Rinvoq (upadacitinib) receives Health Canada notice of compliance for giant cell arteritis in adults

27 August 2025 - This marks the eighth approved indication for Rinvoq in Canada across rheumatology, gastro-enterology and dermatology. ...

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Leo Pharma announces Health Canada approval of Anzupgo for treatment of moderate to severe chronic hand eczema

26 August 2025 - Approval was based on results from the DELTA 1 and 2 trials, which evaluated the safety and ...

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Moderna receives Health Canada approval for updated COVID-19 vaccine targeting SARS-CoV-2 variant LP.8.1

22 August 2025 - All 2025 pre-filled syringe doses to be made in Canada, marking a domestic production milestone. ...

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Health Canada approves Roche’s Columvi (glofitamab) as the first bi-specific antibody in Canada for relapsed or refractory diffuse large B-cell lymphoma after initial therapy

21 August 2025 -  Approval is based on Phase 3 STARGLO study where Columvi in combination with chemotherapy showed a ...

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Health Canada grants marketing authorisation for an additional indication of Bayer's Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer

21 August 2025 - Bayer is pleased to announce that Health Canada has granted marketing authorisation for its oral androgen receptor ...

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Health Canada approves dual immunotherapy Opdivo plus Yervoy for colorectal and liver cancers

19 August 2025 - Bristol Myers Squibb Canada today announced that Health Canada has approved Opdivo (nivolumab) in combination with ...

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Health Canada approves Ozempic to reduce the risk of sustained eGFR decline, end stage kidney disease, and cardiovascular death in adults with type 2 diabetes and chronic kidney disease

19 August 2025 - Novo Nordisk announced today that Ozempic (semaglutide injection) is now approved as the first and only ...

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Pfizer Canada and BioNTech receive Health Canada approval of LP.8.1 variant adapted COVID-19 vaccine

18 August 2025 - LP.8.1 variant adapted COVID-19 vaccine Cominaty is now authorised in Canada for individuals 6 months of age ...

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Iovance’s Amtagvi (lifileucel) receives Health Canada approval for advanced melanoma

18 August 2025 -  Iovance Biotherapeutics today announced Health Canada has issued a Notice of Compliance with Conditions for Amtagvi ...

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Valneva’s chikungunya vaccine Ixchiq now authorised in Canada for individuals aged 12 and plder

18 August 2025 - Valneva today announced that Health Canada has granted marketing authorisation for its single dose vaccine, Ixchiq, ...

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Health Canada approves Keytruda for patients with resectable locally advanced head & neck squamous cell carcinoma tumours that are PD-L1 (CPS) positive as neo-adjuvant treatment, continued as adjuvant treatment combined with radiotherapy with or without cisplatin then as monotherapy

13 August 2025 - Approval is based on KEYNOTE-689 Phase III clinical trial results. ...

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Imfinzi approved in Canada as first and only peri-operative immunotherapy for muscle invasive bladder cancer

6 August 2025 -  Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab) for the treatment of patients ...

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Health Canada has authorised CSL's Andembry (garadacimab) as once monthly treatment for hereditary angioedema

8 August 2025 - CSL today announced that Health Canada has granted a marketing authorisation for Andembry (garadacimab) for routine ...

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Kye Pharmaceuticals announces the approval of Dynavel XR (amphetamine extended release) tablets and oral suspension for the treatment of adults and children with ADHD

5 August 2025 - Kye Pharmaceuticals is pleased to announce the Health Canada approval (notice of compliance) for Dyanavel XR ...

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Health Canada expands approval of Scemblix, making it an option for newly diagnosed and previously treated chronic myeloid leukaemia patients

30 July 2025 - Scemblix is first to show superior efficacy and a favourable safety and tolerability profile in a Phase ...

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