Health Canada approves Adtralza (tralokinumab) for the treatment of adolescents aged 12 to 17 with moderate to severe atopic dermatitis

8 February 2023 - Adtralza is the first treatment for adolescents with moderate to severe atopic dermatitis specifically targeting the ...

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Ultomiris approved in Canada for adults with generalied myasthenia gravis

17 January 2023 - First and only long acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised ...

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Celltrion gets nod from Canadian regulator for sales of Avastin biosimilar

17 January 2023 - Celltrion obtained permission from Health Canada to sell Avastin (bevacizumab) biosimilar Vegzelma (CT-P16) on Tuesday. ...

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Enhertu approved by Health Canada as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer

12 January 2023 - Approval based on the DESTINY-Breast04 results which showed Enhertu reduced risk of disease progression or death ...

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Qulipta now approved by Health Canada for the preventive treatment of episodic migraine in adults

9 January 2023 - Qulipta is the first and only oral calcitonin gene-related peptide receptor antagonist (gepant) specifically developed for the ...

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JAMP Pharma Group receives Health Canada approval for JAMP Sitagliptin, a new generic alternative for the treatment of type 2 diabetes

6 January 2022 - The JAMP Pharma Group is pleased to announce the Health Canada approval of JAMP Sitagliptin, a generic ...

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Samsung Bioepis announces Health Canada approval of citrate free high concentration of Humira biosimilar (adalimumab; SB5)

3 January 2023 - With the approval, Samsung Bioepis has both low (40 mg/0.8 mL) and high (40 mg/0.4 mL) concentration ...

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Aequus announces Health Canada Notice of Compliance for Zimed Preservative Free (bimatoprost 0.03%)

20 December 2022 - Aequus Pharmaceuticals is pleased to announce that Health Canada has approved Zimed PF (bimatoprost 0.03%) for ...

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VBI Vaccines announces Health Canada approval for PreHevbrio for the prevention of hepatitis B in adults

8 December 2022 - VBI Vaccines today announced that Health Canada has approved PreHevbrio [3 antigen hepatitis B vaccine (recombinant)] for ...

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Sobi receives approval from Health Canada for Empaveli (pegcetacoplan) for the treatment of certain patients with paroxysmal nocturnal haemoglobinuria

9 December 2022 - Approval based on results from head to head PEGASUS Phase 3 trial where Empaveli demonstrated superiority to ...

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Capstone announces authorisation of biosimilar human insulin for IV infusion in Canada and EU

29 November 2022 -  Capstone announced today that a biosimilar version of human insulin received authorisation from the EMA's CHMP ...

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Health Canada has approved Sotyku (deucravacitinib tablets), an oral treatment for adults with moderate to severe plaque psoriasis

28 November 2022 - Sotyktu is the first and only approved TYK2 inhibitor in Canada and represents an important milestone ...

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Health Canada authorises Polivy (polatuzumab vedotin) for the first-line treatment of adults with large B-cell lymphoma

24 November 2022 - Authorization is based on pivotal data from the Phase 3 POLARIX trial, which met its primary ...

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Novavax’s COVID-19 booster has been approved for adults, Health Canada says

17 November 2022 - Health Canada said Thursday it has approved the booster dose of Novavax‘s Nuvaxovid COVID-19 vaccine for ...

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Canadian migraine sufferers have a new treatment option - Health Canada approves Ubrelvy (ubrogepant)

16 November 2022 - Ubrelvy is the first and only oral CGRP receptor antagonist (gepant) approved by Health Canada for the ...

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