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RSS FeedPosted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 29 Nov 2022
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 ...
Posted by Michael Wonder on 25 Nov 2022
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 ...
Posted by Michael Wonder on 17 Nov 2022
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 ...
Posted by Michael Wonder on 11 Nov 2022
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 ...
Posted by Michael Wonder on 09 Nov 2022
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 ...
Posted by Michael Wonder on 04 Nov 2022
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. ...
Posted by Michael Wonder on 29 Oct 2022
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. ...
Posted by Michael Wonder on 27 Oct 2022
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 ...
Posted by Michael Wonder on 20 Oct 2022
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 ...
Posted by Michael Wonder on 19 Oct 2022
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. ...
Posted by Michael Wonder on 13 Oct 2022
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. ...
Posted by Michael Wonder on 06 Oct 2022
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. ...
Posted by Michael Wonder on 06 Oct 2022
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 ...
Posted by Michael Wonder on 24 Sep 2022
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 ...