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RSS FeedPosted by Michael Wonder on 10 Mar 2026
Koselugo approved in Canada for plexiform neurofibromas in adults with neurofibromatosis type 1
9 March 2026 - Approval based on KOMET Phase 3 trial results which showed 20% objective response rate in tumour ...
Posted by Michael Wonder on 08 Mar 2026
Ottawa should allow all drugs approved in the EU and US to be marketed in Canada
7 March 2026 - The FederalGovernment plans to speed up some drug approvals in Canada by allowing Health Canada to ...
Posted by Michael Wonder on 06 Mar 2026
HLS Therapeutics announces Nilemdo (bempedoic acid) is now available in Canada for the reduction of LDL-cholesterol in patients at risk of cardiovascular disease
5 March 2026 - HLS Therapeutics today announced the commercial launch of Nilemdo (bempedoic acid) in Canada. Nilemdo is now available ...
Posted by Michael Wonder on 03 Mar 2026
Health Canada Approves Ozempic (semaglutide injection) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes
2 March 2026 - Novo Nordisk announced today that Health Canada has approved Ozempic (semaglutide injection) to reduce the risk of ...
Posted by Michael Wonder on 28 Feb 2026
Pendopharm announces the commercialisation of Buccolam in Canada
27 February 2026 - Pendopharm is pleased to announce that Buccolam is now available in Canada. ...
Posted by Michael Wonder on 18 Feb 2026
Health Canada approves Keytruda SC, a subcutaneous formulation of pembrolizumab across multiple cancer indications
17 February 2026 - Merck announced today that Health Canada has approved Keytruda SC (pembrolizumab injection), a new subcutaneous formulation of ...
Posted by Michael Wonder on 12 Feb 2026
Price, therapeutic value impact international submission times for new drugs
11 February 2026 - The US tends to receive regulatory submissions earlier and more often than other major international regulators, ...
Posted by Michael Wonder on 12 Feb 2026
BioMarin receives Health Canada Notice of Compliance with conditions for Voxzogo for achondroplasia
11 February 2026 - BioMarin has today announced Health Canada has granted a Notice of Compliance with Conditions for Voxzogo ...
Posted by Michael Wonder on 07 Feb 2026
Pendopharm announces the approval of Yorvipath (palopegteriparatide injection) for the treatment of chronic hypoparathyroidism in adults
6 February 2026 - Pendopharm announced today that Health Canada has granted market authorisation for Yorvipath (palopegteriparatide injection), a parathyroid ...
Posted by Michael Wonder on 07 Feb 2026
Kisqali receives positive draft recommendation from Canada's Drug Agency for all eligible early breast cancer patients at high risk of recurrence
6 February 2026 - The draft recommendation for Kisqali (ribociclib tablets) from Canada's Drug Agency (CDA-AMC) supports public reimbursement for hormone ...
Posted by Michael Wonder on 06 Feb 2026
Teva Canada announces approval of expanded indication of Ajovy (fremanezumab solution for subcutaneous injection), the first anti-CGRP preventive treatment for paediatric episodic migraine
4 February 2026 - Teva Canada announced today that Health Canada has approved an expanded indication for Ajovy (fremanezumab solution for ...
Posted by Michael Wonder on 06 Feb 2026
Merck announces Health Canada approval of Enflonsia for the prevention of RSV in newborns and infants
5 February 2026 - Approval is based on the CLEVER and SMART clinical trial results. ...
Posted by Michael Wonder on 03 Feb 2026
Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, now available in Canada for adult patients with relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukaemia
27 January 2026 - The approval of Jaypirca marks Lilly Canada's first haematology launch in Canada. ...
Posted by Michael Wonder on 03 Feb 2026
Health Canada grants authorization for Bayer’s Hyrnuo (sevabertinib) for previously treated patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer
2 February 2026 - Bayer is pleased to announce that Health Canada has authorized Hyrnuo (sevabertinib), oral tablets, for the treatment ...
Posted by Michael Wonder on 30 Jan 2026
Celltrion secures Canadian approval for Omlyclo 300 mg PFS and auto-injector formulations
29 January 2026 - Celltrion said Thursday that it has received additional approval from Health Canada for its chronic idiopathic ...