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RSS FeedPosted by Michael Wonder on 06 Nov 2022
Moderna receives Health Canada authorisation for second Omicron targeting bivalent booster
4 November 2022 - mRNA-1273.222 targets BA.4/BA.5 Omicron sub-variants and follows the approval of mRNA-1273.214 (SPIKEVAX Bivalent) in Canada, which ...
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 03 Nov 2022
Health Canada authorises second bivalent COVID-19 booster targeting the Omicron BA.4/5 variants
3 November 2022 - Today, Health Canada authorised an adapted version of the Moderna Spikevax COVID-19 vaccine that targets the Omicron ...
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 28 Oct 2022
Health Canada approves Rebinyn (coagulation factor IX (recombinant), pegylated) for the treatment of routine prophylaxis to prevent or reduce frequency of bleeding episodes in children with haemophilia B
27 October 2022 - Expanded indication for Rebinyn will continue to support Canadian paediatric patients living with haemophilia B. ...
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 14 Oct 2022
Health Canada approves Illuccix for prostate cancer imaging
13 October 2022 - Telix Pharmaceuticals announces that Health Canada has approved Illuccix [kit for the preparation of gallium (Ga 68) ...
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 08 Oct 2022
Health Canada authorises COVID-19 vaccine booster targeting the Omicron BA.4/BA.5 sub-variants
7 October 2022 - Today, Health Canada authorised a second bivalent COVID-19 vaccine booster. ...
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 ...
Posted by Michael Wonder on 21 Sep 2022
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 ...