Sandoz receives Health Canada approval for Jubbonti, first and only denosumab biosimilar for treatment of osteoporosis

20 February 2024 - Biosimilar Jubbonti approved for all indications of Prolia reference medicine. ...

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Health Canada approves Remsima SC for the treatment of inflammatory bowel disease

18 February 2024 - The approval is based on results from the LIBERTY studies demonstrating superior efficacy and comparable safety profiles ...

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Elrexfio is authorised by Health Canada for adults with relapsed or refractory multiple myeloma in Canada

13 February 2024 - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions to Elrexfio ...

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Health Canada approves Keytruda in combination with trastuzumab and chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1

12 February 2024 - Approval is based on the Phase 3 KEYNOTE-811 Trial. ...

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Health Canada approves Brukinsa (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma

7 February 2024 - Brukinsa is the first and only BTK inhibitor approved for follicular lymphoma in Canada. ...

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Chiesi Global Rare Diseases announces Health Canada approval of Myalepta (metreleptin for injection) for the treatment of patients with lipodystrophy

5 February 2024 - Canadian patients living with this ultra-rare condition welcome this new treatment option. ...

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Lilly's Olumiant (baricitinib) now authorised in Canada for adults with severe alopecia areata

30 January 2024 - 17-22% of patients taking Olumiant 2 mg/day and 32-35% of patients taking Olumiant 4 mg/day achieved 80% ...

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Xtandi (enzalutamide) receives Health Canada approval as the first and only treatment for high risk patients with non-metastatic castration sensitive prostate cancer

30 January 2024 - Today, Astellas Pharma Canada announced that Health Canada has approved a supplemental new drug application for ...

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Health Canada approves Otsuka and Lundbeck's Rexulti (brexpiprazole) for the symptomatic management of agitation associated with Alzheimer's dementia

24 January 2024 - Otsuka Pharmaceutical Canada and Lundbeck Canada announce that Health Canada has issued a Notice of Compliance ...

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Jardiance (empagliflozin) receives authorisation from Health Canada for the treatment of adults with chronic kidney disease

23 January 2024 - Health Canada has authorised Jardiance (empagliflozin) to reduce the risk of sustained eGFR decline, end stage kidney ...

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Health Canada approves Uplinza (inebilizumab) for the treatment of neuromyelitis optica spectrum disorders

16 January 2024 - First and only anti-CD19 B-cell-depleting monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders ...

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Health Canada approves Pfizer's bivalent respiratory syncytial virus vaccine for older adults and infants through maternal immunisation

4 January 2024 - Abrysvo is the only RSV vaccine authorised in Canada for maternal immunisation. ...

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Health Canada approves Pfizer Canada's gene therapy in haemophilia B

3 January 2024 - Pfizer Canada announced that Health Canada approved Beqvez (fidanacogene elaparvovec), an adeno-associated viral vector-based gene therapy for ...

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Health Canada approves FYB201/Ranopto (ranibizumab), a biosimilar to Lucentis

7 December 2023 - Formycon, Polpharma Biologics, Bioeq and Teva Canada jointly announce that Health Canada has granted the Notice ...

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Lilly announces Health Canada's authorisation of Verzenio (abemaciclib) label expansion

7 December 2023 - Verzenio's label expanded to include the full study population investigated in the Verzenio Phase 3 monarchE trial. ...

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