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RSS FeedPosted by Michael Wonder on 11 Mar 2019
Imbruvica (ibrutinib) combination regimen to treat Waldenström's macroglobulinemia approved through Health Canada priority review
8 March 2019 - Imbruvica plus rituximab showed significant improvement in progression-free survival versus rituximab monotherapy in Waldenström's macroglobulinemia, a ...
Posted by Michael Wonder on 05 Mar 2019
Recordati Rare Diseases Canada announces Health Canada approval of Cystadrops (cysteamine ophthalmic solution) for cystinosis patients
4 March 2019 - Recordati Rare Diseases Canada today announced the approval of Cystadrops, the first cysteamine solution approved by Health ...
Posted by Michael Wonder on 02 Mar 2019
Health Canada and CADTH launch new initiative to provide early parallel scientific advice
1 March 2019 - CADTH is pleased to announce a new collaboration with Health Canada and the Institut national d'excellence en ...
Posted by Michael Wonder on 01 Mar 2019
Patient access to cost-effective treatments increased with launch of new biosimilar in Canada
28 February 2019 - First-ever pegfilgrastim biosimilar approved by Health Canada launches across the country. ...
Posted by Michael Wonder on 25 Feb 2019
Health Canada approves Otsuka and Lundbeck's Rexulti (brexpiprazole) as adjunctive treatment of major depressive disorder
22 February 2019 - Otsuka and Lundbeck announce that Health Canada issued a Notice of Compliance for Rexulti (brexpiprazole) for ...
Posted by Michael Wonder on 24 Feb 2019
Paladin Labs announces approval of Envarsus PA (tacrolimus prolonged-release tablets) in Canada
22 February 2019 - Paladin Labs and Endo today announced Health Canada's approval of Envarsus PA (tacrolimus prolonged-release tablets) for ...
Posted by Michael Wonder on 21 Feb 2019
AbbVie's Humira (adalimumab) approved by Health Canada to treat paediatric patients with chronic non-infectious anterior uveitis
20 February 2019 - The approval marks Humira as the only approved biologic treatment option in Canada for paediatric patients from ...
Posted by Michael Wonder on 20 Feb 2019
Diverging from FDA, Health Canada announces suffix-free biologic and biosimilar naming convention
18 February 2019 - Health Canada has announced that all biologics, including biosimilars, will be identified by their brand names and ...
Posted by Michael Wonder on 20 Feb 2019
Gilead receives approval in Canada for Yescarta (axicabtagene ciloleucel) CAR T therapy for adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy
19 February 2019 - Yescarta is a chimeric antigen receptor T-cell therapy that is custom-made for each patient from his or ...
Posted by Michael Wonder on 12 Feb 2019
Health Canada issues Notice of Compliance with Conditions for Idhifa the first oral targeted therapy for adult patients with relapsed or refractory acute myeloid leukaemia and an IDH2 mutation
11 February 2019 - Conditional approval validates Idhifa as the first and only oral, targeted inhibitor of IDH2. ...
Posted by Michael Wonder on 08 Feb 2019
Advanced Accelerator Applications announces Health Canada approval for Lutathera, a treatment for gastro-enteropancreatic neuroendocrine tumours
7 February 2019 - First ever approved peptide receptor radionuclide therapy in Canada. ...
Posted by Michael Wonder on 29 Jan 2019
Health Canada grants market authorisation for Kalydeco (ivacaftor) in children ages 12 to <24 months with certain mutations in the CFTR gene
28 January 2019 - Kalydeco is the first and only approved medicine in Canada to treat the underlying cause of ...
Posted by Michael Wonder on 27 Jan 2019
Tanvex submits new drug submission for TX01 to Health Canada
Posted by Michael Wonder on 26 Jan 2019
Acerus receives Notice of Deficiency-withdrawal letter from Health Canada regarding Gynoflor application
25 January 2019 - Acerus Pharmaceuticals is today advising that it has received a Notice of Deficiency-Withdrawal Letter for its ...
Posted by Michael Wonder on 22 Jan 2019
Sandoz Canada receives Health Canada approval for Erelzi (etanercept) in the treatment of psoriatic arthritis in adult patients
21 January 2019 - Erelzi is the only etanercept biosimilar to be indicated for reducing the signs and symptoms of psoriatic ...