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RSS FeedPosted by Michael Wonder on 16 Jul 2025
Health Canada approves Lilly's Omvoh (mirikizumab) for Crohn's disease; new citrate-free formulation
15 July 2025 - Eli Lilly Canada announced today that Health Canada has approved Omvoh (mirikizumab) for Crohn's disease, which will ...
Posted by Michael Wonder on 15 Jul 2025
Health Canada extends the approval of Evkeeza (evinacumab) to children as young as 6 months old with homozygous familial hypercholesterolaemia
14 July 2025 - Ultragenyx today announced that Health Canada has extended the approval of Evkeeza (evinacumab) as an adjunct to ...
Posted by Michael Wonder on 03 Jul 2025
Apotex receives Health Canada approval for Aflivu, a biosimilar to Eylea, available in pre-filled syringe and vial formats
2 July 2025 - Apotex today announced that Health Canada has approved Aflivu (aflibercept), a biosimilar to Eylea, indicated for ...
Posted by Michael Wonder on 28 Jun 2025
Biocon Biologics receives Health Canada approval for Yesafili (aflibercept); first global launch scheduled for July 2025
27 June 2025 - Biocon Biologics is pleased to announce that Health Canada has granted a Notice of Compliance for Yesafili ...
Posted by Michael Wonder on 19 Jun 2025
Kye Pharmaceuticals receives Health Canada approval for new dosing guidance for Firdapse and an additional paediatric indication
17 June 2025 - Kye Pharmaceuticals today announced that Health Canada has approved its supplemental new drug submission regarding the recommended ...
Posted by Michael Wonder on 19 Jun 2025
Health Canada approves Novartis' Kisqali for HR positive, HER2 negative early breast cancer patients at high risk of recurrence
18 June 2025 - Health Canada approval is based on the pivotal Phase 3 NATALEE trial data, which demonstrated a clinically ...
Posted by Michael Wonder on 17 Jun 2025
Vanflyta is now approved in Canada specifically for adult patients with newly diagnosed FLT3-ITD positive AML
16 June 2025 - Approval based on QuANTUM-First results demonstrating Vanflyta added to chemotherapy improved overall survival ...
Posted by Michael Wonder on 14 Jun 2025
Xediton Pharmaceuticals announced today the Canadian approval and availability of Vabomere (meropenem-vaborbactam) in Canada
12 June 2025 - Xediton Pharmaceuticals is proud to announce that Vabomere (meropenem-vaborbactam) has been approved by Health Canada and ...
Posted by Michael Wonder on 12 Jun 2025
Health Canada authorises PiaSky (crovalimab for injection) as the first monthly (every four weeks) subcutaneous treatment for people with paroxysmal nocturnal haemoglobinuria
11 June 2025 - Roche Canada is pleased to announce that Health Canada has authorised PiaSky (crovalimab for injection) as ...
Posted by Michael Wonder on 06 Jun 2025
Merz Aesthetics receives approval from Health Canada for Radiesse as an aesthetic injectable for the treatment of moderate wrinkles in the décolleté area
5 June 2025 - Merz Aesthetics Canada announced today the Health Canada approval for Radiesse for the treatment of moderate ...
Posted by Michael Wonder on 02 Jun 2025
Enhertu (trastuzumab deruxtecan) receives time limited reimbursement recommendation from Canada's Drug Agency for gastric cancer
23 May 2025 - AstraZeneca and Daiichi Sankyo are pleased to announce that Canada's Drug Agency has issued a time-limited reimbursement ...
Posted by Michael Wonder on 28 May 2025
New subcutaneous formulation of Opdivo approved in Canada for use across all authorised solid tumour indications
27 May 2025 - Subcutaneous option of established immunotherapy offers potential to reduce time in clinic and ease infusion burden. ...
Posted by Michael Wonder on 22 May 2025
Tagrisso approved (with conditions) in Canada for patients with unresectable, stage III EGFR-mutated non-small cell lung cancer
21 May 2025 - Based on LAURA Phase 3 trial results which showed patients who took Targrisso after CRT had ...
Posted by Michael Wonder on 09 May 2025
Itulatek approved for treatment of children and adolescents in Canada
8 May 2025 - ALK today announced that Health Canada has approved ALK’s regulatory filing for Itulatek (tree pollen sublingual allergy ...
Posted by Michael Wonder on 06 May 2025
Health Canada has granted approval for Tzield, the first and only disease-modifying therapy in auto-immune type 1 diabetes in Canada
5 May 2025 - Tzield is demonstrated to delay by a median of 2 years the onset of Stage 3 type ...