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RSS FeedPosted by Michael Wonder on 10 May 2023
Health Canada Approves AbbVie's Rinvoq (upadacitinib) for the Treatment of Adults with Active Non-Radiographic Axial Spondyloarthritis
9 May 2023 - Approval is based on results from the Phase 3 SELECT-AXIS 2 pivotal clinical trial in which Rinvoq ...
Posted by Michael Wonder on 09 May 2023
Rhythm Pharmaceuticals announces Health Canada approval of Imcivree setmelanotide injection for weight management in Bardet-Biedl syndrome or genetically-confirmed biallelic POMC, PCSK1, or LEPR deficiency
8 May 2023 - Approval granted following a priority review by Health Canada. ...
Posted by Michael Wonder on 05 May 2023
Dupixent (dupilumab injection) is now approved in Canada for the treatment of adult and adolescent patients (12+) with eosinophilic esophagitis
4 May 2023 - This is the eighth indication for Dupixent in Canada and its first in gastroenterology. ...
Posted by Michael Wonder on 04 May 2023
Health Canada approves Quviviq (daridorexant) for the management of adult patients with insomnia
3 May 2023 - Quviviq is indicated for the management of adult patients with insomnia, characterized by difficulties with sleep onset ...
Posted by Michael Wonder on 02 May 2023
Libtayo (cemiplimab) in combination with chemotherapy now approved in Canada for the first-line treatment of advanced non-small cell lung cancer
1 May 2023 - Approval marks second first-line indication in NSCLC and fifth indication for Libtayo in Canada. ...
Posted by Michael Wonder on 29 Apr 2023
Arcutis announces Canadian approval of Zoryve (roflumilast) cream 0.3% for treatment of plaque psoriasis in individuals 12 years and older
28 April 2023 - First Zoryve approval outside of the US marks key milestone for Arcutis. ...
Posted by Michael Wonder on 24 Apr 2023
Health Canada approves new antibody drug to help prevent serious RSV in babies
22 April 2023 - Health Canada has approved a new antibody drug to help protect babies from serious illness caused ...
Posted by Michael Wonder on 18 Apr 2023
Health Canada approves Alhemo, the first subcutaneous prophylactic treatment for people living with haemophilia B with inhibitors
17 April 2023 - New treatment option for Canadians living with rare and serious X-chromosome linked congenital bleeding disorder ...
Posted by Michael Wonder on 13 Apr 2023
Vertex announces Health Canada market authorisation for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 1 to <2 years
10 April 2023 - With this approval, approximately 30 children with two copies of the F508del mutation are eligible for ...
Posted by Michael Wonder on 04 Apr 2023
Chiesi Global Rare Diseases announces approval of Ferriprox MR deferiprone extended release tablets in Canada
31 March 2023 - New formulation allows twice-daily dosing in patients with transfusional iron overload due to thalassaemia syndromes when ...
Posted by Michael Wonder on 27 Mar 2023
Kite's Yescarta (axicabtagene ciloleucel) first CAR T-cell therapy to receive Health Canada authorisation for use in second-line large B-cell lymphoma
23 March 2023 - Landmark ZUMA-7 study demonstrated patients on Yescarta were 2.5 times more likely to be alive at ...
Posted by Michael Wonder on 27 Mar 2023
Health Canada authorises Imbruvica (ibrutinib) in a fixed duration combination with venetoclax for adult patients with previously untreated chronic lymphocytic leukaemia
23 March 2023 - All oral, once daily, fixed duration combination regimen authorised for first-line treatment of CLL. ...
Posted by Michael Wonder on 27 Mar 2023
Columvi (glofitamab for injection) receives Health Canada authorisation with conditions for adult patients with relapsed or refractory diffuse large B-cell lymphoma
25 March 2023 - Authorization is based on results from the Phase 1/2 NP30179 study, which demonstrated Columvi induced durable response ...
Posted by Michael Wonder on 27 Mar 2023
Health Canada approves first treatment option for generalised pustular psoriasis flares in adults
24 March 2023 - In the EFFISAYIL-1 trial, over half of the Spevigo (spesolimab) treated patients were free of pustules, ...
Posted by Michael Wonder on 19 Feb 2023
Health Canada authorises Moderna's Omicron targeting bivalent COVID-19 vaccine in children & adolescents (6-17 years)
17 February 2023 - The recommendation is based on clinical data for Moderna's bivalent Omicron targeting COVID-19 vaccine, mRNA.1273.214. ...