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RSS FeedPosted 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. ...
Posted by Michael Wonder on 11 Feb 2023
Health Canada approves Adtralza (tralokinumab) for the treatment of adolescents aged 12 to 17 with moderate to severe atopic dermatitis
8 February 2023 - Adtralza is the first treatment for adolescents with moderate to severe atopic dermatitis specifically targeting the ...
Posted by Michael Wonder on 18 Jan 2023
Ultomiris approved in Canada for adults with generalied myasthenia gravis
17 January 2023 - First and only long acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised ...
Posted by Michael Wonder on 17 Jan 2023
Celltrion gets nod from Canadian regulator for sales of Avastin biosimilar
17 January 2023 - Celltrion obtained permission from Health Canada to sell Avastin (bevacizumab) biosimilar Vegzelma (CT-P16) on Tuesday. ...
Posted by Michael Wonder on 13 Jan 2023
Enhertu approved by Health Canada as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
12 January 2023 - Approval based on the DESTINY-Breast04 results which showed Enhertu reduced risk of disease progression or death ...