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RSS FeedPosted 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
Sudbury, Ontario family finally gets coverage for drug to treat daughter's rare epilepsy
16 January 2024 - Fenfluramine costs more than $3,000 a month and is not approved by Health Canada. ...
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 10 Jan 2024
AARP statement on FDA’s prescription drugs importation approval for Florida
8 January 2024 - AARP Executive Vice President and Chief Advocacy and Engagement Officer Nancy LeaMond issued the following statement ...
Posted by Michael Wonder on 08 Jan 2024
Florida is first state allowed to import drugs from Canada in bid to reduce costs
5 January 2024 - FDA’s decision could change the way Americans obtain prescription medicines. ...
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 22 Dec 2023
Keytruda (pembrolizumab) plus Lenvima (lenvatinib) receive public listing for patients with advanced endometrial carcinoma that is not MSI-H or dMMR
21 December 2023 - Merck and Eisai announce that Keytruda plus Lenvima, is now reimbursed with clinical criteria and conditions ...
Posted by Michael Wonder on 19 Dec 2023
The Government of Canada announces the creation of the Canadian Drug Agency
18 December 2023 - Helping make Canada's drug system more sustainable and better prepared for the future. ...
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. ...