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RSS FeedPosted by Michael Wonder on 15 Apr 2023
Pfizer Canada initiates submission to Health Canada for its bivalent respiratory syncytial virus vaccine
14 April 2023 - Indications under review include prevention of respiratory syncytial virus in infants from birth through 6 months ...
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
Koselugo approved in Canada for paediatric patients with neurofibromatosis type 1 plexiform neurofibromas
3 April 2023 - First and only therapy approved to treat this rare and debilitating genetic condition. ...
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 09 Mar 2023
Samsung Bioepis launches Lucentis biosimilar in Canada, Germany
5 March 2023 - According to industry sources on Sunday, SB11 was introduced to the Canadian market last Wednesday through its ...
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 13 Feb 2023
Mitsubishi Tanabe Pharma Canada announces Radicava (edaravone) oral suspension is now available in Canada for the treatment of patients with ALS
10 February 2023 - Mitsubishi Tanabe Pharma Canada today announced that Radicava oral suspension, the oral formulation of Radicava IV ...
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 27 Jan 2023
Valeo Pharma announces filing of a new drug submission with Health Canada for sabizabulin for the treatment of hospitalised COVID-19 patients
26 January 2023 - In the final analysis of the Phase 3 clinical study conducted by Veru, sabizabulin showed a 51.6% ...
Posted by Michael Wonder on 19 Jan 2023
Health Canada accepts nirsevimab regulatory submission for infant RSV
18 January 2023 - Nirsevimab is the first investigational long-acting antibody designed for all infants to help protect against respiratory syncytial ...
Posted by Michael Wonder on 18 Jan 2023
Medunik Canada obtains new Notice of Compliance from Health Canada for Ruzurgi (amifampridine) following a favourable Canadian Federal Court of Appeal ruling
17 January 2023 - Medunik Canada is pleased to announce that on 9 January 2023, the Federal Court of Appeal of ...