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 ...

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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 ...

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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. ...

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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. ...

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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. ...

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Opdivo receives two new Health Canada approvals

2 November 2021 -  Today Bristol Myers Squibb Canada announces two recent Health Canada approvals for Opdivo (nivolumab).  ...

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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 ...

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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 ...

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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 ...

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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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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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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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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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