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RSS FeedPosted 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 ...
Posted by Michael Wonder on 11 Jul 2022
Arcutis Biotherapeutics announces Health Canada accepts for review the new drug submission for roflumilast cream for adults and adolescents with plaque psoriasis
11 July 2022 - Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as ...
Posted by Michael Wonder on 06 Jul 2022
Regulatory submission for GSK's daprodustat accepted into Health Canada review
6 July 2022 - Canadian regulatory submission acceptance follows that of the US FDA and the EMA as well as ...
Posted by Michael Wonder on 14 May 2022
Health Canada accepts SNDS filing and grants priority review of oral edarvarone formulation for the treatment of ALS
13 May 2022 - Mitsubishi Tanabe Pharma Canada announced today that Health Canada has accepted the filing of a supplement to ...
Posted by Michael Wonder on 22 Mar 2022
KYE Pharmaceuticals files Accrufer new drug submission in Canada for the treatment of iron deficiency
21 March 2022 - Shield Therapeutics announces that KYE Pharmaceuticals has submitted a new drug submission to Health Canada for ...
Posted by Michael Wonder on 10 Dec 2021
VBI Vaccines announces filing of new drug submission for 3 antigen hepatitis B vaccine to Health Canada
9 December 2021 - VBI Vaccines today announced the filing of a new drug submission to Health Canada for the Company’s ...
Posted by Michael Wonder on 02 Dec 2021
Pfizer Canada initiates submission to Health Canada for COVID-19 oral anti-viral candidate
1 December 2021 - Pfizer Canada today initiated the filing of a rolling new drug submission with Health Canada for its ...
Posted by Michael Wonder on 05 Nov 2021
AstraZeneca Canada files for Health Canada authorisation of AZD7442 for prevention of COVID-19
3 November 2021 - AstraZeneca Canada has initiated a rolling review new drug submission with Health Canada for authorization of ...