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RSS FeedPosted 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). ...
Posted by Michael Wonder on 27 Sep 2021
Gilead marks fifth approval for Trodelvy in metastatic triple negative breast cancer under Project Orbis initiative with Health Canada authorisation
27 September 2021 - Antibody-drug conjugate Trodelvy is first treatment to show survival benefit versus standard of care in metastatic triple ...
Posted by Michael Wonder on 27 Sep 2021
Canadian cancer patients have new affordable treatment option
27 September 2021 - Apobiologix expanded its leadership in Canada's biosimilar market with the approval of its first therapeutic treatment, Bambevi. ...
Posted by Michael Wonder on 25 Sep 2021
Vertex's supplement to a new drug submission for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene accepted for priority review by Health Canada
22 September 2021 - Vertex Pharmaceuticals today announced its supplement to a new drug submission for Kalydeco (ivacaftor) has been ...
Posted by Michael Wonder on 22 Sep 2021
Jubilant Radiopharma announces Eckert & Ziegler's GalliaPharm approved for use with NETSpot in Canada
22 September 2021 - Jubilant Radiopharma is the exclusive distributor of GalliaPharm in Canada. ...
Posted by Michael Wonder on 18 Sep 2021
Incyte announces Health Canada conditional approval of Pemazyre (pemigatinib) as first targeted treatment for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma
17 September 2021 - Incyte today announced that Health Canada has granted a Notice of Compliance with conditions for Pemazyre (pemigatinib), ...
Posted by Michael Wonder on 17 Sep 2021
Pfizer-BioNTech COVID-19 vaccine Comirnaty receives full Health Canada approval for individuals 12 years and older
16 September 2021 - Health Canada Notice of Compliance is based on a comprehensive submission package including six month efficacy ...
Posted by Michael Wonder on 16 Sep 2021
Moderna announces Health Canada approves its COVID-19 vaccine
16 September 2021 - Moderna today announced Health Canada has approved the new drug submission for Spikevax (elasomeran mRNA vaccine), which ...
Posted by Michael Wonder on 15 Sep 2021
Health Canada approves Lumakras (sotorasib), the first and only targeted treatment for patients with KRAS G12C mutated locally advanced or metastatic non--small cell lung cancer
14 September 2021 - Once daily dosing option now available to address KRAS G12C, a driver of tumour growth found ...