Blog
RSS FeedPosted by Michael Wonder on 31 Dec 2021
Celltrion acquires approval for its new Humira 'Yuflyma' in Canada
30 December 2021 - Celltrion announced on December 30 that it won marketing approval from Health Canada for "Yuflyma", a ...
Posted by Michael Wonder on 26 Dec 2021
SIGA announces Health Canada regulatory approval of oral TPOXX
1 December 2021 - SIGA Technologies today announced that Health Canada has approved oral Tpoxx (tecovirimat) as an extraordinary use new ...
Posted by Michael Wonder on 26 Dec 2021
GSK’s Jemperli (dostarlimab for injection) approved in Canada as an anti-PD-1 therapy for recurrent or advanced endometrial cancer
15 December 2021 - GSK announces today that it has been granted Notice of Compliance with conditions for its endometrial ...
Posted by Michael Wonder on 09 Dec 2021
Canada's national strategy for drugs for rare diseases needs a holistic approach
8 December 2021 - International report summarises drugs for rare disease best practices and recommendations. ...
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 26 Nov 2021
Health Canada issues Notice of Compliance for Trodelvy, a new treatment option for an aggressive type of metastatic breast cancer
25 November 2021 - Trodelvy significantly reduced the risk of death by 49% compared with single agent chemotherapy in the ...
Posted by Michael Wonder on 26 Nov 2021
Health Canada approves Wegovy for the treatment of adults with obesity
25 November 2021 - Novo Nordisk announced today that Health Canada has approved Wegovy (semaglutide injection), the first-and-only prescription weight-loss medication ...
Posted by Michael Wonder on 24 Nov 2021
Health Canada approves Keytruda (pembrolizumab) in combination with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple negative breast cancer whose tumours express PD-L1 (CPS ≥10)
23 November 2021 - Conditional approval based on data from Phase 3 KEYNOTE-355 trial; introduces first breast cancer indication for ...
Posted by Michael Wonder on 16 Nov 2021
Nexviazyme (avalglucosidase alfa for injection) is now approved in Canada for patients with late-onset Pompe disease (acid α-glucosidase deficiency)
15 November 2021 - Nexviazyme (avalglucosidase alfa for injection) is now approved in Canada for the long-term treatment of patients older ...
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 ...
Posted by Michael Wonder on 04 Nov 2021
Libtayo (cemiplimab) approved in Canada for the first-line treatment of adult patients with non-small-cell lung cancer expressing PD-L1 in ≥ 50% of tumour cells with no EGFR, ALK or ROS1 aberrations
29 October 2021 - The approval is based on data from the randomised, open-label, multi-center study 16241. ...
Posted by Michael Wonder on 04 Nov 2021
Libtayo (cemiplimab) approved in Canada for locally advanced basal cell carcinoma patients
29 October 2021 - The approval is based on data from the open-label, multi-center, non-randomised study 16201. ...
Posted by Michael Wonder on 03 Nov 2021
Opdivo receives two new Health Canada approvals
2 November 2021 - Today Bristol Myers Squibb Canada announces two recent Health Canada approvals for Opdivo (nivolumab). ...
Posted by Michael Wonder on 03 Nov 2021
Health Canada issues Notice of Compliance for Jardiance (empagliflozin) for the treatment of heart failure with reduced ejection fraction
2 November 2021 - This new indication is based on the EMPEROR-Reduced trial, which showed a significant 25% reduction in the ...
Posted by Michael Wonder on 20 Oct 2021
Chiesi Global Rare Diseases announces approval of Ferriprox (deferiprone) in Canada for the treatment of iron overload in sickle cell disease
15 October 2021 - Chiesi Global Rare Diseases announced today that Health Canada has approved Ferriprox (deferiprone) for the treatment of ...