Long wait for cancer drug approvals causing 'great anguish' among patients, doctors

18 January 2025 - Potentially life-saving treatments delayed by bureaucracy, doctors say. ...

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Health Canada approves Otsuka and Lundbeck's Abilify Asimtufii (aripiprazole), the first and only, once every two months, long-acting injectable treatment for schizophrenia and for maintenance monotherapy of bipolar I disorder in adults

17 January 2025 - Otsuka Pharmaceutical Canada and Lundbeck Canada announce that Health Canada has issued a Notice of Compliance ...

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Rybrevant plus chemotherapy approved in Canada as first and only targeted treatment to reduce risk of disease progression or death by more than half in second-line EGFR mutated advanced lung cancer

16 January 2025 - Phase 3 MARIPOSA-2 study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival compared ...

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CAR T cell therapy Breyanzi (lisocabtagene maraleucel) approved for second-line relapsed or refractory diffuse large B-cell lymphoma

13 January 2024 - In the pivotal Phase 3 TRANSFORM trial, Breyanzi demonstrated a significant improvement in event-free survival over ...

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Astellas receives Health Canada approval for Vyloy (zolbetuximab) in combination with chemotherapy for advanced gastric and gastro-oesophageal junction cancer

9 January 2024 - Canada's Drug Agency recently issued draft recommendation to reimburse Vyloy with conditions. ...

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Fresenius Kabi Canada has received a Health Canada Notice of Compliance for Otulfi an ustekinumab biosimilar

8 January 2025 - Otulfi received a Health Canada Notice of Compliance approval on 30 December 2024 for both subcutaneous and ...

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Knight Therapeutics announces filing of new drug submission for Qelbree (viloxazine) in Canada

16 December 2024 - Knight Therapeutics announced today that Knight's new drug submission for Qelbree (viloxazine extended-release capsules) has been accepted ...

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Health Canada approves Xeomin (incobotulinumtoxinA) for treatment of adults with post-stroke lower limb spasticity in the ankle and foot

17 December 2024 - Merz Therapeutics today announced that Health Canada approved Xeomin (incobotulinumtoxinA) for the treatment of post-stroke lower limb ...

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Health Canada approves Celltrion’s Omlyclo (CT-P39), the first and only omalizumab biosimilar in Canada

9 December 2024 - Omlyclo (CT-P39) is the first and only omalizumab biosimilar referencing Xolair approved in Canada to treat multiple ...

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Veozah (fezolinetant film coated tablets) receives Health Canada approval as first and only non-hormonal treatment for vasomotor symptoms associated with menopause

3 December 2024 - New treatment option helps fill unmet need for women experiencing hot flashes and night sweats associated ...

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Esperion announces new drug submissions in Canada for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) treatments to reduce LDL-cholesterol and cardiovascular risk

2 December 2024 - Esperion today announced that it has filed new drug submissions to Health Canada for Nexletol and Nexlizet, ...

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Health Canada approves Wegovy (semaglutide injection) to reduce the risk of non-fatal myocardial infarction

27 November 2024 - Wegovy is the first and only medication indicated for both chronic weight management and to reduce the ...

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Health Canada authorises Carvykti (ciltacabtagene autoleucel) for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy

21 November 2024 - Authorisation is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with ...

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Knight Therapeutics announces Health Canada approval for Jornay PM to treat attention deficit hyperactivity disorder

14 November 2024 - Knight Therapeutics announced today that Health Canada has approved Jornay PM, an extended-release formulation of methylphenidate, a ...

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Ojjaara (momelotinib) approved in Canada for the treatment of myelofibrosis in adults who have moderate to severe anaemia

12 November 2024 - Ojjaara (momelotinib) is the only approved treatment for newly diagnosed and previously treated myelofibrosis patients who have ...

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