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RSS FeedPosted by Michael Wonder on 27 Dec 2023
Scilex announces filing of a new drug submission to Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of Elyxyb for acute treatment of migraine with or without aura in Canada
26 December 2023 - The anticipated timeline for approval in Canada is approximately 12 months depending on review cycles and ...
Posted by Michael Wonder on 03 Dec 2023
Duchesnay is seeking Health Canada approval for a segesterone acetate/ethinyl estradiol contraceptive vaginal system, a new option for women
30 November 2023 - Duchesnay has recently filed a new drug submission to Health Canada for its segesterone acetate/ethinyl estradiol slow ...
Posted by Michael Wonder on 29 Aug 2023
Health Canada accepts Valneva’s Chikungunya vaccine license application for review
29 August 2023 - Valneva today announced that Health Canada has completed screening validation of the Company’s regulatory application for ...
Posted by Michael Wonder on 30 Jun 2023
Moderna initiates rolling submission to Health Canada for updated COVID-19 vaccine
29 June 2023 - Health Canada submission follows international recommendations to develop monovalent XBB.1.5 COVID-19 vaccines. ...
Posted by Michael Wonder on 12 Jun 2023
Is Canada missing out? An assessment of drugs approved internationally between 2016 and 2020 and not submitted for Health Canada review
12 June 2023 - One-third of the new active substances approved in the United States and Europe between 2016 and ...
Posted by Michael Wonder on 30 May 2023
Valneva files for Chikungunya vaccine authorisation with Health Canada
30 May 2023 - Valneva today announces the filing of a regulatory application with Health Canada for marketing approval of ...
Posted by Michael Wonder on 16 May 2023
Health Canada accepts new drug submission for lecanemab as treatment for early Alzheimer’s disease
15 May 2023 - Eisai and Biogen announced today that Health Canada has accepted a new drug submission for lecanemab for ...
Posted by Michael Wonder on 13 May 2023
Tetra Bio-Pharma cancels new drug submission to Health Canada
11 May 2023 - Tetra Bio-Pharma today announced it has cancelled its new drug submission to Health Canada, without prejudice ...
Posted by Michael Wonder on 09 May 2023
Rhythm Pharmaceuticals announces Health Canada approval of Imcivree setmelanotide injection for weight management in Bardet-Biedl syndrome or genetically-confirmed biallelic POMC, PCSK1, or LEPR deficiency
8 May 2023 - Approval granted following a priority review by Health Canada. ...
Posted by Michael Wonder on 04 May 2023
Health Canada approves Quviviq (daridorexant) for the management of adult patients with insomnia
3 May 2023 - Quviviq is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset ...
Posted by Michael Wonder on 15 Apr 2023
Pfizer Canada initiates submission to Health Canada for its bivalent respiratory syncytial virus vaccine
14 April 2023 - Indications under review include prevention of respiratory syncytial virus in infants from birth through 6 months ...
Posted by Michael Wonder on 27 Jan 2023
Valeo Pharma announces filing of a new drug submission with Health Canada for sabizabulin for the treatment of hospitalised COVID-19 patients
26 January 2023 - In the final analysis of the Phase 3 clinical study conducted by Veru, sabizabulin showed a 51.6% ...
Posted by Michael Wonder on 19 Jan 2023
Health Canada accepts nirsevimab regulatory submission for infant RSV
18 January 2023 - Nirsevimab is the first investigational long-acting antibody designed for all infants to help protect against respiratory syncytial ...
Posted by Michael Wonder on 26 Nov 2022
GSK Canada submits respiratory syncytial virus vaccine candidate for regulatory review
25 November 2022 - Application includes important pivotal Phase 3 data evaluating the efficacy and safety of our vaccine candidate against ...
Posted by Michael Wonder on 09 Aug 2022
Paladin Labs announces Health Canada's filing acceptance of cenobamate tablets as an adjunctive therapy for the management of partial-onset seizures in adults with epilepsy
8 August 2022 - Paladin Labs announced today that Health Canada has accepted its new drug submission for cenobamate tablets as ...