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RSS FeedPosted 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 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 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 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. ...
Posted by Michael Wonder on 02 Nov 2023
Health Canada approves Ultomiris for adults with neuromyelitis optica spectrum disorder
1 November 2023 - Ultomiris transforms the treatment landscape for anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder patients, with potential to ...
Posted by Michael Wonder on 27 Oct 2023
Health Canada authorises CSL's Hemgenix (etranacogene dezaparvovec) as first gene therapy for haemophilia B
26 October 2023 - CSL's Hemgenix is a one time, single dose treatment for adults with haemophilia B who require ...