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RSS FeedPosted by Michael Wonder on 27 Nov 2021
Shingrix approved in Canada for adults at increased risk of shingles due to immunodeficiency or immunosuppression
25 November 2021 - GlaxoSmithKline today announced that Shingrix (Zoster Vaccine Recombinant, Adjuvanted) has been approved in Canada for the prevention ...
Posted by Michael Wonder on 26 Nov 2021
Johnson & Johnson COVID-19 vaccine fully approved by Health Canada to prevent COVID-19 in individuals 18 years and older
24 November 2021 - Vaccine demonstrates protection against COVID-19 related hospitalisation and death, and across different variants. ...
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 21 Nov 2021
Moderna files for authorisation of its COVID-19 vaccine with Health Canada to include children ages 6-11 years
17 November 2021 - Submission based on Phase 2/3 study of SPIKEVAX in children ages 6 to 11. ...
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 13 Nov 2021
Health Canada authorises the use of the Moderna Spikevax COVID-19 vaccine as a booster shot
12 November 2021 - Health Canada has authorised the use of the Moderna Spikevax COVID-19 vaccine as a booster shot. ...
Posted by Michael Wonder on 10 Nov 2021
Health Canada authorises the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine as a booster shot
9 November 2021 - Health Canada has authorized the use of the Pfizer-BioNTech Comirnaty COVID-19 vaccine as a booster shot. ...
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 02 Nov 2021
Novavax files for COVID-19 vaccine authorisation with Health Canada and completes submission for rolling review to European Medicines Agency
1 November 2021 - Submission of all modules required for regulatory review, including CMC and clinical data, are now complete ...