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RSS FeedPosted 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 ...
Posted by Michael Wonder on 03 Dec 2023
Duchesnay is seeking Health Canada approval for a segesterone acetate/ethinyl estradiol contraceptive vaginal system, a new option for women
30 November 2023 - Duchesnay has recently filed a new drug submission to Health Canada for its segesterone acetate/ethinyl estradiol slow ...
Posted by Michael Wonder on 02 Dec 2023
Health Canada grants market authorisation for Kalydeco (ivacaftor) for eligible children with cystic fibrosis ages 2 months and older
29 November 2023 - Vertex Pharmaceuticals today announced that Health Canada has granted market authorisation for the expanded use of ...
Posted by Michael Wonder on 25 Nov 2023
Jazz Pharmaceuticals receives Health Canada approval for Epidiolex (cannabidiol oral solution) for the treatment of seizures associated with three rare forms of epilepsy
23 November 2023 - Jazz Pharmaceuticals Canada today announced that Epidiolex (cannabidiol oral solution), has been approved by Health Canada ...
Posted by Michael Wonder on 17 Nov 2023
Jemperli (dostarlimab for injection) plus carboplatin and paclitaxel approved in Canada as a treatment option for primary advanced or recurrent dMMR/MSI-H endometrial cancer
16 November 2023 - Jemperli is the only immuno-oncology treatment approved for this patient population in combination with chemotherapy in Canada. ...
Posted by Michael Wonder on 14 Nov 2023
Ipsen and Medison Pharma announce Health Canada approval of Bylvay (odevixibat) for the treatment of pruritus due to progressive familial intrahepatic cholestasis
13 November 2023 - Bylvay (odevixibat) is the first and only oral treatment available in Canada for the treatment of ...
Posted by Michael Wonder on 07 Nov 2023
Health Canada approves Doptelet (avatrombopag) for two indications in thrombocytopenia
6 November 2023 - Doptelet is the only oral thrombopoietin receptor agonist without food-type restrictions or significant hepatotoxicity. ...