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RSS FeedPosted 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 ...
Posted by Michael Wonder on 29 Oct 2021
Kite's Tecartus (brexucabtagene autoleucel) authorised by Health Canada for the treatment of relapsed or refractory mantle cell lymphoma
28 October 2021 - Tecartus is first CAR T therapy in mantle cell lymphoma and Kite becomes the first company ...
Posted by Michael Wonder on 27 Oct 2021
Vertex's supplement to a new drug aubmission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 6-11 accepted for priority review by Health Canada
27 October 2021 - Vertex Pharmaceuticals today announced that its supplement to a new drug submission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ...
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 ...
Posted by Michael Wonder on 19 Oct 2021
Health Canada receives submission from Pfizer-BioNTech to authorise the use of Comirnaty COVID-19 vaccine in children 5 to 11 years of age
18 October 2021 - Today, Health Canada received a submission from Pfizer-BioNTech seeking an authorisation for the use of its Comirnaty ...
Posted by Michael Wonder on 14 Oct 2021
New Sarclisa (isatuximab) combination now approved by Health Canada for adults with relapsed and/or refractory multiple myeloma
13 October 2021 - The approval is based on data from the Phase 3 IKEMA trial. ...
Posted by Michael Wonder on 08 Oct 2021
Health Canada approves the use of Rinvoq (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis
7 October 2021 - Authorization is based on the results from three Phase 3 multicenter, randomized, double-blind, placebo-controlled registrational clinical trials ...
Posted by Michael Wonder on 07 Oct 2021
Moderna asks Health Canada to approve COVID-19 vaccine booster shot
5 October 2021 - Moderna has applied for Canadian approval of a third dose of its COVID-19 vaccine, the company ...
Posted by Michael Wonder on 05 Oct 2021
The Product Monograph for Protopic has been updated
4 October 2021 - LEO Pharma Inc. today announced that Health Canada has approved an update to the Product Monograph of ...
Posted by Michael Wonder on 01 Oct 2021
PharmaMar announces the approval of Zepzelca (lurbinectedin) for the treatment of relapsed stage III or metastatic small cell lung cancer in Canada
30 September 2021 - Lurbinectedin to become commercially available in Canada in the coming months. ...
Posted by Michael Wonder on 29 Sep 2021
Helsinn Group and BridgeBio Pharma’s affiliate QED Therapeutics announce Health Canada conditional approval of Truseltiq (infigratinib) for patients with cholangiocarcinoma
29 September 2021 - Health Canada issues conditional approval of Truseltiq under Project Orbis (27 September 2021). ...