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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Health Canada approves Camzyos (mavacamten) for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy

10 November 2022 - Camzyos is the only Health Canada approved reversible cardiac myosin inhibitor indicated for the treatment of ...

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Mitsubishi Tanabe Pharma Canada announces Canadian authorisation of Radicava (edarvarone) oral suspension for the treatment of patients with ALS

8 November 2022 - Comprehensive clinical development program for edaravone in ALS has spanned over a decade and included multiple ...

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Health Canada expands Tresiba (insulin degludec injection) label with efficacy and safety for use in pregnant women with diabetes

3 November 2022 - Tresiba, Canada's leading basal insulin, now approved for use during pregnancy. ...

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Actemra IV (tocilizumab for injection) receives authorisation for additional indication from Health Canada for the treatment of COVID-19

28 October 2022 - Actemra is shown to improve outcomes including mortality in patients hospitalised with COVID-19 requiring supplemental oxygen. ...

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Health Canada approves Kerendia (finerenone) as an adjunct to standard of care therapy in adults with chronic kidney disease and type 2 diabetes

26 October 2022 - The approval is based on the results of the Phase 3 FIDELIO-DKD and FIGARO-DKD trial investigating the ...

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AbbVie's Skyrizi (risankizumab) receives Health Canada approval as the first and only specific interleukin-23 to treat moderately to severely active Crohn's disease in adults

20 October 2022 - Third approved indication for Skyrizi (rizankizumab) is supported by safety and efficacy data from two induction and ...

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Evusheld receives Health Canada approval for treatment of COVID-19

18 October 2022 - Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase 3 treatment trial. ...

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Health Canada approves Keytruda (pembrolizumab) as monotherapy for the adjuvant treatment of adults with renal cell carcinoma (RCC) at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions

12 October 2022 - Approval based on data from the Phase 3 KEYNOTE-564 trial. ...

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Santen announces Health Canada approval for Cationorm Plus to relieve the symptoms of dry eye and ocular allergy

6 October 2022 - Santen Canada today announced the approval of Cationorm Plus by Health Canada.  ...

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Health Canada approves additional indication for Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer in combination with docetaxel

5 October 2022 - Today's approval was based on the pivotal Phase 3 ARASENS trial, which showed a significant overall survival ...

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Bausch Health and Glenmark announce the approval of Ryaltris in Canada

23 September 2022 - Ryaltris (olopatadine hydrochloride and mometasone furoate nasal spray) treats moderate to severe seasonal allergic rhinitis and associated ...

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Health Canada approves Takeda's Livtencity (maribavir) the first and only treatment for adults with post-transplant cytomegalovirus infection

20 September 2022 - Takeda Canada is pleased to announce that Health Canada has authorized (Notice of Compliance) Livtencity (maribavir) for ...

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Lupin receives Health Canada approval for Rymti (biosimilar etanercept)

13 September 2022 - Rymti is Lupin’s biosimilar etanercept approved for all indications of the reference product. ...

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Health Canada approves Keytruda (pembrolizumab) as adjuvant treatment for adults and children with stage IIB or IIC melanoma following complete resection

13 September 2022 - Approval is based on the Phase 3 KEYNOTE-716 trial. ...

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