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RSS FeedPosted by Michael Wonder on 07 Dec 2019
International collaboration among Canadian, U.S. and Australian regulators leads to new options for the treatment of cancer
6 December 2019 - Health Canada also provides an update on approvals of new drugs and medical devices for Canadians. ...
Posted by Michael Wonder on 04 Dec 2019
Health Canada grants priority review status for Heron Therapeutics' new drug submission for HTX-011 for management of post-operative pain
3 December 2019 - Heron Therapeutics today announced that Heron's new drug submission for HTX-011 for the management of postoperative pain ...
Posted by Michael Wonder on 28 Nov 2019
Health Canada approves Ofev (nintedanib), the first and only therapy in Canada to slow the rate of decline in pulmonary function in patients with systemic sclerosis associated ILD
27 November 2019 - Boehringer Ingelheim announced today that Health Canada has approved Ofev (nintedanib) as the first and only treatment ...
Posted by Michael Wonder on 26 Nov 2019
Seattle Genetics announces Health Canada approval of Adcetris (brentuximab vedotin) in combination with chemotherapy in frontline CD30-expressing peripheral T-cell lymphoma
25 November 2019 - Approval of supplemental new drug aubmission for Adcetris in combination with CHP chemotherapy in frontline CD30-expressing peripheral ...
Posted by Michael Wonder on 22 Nov 2019
Health Canada approves Lonsurf (trifluridine/tipiracil) for adults with metastatic gastric cancer during stomach cancer awareness month
21 November 2019 - New indication improves overall survival for end stage metastatic disease ...
Posted by Michael Wonder on 21 Nov 2019
FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukaemia
21 November 2019 - Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, ...
Posted by Michael Wonder on 20 Nov 2019
Medexus granted priority review status for Gliolan by Health Canada
19 November 2019 - Medexus Pharmaceuticals today announced that Health Canada has granted priority review status for the new drug ...
Posted by Michael Wonder on 15 Nov 2019
Valeo Pharma announces filing of a new drug submission for low molecular weight heparin in Canada
14 November 2019 - Valeo Pharma announced today that the new drug submission filed for a low molecular weight heparin ...
Posted by Michael Wonder on 13 Nov 2019
Exelixis’ partner Ipsen announces Health Canada’s approval of Cabometyx (cabozantinib) tablets for the treatment of patients with previously treated advanced hepatocellular carcinoma
12 November 2019 - Approval based on statistically significant and clinically meaningful overall survival benefit demonstrated in the CELESTIAL phase 3 ...
Posted by Michael Wonder on 09 Nov 2019
Xeomin Cosmetic licensed for additional indications In Canada
7 November 2019 - Merz Pharma has announced that Health Canada has provided marketing authorization for additional indications for Xeomin ...
Posted by Michael Wonder on 09 Nov 2019
Janssen announces Health Canada approval of Imbruvica (ibrutinib) in combination with obinutuzumab for treatment naïve patients with chronic lymphocytic leukaemia
8 November 2019 - Patients experienced a 77% reduction in risk of disease progression or death compared to chlorambucil plus obinutuzumab. ...
Posted by Michael Wonder on 07 Nov 2019
Endoceutics receives Health Canada approval for Intrarosa
6 November 2019 - The first innovative drug for the treatment of vulvovaginal atrophy with prasterone. ...
Posted by Michael Wonder on 31 Oct 2019
Janssen announces Health Canada approval of Darzalex (daratumumab) in combination with lenalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are transplant ineligible
30 October 2019 - This Darzalex combination regimen reduced the risk of disease progression or death by 44% in newly ...
Posted by Michael Wonder on 24 Oct 2019
Knight Therapeutics and SIFI announce approval of Netildex in Canada
23 October 2019 - Knight Therapeutics and SIFI today announced that Health Canada has approved Netildex for the treatment of inflammatory ...
Posted by Michael Wonder on 21 Oct 2019
Bausch Health announces updated Health Canada safety information for Elidel
17 October 2019 - Topical atopic dermatitis treatment Elidel now available for children three months and over. ...