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RSS FeedPosted by Michael Wonder on 22 Sep 2020
Knight and TherapeuticsMD announce Health Canada approval of Bijuva
21 September 2020 - Knight Therapeutics and TherapeuticsMD announced today the approval of Bijuva (estradiol and progesterone) capsules by Health ...
Posted by Michael Wonder on 16 Sep 2020
Brenzys (etanercept injection) now indicated for the treatment of plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis
15 September 2020 - Brenzys is a biosimilar biologic drug authorised based on its similarity to Enbrel, which is already approved ...
Posted by Michael Wonder on 11 Sep 2020
Health Canada approves Tremfya (guselkumab injection), a first in class, selective interleukin 23 inhibitor for active psoriatic arthritis
10 September 2020 - Data show Tremfya significantly improved signs and symptoms in joints, skin, and soft tissue of adults with ...
Posted by Michael Wonder on 11 Sep 2020
Medexus reports Health Canada approval of Gleolan for use in guided surgical resection of high grade gliomas
10 September 2020 - Medexus Pharmaceuticals today announces that on 9 September 2020, it received a Notice of Compliance from ...
Posted by Michael Wonder on 10 Sep 2020
BeiGene announces acceptance and priority review by Health Canada of new drug submission for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
9 September 2020 - BeiGene today announced that its new drug submission for Brukinsa (zanubrutinib) for the treatment of patients with ...
Posted by Michael Wonder on 01 Sep 2020
Health Canada authorises Enspryng for Canadians living with neuromyelitis optica spectrum disorder
31 August 2020 - Roche Canada announced today that Health Canada has granted market authorisation for Enspryng (satralizumab) as monotherapy ...
Posted by Michael Wonder on 27 Aug 2020
KYE Pharmaceuticals and Catalyst Pharmaceuticals challenge Health Canada’s decision to overlook Firdapse data exclusivity
26 August 2020 - Catalyst Pharmaceuticals and KYE Pharmaceuticals today announced the filing of a proceeding in Canadian Federal Court ...
Posted by Michael Wonder on 26 Aug 2020
Catalyst takes its fight over a rare disease drug to Canada, suing the country’s regulator
26 August 2020 - In unusual battle between two small companies over the market for a rare disease drug has ...
Posted by Michael Wonder on 26 Aug 2020
Cystic fibrosis drug could reduce severe disease, deaths if made available to Canadians
25 August 2020 - Talia D’Alessio has been living with cystic fibrosis since she was nine months old. ...
Posted by Michael Wonder on 26 Aug 2020
Knight and TherapeuticsMD announce Health Canada approval of Imvexxy
25 August 2020 - Knight Therapeutics and TherapeuticsMD announced today the approval of Imvexxy by Health Canada. In Canada, Imvexxy is ...
Posted by Michael Wonder on 20 Aug 2020
Health Canada grants market authorization for Tecentriq in combination with bevacizumab, the first immunotherapy combination treatment, for the most common form of liver cancer
19 August 2020 - Tecentriq in combination with bevacizumab improved overall survival and progression-free survival compared to the previous standard of ...
Posted by Michael Wonder on 19 Aug 2020
Dupixent (dupilumab injection) now approved by Health Canada for severe chronic rhinosinusitis with nasal polyposis
18 August 2020 - First biologic approved in Canada for adults with severe chronic rhinosinusitis with nasal polyposis. ...
Posted by Michael Wonder on 16 Aug 2020
Piqray is approved and now available in Canada as the first and only treatment specifically for patients with a PIK3CA mutation in HR positive, HER2 negative advanced breast cancer
13 August 2020 - Approval is based on results from SOLAR-1, where Piqray in combination with fulvestrant nearly doubled median progression-free ...
Posted by Michael Wonder on 13 Aug 2020
Elusys Therapeutics receives Health Canada approval for Anthim for the treatment of inhalation anthrax
12 August 2020 - Elusys Therapeutics today announced that Health Canada has approved the company's new drug submission for Anthim ...
Posted by Michael Wonder on 12 Aug 2020
Health Canada approves Opdivo (nivolumab) plus Yervoy (ipilimumab) combined with limited chemotherapy for the treatment of metastatic non-small cell lung cancer
11 August 2020 - CheckMate-9LA trial results demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumour histology. ...