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RSS FeedPosted by Michael Wonder on 28 Mar 2022
Dupixent (dupilumab injection) now approved in Canada for the treatment of severe asthma in children aged six to 11 years with type 2 inflammation
28 March 2022 - This is the sixth indication for Dupixent in Canada, its second in asthma, and its second in ...
Posted by Michael Wonder on 28 Mar 2022
Health Canada grants marketing authorisation for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene
25 March 2022 - CNW/ - Vertex Pharmaceuticals Canada today announced that Health Canada has granted marketing authorisation for the ...
Posted by Michael Wonder on 22 Mar 2022
KYE Pharmaceuticals files Accrufer new drug submission in Canada for the treatment of iron deficiency
21 March 2022 - Shield Therapeutics announces that KYE Pharmaceuticals has submitted a new drug submission to Health Canada for ...
Posted by Michael Wonder on 20 Mar 2022
AbbVie expands immunology portfolio in Canada as Health Canada approves Skyrizi (risankizumab) for the treatment of adults with active psoriatic arthritis
17 March 2022 - Approval supported by data from two Phase 3 studies evaluating Skyrizi in psoriatic arthritis patients, KEEPsAKE-1 ...
Posted by Michael Wonder on 19 Mar 2022
Heron Therapeutics announces approval of Zynrelef by Health Canada for the management of post-operative pain
17 March 2022 - ZYNRELEF is the first and only extended-release local anaesthetic approved by Health Canada. ...
Posted 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 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 ...