Blog
RSS FeedPosted 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
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 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 ...
Posted by Michael Wonder on 09 Dec 2018
Zaxine (rifaximin) - now indicated in Canada for patients with irritable bowel syndrome with diarrhoea
6 December 2018 - Lupin Pharma Canada is pleased to announce the approval from Health Canada for Zaxine 550 mg (rifaximin) ...
Posted by Michael Wonder on 06 Dec 2018
Ultragenyx and Kyowa Kirin announce Health Canada approval of Crysvita (burosumab injection) for the treatment of X–linked hypophosphataemia in adults and children
6 December 2018 - First approved treatment for XLH in Canada that targets the underlying cause of this rare, hereditary, lifelong ...
Posted by Michael Wonder on 28 Nov 2018
Alimera Sciences announces Canadian regulatory approval for Iluvien
26 November 2018 - Alimera Sciences today announced that Health Canada has approved Iluvien for the treatment of diabetic macular oedema. ...
Posted by Michael Wonder on 28 Nov 2018
Health Canada has now authorised Adynovate [anti-haemophilic factor (recombinant), PEGylated] in paediatrics for treatment of children under 12 with haemophilia A
26 November 2018 - Canadian children now have access to Adynovate, which offers a twice-weekly prophylaxis dosing schedule and on-demand control ...
Posted by Michael Wonder on 24 Nov 2018
Indivior announces Health Canada approval of Sublocade (buprenorphine extended release) injection for patients with moderate to severe opioid use disorder
23 November 2018 - Sublocade is the first and only once-monthly injectable buprenorphine formulation approved in Canada for the management of ...
Posted by Michael Wonder on 15 Nov 2018
Inclusion of data on treatment discontinuation in the Tasigna product monograph approved by Health Canada for CML patients who achieve a sustained molecular response
13 November 2018 - Approval is based on two studies showing more than half of patients remained in remission after stopping ...
Posted by Michael Wonder on 02 Nov 2018
Servier receives Health Canada approval of Folotyn for the treatment of relapsed or refractory peripheral T-cell lymphoma
1 November 2018 - Servier Canada announced that Health Canada granted a Notice of Compliance with conditions for Folotyn (pralatrexate) for ...
Posted by Michael Wonder on 01 Nov 2018
Novartis receives Health Canada approval for the combination therapy of Tafinlar (dabrafenib) plus Mekinist (trametinib) for adjuvant treatment of patients with BRAF V600 mutation melanoma
1 November 2018 - First approval in Canada of an adjuvant treatment for melanoma (BRAF V600 mutated). ...
Posted by Michael Wonder on 26 Oct 2018
Bayer receives approval for haemophilia A treatment Jivi
24 October 2018 - Extended half-life product that offers a reduction in dosing frequency and improved bleeding protection. ...
Posted by Michael Wonder on 18 Oct 2018
Health Canada has approved Invokana (canagliflozin) for reduction of major adverse cardiovascular events, the first SGLT2 inhibitor in Canada to receive this indication
17 October 2018 - Invokana has been shown to reduce the combined risk of cardiovascular death, non-fatal myocardial infarction and ...
Posted by Michael Wonder on 17 Oct 2018
Health Canada approves Xermelo (telotristat ethyl) for the treatment of adult patients suffering from refractory carcinoid syndrome diarrhea
16 October 2018 - Xermelo is a first-in-class treatment option for patients whose refractory carcinoid syndrome diarrhoea is inadequately controlled with ...