of bipolar l disorder and schizophrenia in adults

27 April 2022 - Vraylar is a new atypical antipsychotic medication with partial agonist activity at central dopamine D3 receptors ...

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Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 years with at least one F508del mutation

20 April 2022 - Vertex has submitted this indication to CADTH & INESSS for health technology assessments. ...

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Otsuka announces Health Canada approval of Tavneos (avacopan) for ANCA associated vasculitis

20 April 2022 - Launch is expected in Canada in the fourth quarter of 2022. ...

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Health Canada approves Keytruda (pembrolizumab) for the treatment of adult patients with high risk early stage triple negative breast cancer in combination with chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery

18 April 2022 - Approval Based on Data from Phase 3 KEYNOTE-522 Trial ...

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Evusheld receives Health Canada approval for pre-exposure prophylaxis (prevention) of COVID-19 in immune-compromised individuals

14 April 2022 - Evusheld is the first long-acting antibody combination to receive Health Canada authorisation for the prevention of ...

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Health Canada has approved Zeposia (ozanimod), an oral treatment for adults with moderately to severely active ulcerative colitis

12 April 2022 - Zeposia is the first and only S1P receptor modulating agent approved for the treatment of ulcerative ...

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Jardiance (empagliflozin) becomes the first and only approved treatment in Canada for adults with chronic heart failure regardless of ejection fraction

12 April 2022 - Jardiance is the first and only heart failure therapy to demonstrate a statistically significant risk reduction in ...

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Health Canada approves Gardasil 9 (human papillomavirus 9 valent vaccine, recombinant) for the prevention of oropharyngeal and other head and neck cancers

11 April 2022 - Gardasil 9 is the first vaccine in Canada approved for the prevention of HPV related oropharyngeal ...

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Janssen announces Health Canada approval of Rybrevant (amivantamab), the first and only targeted treatment for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations

4 April 2022 - Targeting both cancer driving and resistance mechanism pathways, Rybrevant offers a unique treatment approach for an ...

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Seqirus receives Health Canada approval for expanded age indication of its cell-based quadrivalent influenza vaccine for people as young as six months

28 March 2022 - Seqirus announced today that it has received Health Canada approval of Flucelvax Quad (influenza vaccine), its cell-based ...

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