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RSS FeedPosted 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 ...
Posted by Michael Wonder on 30 Nov 2024
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 ...
Posted by Michael Wonder on 15 Nov 2024
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 ...
Posted by Michael Wonder on 13 Nov 2024
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 ...
Posted by Michael Wonder on 09 Nov 2024
Moderna receives Health Canada approval for RSV vaccine for adults aged 60 years and older
8 November 2024 - mRESVIA is Moderna's second approved product in Canada, the first mRNA vaccine against RSV, and the only ...
Posted by Michael Wonder on 06 Nov 2024
Expanded age indication for GSK's Arexvy, the first respiratory syncytial virus vaccine approved in Canada for adults aged 50-59 at increased risk
5 November 2024 - Clinical development program continues to evaluate safety and immunogenicity in adults aged 18-49 at increased risk ...
Posted by Michael Wonder on 23 Oct 2024
Health Canada approves first and only oral targeted treatment for brain cancer
22 October 2024 - Pivotal Phase 3 study shows significant improvement in progression-free survival with a favourable safety profile. ...