Blog
RSS FeedPosted 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. ...
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 30 Nov 2023
Prevalence and nature of manufacturer-sponsored patient support programs for prescription drugs in Canada: a cross-sectional study
27 November 2023 - Of the 2556 prescription drugs marketed by 89 companies in the study period, 256 (10.0%) had a ...
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 23 Nov 2023
AnHeart Therapeutics and Innovent announce China’s NMPA has accepted a new drug application for taletrectinib (ROS1 inhibitor)
22 November 2023 - AnHeart Therapeutics and Innovent Biologics today announced that the Center for Drug Evaluation of China’s NMPA ...
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. ...