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RSS FeedPosted by Michael Wonder on 10 Dec 2022
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 ...
Posted by Michael Wonder on 10 Dec 2022
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 ...
Posted 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 19 Nov 2022
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 ...
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 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 ...