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RSS FeedPosted by Michael Wonder on 09 Apr 2025
Catalyst Pharmaceuticals announces Health Canada’s acceptance of Agamree new drug submission with priority review
8 April 2025 - Catalyst Pharmaceuticals today reported that its sub-licensee in Canada, Kye Pharmaceuticals has announced that Health Canada has ...
Posted by Michael Wonder on 07 Mar 2025
Ferring receives Health Canada approval for Rebyota (faecal microbiota, live)
6 March 2025 - A novel first in class microbiome restoration therapy for the prevention of recurrence of C. difficile infection. ...
Posted by Michael Wonder on 14 Feb 2025
Novartis receives Health Canada approval for Fabhalta oral treatment for adult patients with paroxysmal nocturnal haemoglobinuria
13 February 2025 - Fabhalta is the first oral monotherapy for previously treated and treatment naïve adults with paroxysmal nocturnal haemoglobinuria. ...
Posted by Michael Wonder on 21 Dec 2024
Knight Therapeutics announces filing of new drug submission for Qelbree (viloxazine) in Canada
16 December 2024 - Knight Therapeutics announced today that Knight's new drug submission for Qelbree (viloxazine extended-release capsules) has been accepted ...
Posted by Michael Wonder on 06 Dec 2024
Esperion announces new drug submissions in Canada for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) treatments to reduce LDL-cholesterol and cardiovascular risk
2 December 2024 - Esperion today announced that it has filed new drug submissions to Health Canada for Nexletol and Nexlizet, ...
Posted by Michael Wonder on 02 Oct 2024
Clinuvel files Canadian new drug submission for Scenesse in EPP
30 September 2024 - Patient special access program continues during Health Canada review. ...
Posted by Michael Wonder on 29 Sep 2024
Vertex announces Health Canada acceptance of new drug submission for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
26 September 2024 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review its new drug submission for ...
Posted by Michael Wonder on 19 Sep 2024
Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada
18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted 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 ...