Blog
RSS FeedPosted by Michael Wonder on 12 Mar 2022
Catalyst Pharmaceuticals and KYE Pharmaceuticals announce a second favourable Canadian Federal Court ruling setting aside approval of Ruzurgi
11 March 2022 - Catalyst Pharmaceuticals and KYE Pharmaceuticals today announced receipt of a favourable decision from the Federal Court of ...
Posted by Michael Wonder on 10 Mar 2022
Health Canada approves Samsung Bioepis and Biogen’s Byooviz (SB11), Lucentis biosimilar (ranibizumab)
10 March 2022 - Byooviz becomes the first Lucentis biosimilar to be approved in Canada following its approval in Europe and ...
Posted by Michael Wonder on 04 Mar 2022
BeiGene announces Health Canada approval for Brukinsa (zanubrutinib) in relapsed or refractory marginal zone lymphoma
3 March 2022 - Third approved indication for Brukinsa in Canada, following mantle cell lymphoma and Waldenström’s macroglobulinaemia. ...
Posted by Michael Wonder on 27 Feb 2022
Health Canada authorises Medicago COVID-19 vaccine for adults 18 to 64 years of age
25 February 2022 - Today, Health Canada authorised Medicago's Covifenz COVID-19 vaccine for the prevention of COVID-19 in adults 18 to ...
Posted by Michael Wonder on 17 Feb 2022
Health Canada authorises Novavax's Nuvaxovid COVID-19 vaccine
17 February 2022 - Today, Health Canada authorised Novavax's Nuvaxovid COVID-19 vaccine for the prevention of COVID-19 in adults 18 years ...
Posted by Michael Wonder on 05 Feb 2022
Health Canada authorises Tecentriq (atezolizumab) for Canadians with early non-small cell lung cancer
4 February 2022 - Tecentriq (atezolizumab) is the first and only cancer immunotherapy approved for non-small cell lung cancer in the ...
Posted by Michael Wonder on 04 Feb 2022
Samsung Bioepis announces Health Canada approval of 150 mg single-use vial and 440 mg multi-dose vial of Ontruzant (SB3), trastuzumab biosimilar for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer
2 February 2022 - 150 mg and 440 mg vial of Ontruzant are now approved in Canada. ...
Posted by Michael Wonder on 01 Feb 2022
Celltrion Healthcare announces Canadian approval of Yuflyma, a high concentration, low volume, citrate free and latex free Humira (adalimumab) biosimilar
31 January 2022 - Yuflyma brings a new offering to healthcare practitioners and their patients with inflammatory diseases in Canada. ...
Posted by Michael Wonder on 31 Jan 2022
Health Canada authorises Verzenio (abemaciclib) as the first and only CDK4/6 inhibitor for patients with HR+ HER2- high risk early breast cancer
27 January 2022 - Adding Verzenio to endocrine therapy demonstrated a significant and clinically meaningful reduction in the risk of recurrence ...
Posted by Michael Wonder on 24 Jan 2022
Health Canada approves Ipsen’s Sohonos (palovarotene) as the first approved treatment for fibrodysplasia ossificans progressiva
24 January 2022 - Ipsen today announced the Health Canada approval of Sohonos (palovarotene), an oral selective retinoic-acid receptor gamma agonist ...
Posted by Michael Wonder on 18 Jan 2022
Canada approves Pfizer COVID drug
18 January 2022 - Canada’s health regulator has approved a pill by Pfizer that treats the effects of COVID-19. ...
Posted by Michael Wonder on 13 Jan 2022
JAMP and Alvotech announce Canadian approval of Simlandi, a high concentration biosimilar to Humira, providing access to previously unavailable versions in Canada
10 January 2021 - Health Canada rules that 40 mg/0.4 mL and 80 mg/0.8 mL presentations of Simlandi are not subject ...
Posted by Michael Wonder on 31 Dec 2021
Celltrion acquires approval for its new Humira 'Yuflyma' in Canada
30 December 2021 - Celltrion announced on December 30 that it won marketing approval from Health Canada for "Yuflyma", a ...
Posted by Michael Wonder on 26 Dec 2021
SIGA announces Health Canada regulatory approval of oral TPOXX
1 December 2021 - SIGA Technologies today announced that Health Canada has approved oral Tpoxx (tecovirimat) as an extraordinary use new ...
Posted by Michael Wonder on 26 Dec 2021
GSK’s Jemperli (dostarlimab for injection) approved in Canada as an anti-PD-1 therapy for recurrent or advanced endometrial cancer
15 December 2021 - GSK announces today that it has been granted Notice of Compliance with conditions for its endometrial ...