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RSS FeedPosted by Michael Wonder on 23 Oct 2024
Health Canada approves first and only oral targeted treatment for brain cancer
22 October 2024 - Pivotal Phase 3 study shows significant improvement in progression-free survival with a favourable safety profile. ...
Posted by Michael Wonder on 19 Oct 2024
Arcutis announces Health Canada approval of Zoryve (roflumilast) foam 0.3% to treat seborrheic dermatitis in individuals 9 years of age and older
18 October 2024 - Zoryve foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved ...
Posted by Michael Wonder on 18 Oct 2024
Fresenius Kabi launches Tyenne, the first and only approved tocilizumab biosimilar in Canada
17 October 2024 - Tyenne is the first and only tocilizumab biosimilar to be launched in Canada. ...
Posted by Michael Wonder on 17 Oct 2024
Incyte announces Health Canada approval of Opzelura (ruxolitinib) cream for the treatment of atopic dermatitis and non-segmental vitiligo
16 October 2024 - First and only treatment approved by Health Canada for repigmentation of non-segmental vitiligo. ...
Posted by Michael Wonder on 17 Oct 2024
Acadia Pharmaceuticals announces Health Canada approval of Daybue (trofinetide) for the treatment of Rett syndrome
16 October 2024 - Daybue is the first and only therapy approved in Canada for the treatment of Rett syndrome, a ...
Posted by Michael Wonder on 07 Oct 2024
Health Canada approves label expansion for Telix’s Illuccix to include patient selection for PSMA targeted therapy
4 October 2024 - Telix Pharmaceuticals today announces that Health Canada has approved the use of Illuccix (kit for the ...
Posted by Michael Wonder on 02 Oct 2024
Clinuvel files Canadian new drug submission for Scenesse in EPP
30 September 2024 - Patient special access program continues during Health Canada review. ...
Posted by Michael Wonder on 29 Sep 2024
Vertex announces Health Canada acceptance of new drug submission for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis
26 September 2024 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review its new drug submission for ...
Posted by Michael Wonder on 26 Sep 2024
Health Canada grants marketing authorisation of first CRISPR/Cas9 gene edited therapy, Casgevy (exagamglogene autotemcel), for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
25 September 2024 - First regulatory authorisation of a CRISPR-based gene-editing therapy in Canada. ...
Posted by Michael Wonder on 26 Sep 2024
Pfizer Canada and BioNTech receive Health Canada approval of Omicron KP.2 variant adapted COVID-19 vaccine
24 September 2024 - Omicron KP.2 variant adapted vaccine Comirnaty is now authorised in Canada for individuals 6 months of age ...
Posted by Michael Wonder on 25 Sep 2024
Moderna receives Health Canada approval for updated COVID-19 vaccine targeting KP.2 variant of SARS-COV-2 for ages six months and older
17 September 2024 - Spikevax is the first updated COVID-19 vaccine authorised in Canada for 2024-2025, offering a timely solution to ...
Posted by Michael Wonder on 21 Sep 2024
New COVID-19 vaccine by Moderna approved by Health Canada
17 September 2024 - Health Canada has approved an updated version of Moderna’s COVID-19 vaccine, a decision that means some ...
Posted by Michael Wonder on 19 Sep 2024
Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada
18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...
Posted by Michael Wonder on 18 Sep 2024
Biogen's new drug submission for omaveloxolone accepted for priority review by Health Canada for the treatment of Friedreich's ataxia
17 September 2024 - If approved, omaveloxolone would be the only disease specific treatment option for patients living with this progressive ...
Posted by Michael Wonder on 13 Sep 2024
Dupixent (dupilumab injection) approved in Canada for the treatment of children aged 1 year and older with eosinophilic oesophagitis
12 September 2024 - This is the ninth indication for Dupixent in Canada and its second in gastroenterology. ...