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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 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 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 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
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 ...
Posted by Michael Wonder on 29 Jan 2026
Cipher Pharmaceuticals announces Health Canada's acceptance for review of new drug submission for Natroba (spinosad)
28 January 2026 - Cipher Pharmaceuticals today announced that Health Canada has accepted for review Cipher's new drug submission for ...
Posted by Michael Wonder on 27 Jan 2026
Health Canada authorises Gazyva (obinutuzumab) for adults with active lupus nephritis
26 January 2026 - Roche Canada is pleased to announce that on 22 January 2026, Health Canada has approved Gazyva ...
Posted by Michael Wonder on 14 Jan 2026
Bimzelz (bimekizumab injection) approved in Canada for treatment of moderate to severe hidradenitis suppurativa
13 January 2026 - The approval is based on clinically significant results from UCB's two pivotal Phase 3 trials demonstrating ...
Posted by Michael Wonder on 13 Jan 2026
Health Canada approves Rybelsus (semaglutide tablets) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes
12 January 2026 - The indication expansion is based on positive outcomes observed in the cardiovascular outcomes (SOUL) trial data, ...
Posted by Michael Wonder on 13 Jan 2026
Galderma announces the authorisation of Nemluvio (nemolizumab) for atopic dermatitis and prurigo nodularis in Canada
12 January 2026 - Nemluvio is now authorised for sale by Health Canada based on results from the Phase III ARCADIA ...