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RSS FeedPosted by Michael Wonder on 30 Nov 2024
Health Canada authorises Carvykti (ciltacabtagene autoleucel) for patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
21 November 2024 - Authorisation is based on results from the Phase 3 CARTITUDE-4 (MMY3002) study, which showed treatment with ...
Posted by Michael Wonder on 15 Nov 2024
Knight Therapeutics announces Health Canada approval for Jornay PM to treat attention deficit hyperactivity disorder
14 November 2024 - Knight Therapeutics announced today that Health Canada has approved Jornay PM, an extended-release formulation of methylphenidate, a ...
Posted by Michael Wonder on 13 Nov 2024
Ojjaara (momelotinib) approved in Canada for the treatment of myelofibrosis in adults who have moderate to severe anaemia
12 November 2024 - Ojjaara (momelotinib) is the only approved treatment for newly diagnosed and previously treated myelofibrosis patients who have ...
Posted by Michael Wonder on 09 Nov 2024
Moderna receives Health Canada approval for RSV vaccine for adults aged 60 years and older
8 November 2024 - mRESVIA is Moderna's second approved product in Canada, the first mRNA vaccine against RSV, and the only ...
Posted by Michael Wonder on 06 Nov 2024
Expanded age indication for GSK's Arexvy, the first respiratory syncytial virus vaccine approved in Canada for adults aged 50-59 at increased risk
5 November 2024 - Clinical development program continues to evaluate safety and immunogenicity in adults aged 18-49 at increased risk ...
Posted 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 ...