Blog
RSS FeedPosted by Michael Wonder on 11 Jun 2026
Italfarmaco announces Health Canada acceptance and priority review of new drug submission for givinostat as a Duchenne muscular dystrophy treatment
10 June 2026 - New drug submission is based on Italfarmaco’s Phase 3 EPIDYS trial data demonstrating meaningful treatment benefits ...
Posted by Michael Wonder on 10 Jun 2026
Chiesi Global Rare Diseases announces Health Canada grants priority review for Filsuvez (birch triterpenes) topical gel for the treatment of epidermolysis bullosa
9 June 2026 - Chiesi Global Rare Diseases today announced that Health Canada has accepted the new drug submission for Filzuvez ...
Posted by Michael Wonder on 05 Jun 2026
Kashiv BioSciences announces validation and acceptance of market authorisation application by Health Canada for ADL-018, a proposed biosimilar to Xolair (omalizumab)
4 June 2026 - Kashiv BioSciences today announced that Health Canada has validated and accepted the marketing authorisation application for ADL-018, ...
Posted by Michael Wonder on 03 Jun 2026
Celltrion files for approval of Cosentyx biosimilar, CT-P55, in Canada
1 June 2026 - Celltrion announced on Monday that it has submitted a regulatory application to Health Canada for CT-P55, ...
Posted by Michael Wonder on 22 May 2026
Vertex announces new drug submission for suzetrigine has been accepted for review by Health Canada for the treatment of moderate to severe acute pain in adults
21 May 2026 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review a new drug submission for ...
Posted 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 ...