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RSS FeedPosted 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 ...
Posted by Michael Wonder on 15 Jan 2019
Valeo Pharma and Zambon announce the approval of Onstryv (safinamide) for Canada
15 January 2019 - New treatment option for estimated 100,000 Canadians living with Parkinson's disease. ...
Posted by Michael Wonder on 15 Jan 2019
Health Canada restricts Allergan's Esmya
15 January 2019 - Health Canada has placed restrictions on Allergan's uterine fibroid treatment Esmya, after discovering a possible link ...
Posted by Michael Wonder on 15 Jan 2019
Health Canada approves Xtandi (enzalutamide) - the first and only oral treatment for men with non-metastatic and metastatic castration-resistant prostate cancer
14 January 2019 - Astellas today announced that Health Canada approved an expanded indication for enzalutamide, an androgen receptor inhibitor for ...
Posted by Michael Wonder on 04 Jan 2019
Bausch & Lomb announces Health Canada approval of Vyzulta (latanoprostene bunod ophthalmic solution, 0.024%) for the treatment of glaucoma
3 January 2019 - Bausch & Lomb today announced that on 27 December 2018, Health Canada issued the notice of compliance ...
Posted by Michael Wonder on 18 Dec 2018
Cipher Pharmaceuticals announces A-101 40% topical solution accepted for review by Health Canada
18 December 2018 - Cipher Pharmaceuticals today announced that its new drug submission for A-101 40% topical solution ("A-101 40%") ...
Posted by Michael Wonder on 18 Dec 2018
Cipher Pharmaceuticals announces plecanatide accepted for review by Health Canada
17 December 2018 - Cipher Pharmaceuticals today announced that its new drug submission for plecanatide for irritable bowel syndrome with ...
Posted by Michael Wonder on 18 Dec 2018
Emergent BioSolutions receives Health Canada approval of BioThrax (anthrax vaccine adsorbed)
17 December 2018 - Emergent BioSolutions today announced that Health Canada has approved the company’s new drug submission for its anthrax ...
Posted by Michael Wonder on 17 Dec 2018
Health Canada approves Darzalex (daratumumab) for newly diagnosed patients with multiple myeloma who are transplant ineligible
17 December 2018 - Darzalex combination therapy significantly reduced the risk of disease progression or death compared to a preferred regimen ...
Posted by Michael Wonder on 14 Dec 2018
Health Canada grants market authorisation for Orkambi (lumacaftor/ivacaftor) for children with cystic fibrosis aged 2 to 5 years old with most common form of the disease
13 December 2018 - Orkambi is the first medicine in Canada to treat the underlying cause of cystic fibrosis in young ...