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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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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). ...

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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 ...

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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.  ...

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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 ...

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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. ...

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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), ...

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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 ...

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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 ...

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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 ...

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Ultragenyx Canada announces Health Canada approval of a second indication for Crysvita (burosumab injection) for the treatment of tumour induced osteomalacia in adults

7 September 2021 - Ultragenyx Pharmaceutical today announced that Crysvita (burosumab Injection) has been approved by Health Canada for the treatment ...

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