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RSS FeedPosted by Michael Wonder on 18 Sep 2024
Biogen's new drug submission for omaveloxolone accepted for priority review by Health Canada for the treatment of Friedreich's ataxia
17 September 2024 - If approved, omaveloxolone would be the only disease specific treatment option for patients living with this progressive ...
Posted by Michael Wonder on 02 Aug 2024
Marius Pharmaceuticals submits Kyzatrex (testosterone undecanoate) capsules for approval to Health Canada
30 July 2024 - Marius Pharmaceuticals is pleased to announce the submission of its new drug submission for Kyzatrex (testosterone ...
Posted by Michael Wonder on 27 Jul 2024
Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...
Posted by Michael Wonder on 03 Jul 2024
Novavax submits application to Health Canada for updated protein-based 2024-2025 formula COVID-19 vaccine
2 July 2024 - Novavax's filing is aligned with NACI, US. FDA, EMA and WHO recommendations on vaccine composition. ...
Posted by Michael Wonder on 26 Jun 2024
Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older
25 June 2024 - Patients treated with Ebglyss experienced significant skin clearance and itch relief as early as 4 weeks. ...
Posted by Michael Wonder on 23 Apr 2024
Acadia Pharmaceuticals announces trofinetide new drug submission for treatment of Rett syndrome has been accepted for filing and priority review by Health Canada
22 April 2024 - Acadia Pharmaceuticals today announced that Health Canada has accepted its new drug submission for trofinetide for the ...
Posted by Michael Wonder on 10 Apr 2024
AB Science announces that Health Canada has granted eligibility for reconsideration request for masitinib in ALS
3 April 2024 - AB Science today announced that Health Canada has granted eligibility for reconsideration request for masitinib in ...
Posted by Michael Wonder on 03 Apr 2024
Vertex announces new drug submission for exagamglogene autotemcel (exa-cel) has been accepted for priority review by Health Canada for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
1 April 2024 - Exa-cel is the first CRISPR-based gene-edited therapy to be submitted for Health Canada review. ...
Posted by Michael Wonder on 21 Mar 2024
Health Canada accepts for review new drug submission for tofersen for treatment of rare, genetic form of ALS
19 March 2024 - Health Canada regulatory decision on tofersen new drug submission expected in early 2025. ...
Posted by Michael Wonder on 05 Mar 2024
AB Science today announces that Health Canada has issued a screening acceptance letter for the application of masitinib in the treatment of amyotrophic lateral sclerosis
9 May 2023 - AB Science today announces that Health Canada has issued a screening acceptance letter for ...
Posted by Michael Wonder on 27 Feb 2024
GSK's RSV vaccine, Arexvy, accepted for review by Health Canada for prevention of RSV disease in adults aged 50-59 at increased risk
26 February 2024 - Submission supported by positive results of a Phase 3 study showing immune response and tolerability in adults ...
Posted by Michael Wonder on 31 Jan 2024
GSK Canada's submission for momelotinib for the treatment of myelofibrosis accepted for review by Health Canada
30 January 2024 - GSK announces that Heath Canada has accepted into review the new drug submission for momelotinib, a potential ...
Posted by Michael Wonder on 12 Jan 2024
Health Canada grants priority review status of ViiV Healthcare's new drug submission for cabotegravir long-acting injectable and tablets for prevention of HIV
10 January 2024 - Application is supported by data from the pivotal Phase 2b/3 studies evaluating safety and efficacy of long-acting ...
Posted by Michael Wonder on 11 Jan 2024
Arcutis Canada announces Health Canada acceptance of the supplement to a new drug submission for roflumilast 0.3% foam for the treatment of seborrheic dermatitis in individuals 9 years of age and older
8 January 2024 - Supplement to a new drug submission supported by positive Phase 2 and Phase 3 pivotal trial ...
Posted by Michael Wonder on 28 Dec 2023
Celltrion seeks approval for Xolair biosimilar in Canada
27 December 2023 - Celltrion said Wednesday that it has completed the submission of its marketing authorisation application for its ...