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RSS FeedPosted by Michael Wonder on 31 Jan 2024
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% ...
Posted by Michael Wonder on 31 Jan 2024
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 ...
Posted by Michael Wonder on 31 Jan 2024
GSK Canada's submission for momelotinib for the treatment of myelofibrosis accepted for review by Health Canada
30 January 2024 - GSK announces that Heath Canada has accepted into review the new drug submission for momelotinib, a potential ...
Posted by Michael Wonder on 25 Jan 2024
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 ...
Posted by Michael Wonder on 24 Jan 2024
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 ...
Posted by Michael Wonder on 18 Jan 2024
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 ...
Posted by Michael Wonder on 12 Jan 2024
Health Canada grants priority review status of ViiV Healthcare's new drug submission for cabotegravir long-acting injectable and tablets for prevention of HIV
10 January 2024 - Application is supported by data from the pivotal Phase 2b/3 studies evaluating safety and efficacy of long-acting ...
Posted by Michael Wonder on 11 Jan 2024
Arcutis Canada announces Health Canada acceptance of the supplement to a new drug submission for roflumilast 0.3% foam for the treatment of seborrheic dermatitis in individuals 9 years of age and older
8 January 2024 - Supplement to a new drug submission supported by positive Phase 2 and Phase 3 pivotal trial ...
Posted by Michael Wonder on 06 Jan 2024
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. ...
Posted by Michael Wonder on 04 Jan 2024
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 ...
Posted by Michael Wonder on 28 Dec 2023
Celltrion seeks approval for Xolair biosimilar in Canada
27 December 2023 - Celltrion said Wednesday that it has completed the submission of its marketing authorisation application for its ...
Posted by Michael Wonder on 27 Dec 2023
Scilex announces filing of a new drug submission to Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of Elyxyb for acute treatment of migraine with or without aura in Canada
26 December 2023 - The anticipated timeline for approval in Canada is approximately 12 months depending on review cycles and ...
Posted by Michael Wonder on 08 Dec 2023
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 ...
Posted by Michael Wonder on 08 Dec 2023
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. ...
Posted by Michael Wonder on 05 Dec 2023
Litfulo receives Health Canada approval, becoming the first approved treatment for severe alopecia areata in Canada
4 December 2023 - A dual JAK3/TEC inhibitor, Litfulo (ritlecitinib) is approved for adults and adolescents over 12 years of ...