Tagrisso approved (with conditions) in Canada for patients with unresectable, stage III EGFR-mutated non-small cell lung cancer

21 May 2025 - Based on LAURA Phase 3 trial results which showed patients who took Targrisso after CRT had ...

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Lilly Canada announces availability of Mounjaro KwikPen (tirzepatide) in all doses, advancing care for adults living with type 2 diabetes

13 May 2025 - The multi-dose, single-patient-use, pre-filled pen allows for personalised treatment plans that can cater to individual patient ...

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Itulatek approved for treatment of children and adolescents in Canada

8 May 2025 - ALK today announced that Health Canada has approved ALK’s regulatory filing for Itulatek (tree pollen sublingual allergy ...

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Health Canada has granted approval for Tzield, the first and only disease-modifying therapy in auto-immune type 1 diabetes in Canada

5 May 2025 - Tzield is demonstrated to delay by a median of 2 years the onset of Stage 3 type ...

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Health Canada accepts semaglutide 2.4 mg, a GLP-1 receptor agonist treatment for MASH, as a supplemental new drug submission under the priority review policy

2 May 2025 - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the priority review policy, ...

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Health Canada approves Iqirvo as a first-in-class dual-peroxisome proliferator-activated receptor treatment for primary biliary cholangitis

28 April 2025 - Iqirvo (elafibranor) is the first new medicine approved in nearly a decade for the treatment of ...

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Sarclisa approved in Canada for patients with newly diagnosed multiple myeloma

22 April 2025 - This is the third indication for Sarclisa in Canada for the treatment of multiple myeloma. ...

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Health Canada approves Keytruda plus pemetrexed and platinum chemotherapy as first-line treatment for adult patients with unresectable advanced or metastatic malignant pleural mesothelioma

22 April 2025 - Approval is based on the results from the Phase 3 CCTG IND.227/KEYNOTE-483 trial. ...

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Health Canada expands Jemperli (dostarlimab for injection) plus chemotherapy approval to all adult patients with primary advanced or first recurrent endometrial cancer, as the first and only immuno-oncology-based treatment to show an overall survival benefit for these patients

17 April 2025 - Approval based on RUBY Part 1 trial, where Jemperli plus chemotherapy demonstrated a statistically significant and ...

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Scilex announces approval of a new drug submission from the Health Canada for Elyxyb’s acute treatment of migraine with or without aura in Canada

15 April 2025 - Elyxyb is a first-line treatment and the only FDA approved, ready to use oral solution for the ...

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Health Canada approves Nduvra (tapinarof 1% cream) for the topical treatment of plaque psoriasis in adults

14 April 2025 - Organon today announced that Health Canada has approved Nduvra (tapinarof cream), 1%, the first in a novel ...

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Health Canada approves Imfinzi (durvalumab) as the first and only immunotherapy regimen for adult patients with limited-stage small cell lung cancer

10 April 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab), as monotherapy, for the treatment ...

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Catalyst Pharmaceuticals announces Health Canada’s acceptance of Agamree new drug submission with priority review

8 April 2025 - Catalyst Pharmaceuticals today reported that its sub-licensee in Canada, Kye Pharmaceuticals has announced that Health Canada has ...

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Rystiggo now approved for adults with generalised myasthenia gravis in Canada

2 April 2025 - The approval is supported by the pivotal Phase 3 MycarinG study in gMG, which demonstrated that treatment ...

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Takeda’s HyQvia receives expanded market authorisation as maintenance therapy for chronic inflammatory demyelinating polyneuropathy

27 March 2025 - HyQvia is the only up to once monthly (every 2, 3 or 4 weeks) immunoglobulin subcutaneous ...

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