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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 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 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 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 06 Jan 2026
Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine
5 January 2026 - Moderna today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults ...
Posted by Michael Wonder on 13 Nov 2025
Marius Pharmaceuticals expands global footprint with Health Canada approval of Kyzatrex (testosterone undecanoate) CIII capsules
12 November 2025 - Marius Pharmaceuticals today announced that Health Canada has approved Kyzatrex (testosterone undecanoate) CIII capsules. ...
Posted by Michael Wonder on 27 Oct 2025
Health Canada grants authorisation for Leqembi (lecanemab) for the treatment of early Alzheimer’s disease
26 October 2025 - Eisai and Biogen announced today that Health Canada has issued a notice of compliance with conditions for ...
Posted by Michael Wonder on 06 Sep 2025
Sol-Gel announces Health Canada approval of Epsolay
4 September 2025 - - Sol-Gel Technologies announced today that on 27 August 2 2025 Health Canada issued a Notice ...
Posted by Michael Wonder on 09 Aug 2025
Health Canada has authorised CSL's Andembry (garadacimab) as once monthly treatment for hereditary angioedema
8 August 2025 - CSL today announced that Health Canada has granted a marketing authorisation for Andembry (garadacimab) for routine ...
Posted by Michael Wonder on 23 Jul 2025
Bavarian Nordic receives acceptance from Health Canada for review of the new drug submission for its chikungunya vaccine
22 July 2025 - Bavarian Nordic announced today that Health Canada has accepted for review the Company’s application for licensure ...
Posted by Michael Wonder on 19 Jul 2025
Knight Therapeutics announces filing of new drug submission for Crexont (carbidopa and levodopa) extended release capsules in Canada
18 July 2025 - Knight Therapeutics announced today that Knight's new drug submission for Crexont has been accepted for review ...
Posted by Michael Wonder on 10 Jun 2025
Lipocine announces filing of new drug submission for Tlando in Canada
9 June 2025 - New drug submission filed by Lipocine's licensing partner Verity Pharma. ...
Posted by Michael Wonder on 27 May 2025
GSK's depemokimab accepted for review by Health Canada for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps
26 May 2025 - GSK has submitted a new drug submission to Health Canada for depemokimab for two proposed indications: the ...
Posted by Michael Wonder on 04 May 2025
Health Canada accepts semaglutide 2.4 mg, a GLP-1 receptor agonist treatment for MASH, as a supplemental new drug submission under the priority review policy
2 May 2025 - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the priority review policy, ...