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RSS FeedPosted by Michael Wonder on 22 Feb 2025
Health Canada authorizes Itovebi (inavolisib film-coated tablets), a targeted treatment for advanced hormone receptor-positive, HER2 negative breast cancer with a PIK3CA mutation
19 February 2025 - The approval provides another treatment option for breast cancer patients with a PIK3CA mutation, one of the ...
Posted by Michael Wonder on 21 Feb 2025
Eylea HD pre-filled syringe with OcuClick dosing system granted marketing authorisation in Canada
20 February 2025 - Bayer is pleased to announce that Health Canada has granted marketing authorisation for Eylea HD (aflibercept injection ...
Posted by Michael Wonder on 14 Feb 2025
Novartis receives Health Canada approval for Fabhalta oral treatment for adult patients with paroxysmal nocturnal haemoglobinuria
13 February 2025 - Fabhalta is the first oral monotherapy for previously treated and treatment naïve adults with paroxysmal nocturnal haemoglobinuria. ...
Posted by Michael Wonder on 12 Feb 2025
Health Canada approves Merck's Keytruda (pembrolizumab) for the treatment of adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery
11 February 2025 - Approval is based on the Phase 3 KEYNOTE-671 trial. ...
Posted by Michael Wonder on 21 Jan 2025
Takeda's Fruzaqla (fruquintinib) receives Health Canada market authorisation for metastatic colorectal cancer
20 January 2025 - Positive reimbursement recommendations by Canada's Drug Agency and Institut National d'excellence en Santé et Services Sociaux. ...
Posted by Michael Wonder on 21 Jan 2025
Health Canada authorises Vabysmo (faricimab injection) pre-filled syringe for three leading causes of vision loss
20 January 2025 - Vabysmo pre-filled syringe is the first and only syringe pre-filled with a Health-Canada approved bispecific antibody to ...
Posted by Michael Wonder on 18 Jan 2025
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 ...
Posted by Michael Wonder on 17 Jan 2025
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 ...
Posted by Michael Wonder on 14 Jan 2025
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 ...
Posted by Michael Wonder on 10 Jan 2025
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. ...
Posted by Michael Wonder on 09 Jan 2025
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 ...
Posted by Michael Wonder on 18 Dec 2024
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 ...
Posted by Michael Wonder on 11 Dec 2024
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 ...
Posted by Michael Wonder on 07 Dec 2024
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 ...
Posted by Michael Wonder on 05 Dec 2024
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 ...