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RSS FeedPosted by Michael Wonder on 06 Feb 2026
Merck announces Health Canada approval of Enflonsia for the prevention of RSV in newborns and infants
5 February 2026 - Approval is based on the CLEVER and SMART clinical trial results. ...
Posted by Michael Wonder on 03 Feb 2026
Jaypirca (pirtobrutinib), the first and only non-covalent (reversible) BTK inhibitor, now available in Canada for adult patients with relapsed or refractory mantle cell lymphoma and chronic lymphocytic leukaemia
27 January 2026 - The approval of Jaypirca marks Lilly Canada's first haematology launch in Canada. ...
Posted by Michael Wonder on 03 Feb 2026
Health Canada grants authorization for Bayer’s Hyrnuo (sevabertinib) for previously treated patients with locally advanced or metastatic HER2-mutant non-small cell lung cancer
2 February 2026 - Bayer is pleased to announce that Health Canada has authorized Hyrnuo (sevabertinib), oral tablets, for the treatment ...
Posted by Michael Wonder on 30 Jan 2026
Celltrion secures Canadian approval for Omlyclo 300 mg PFS and auto-injector formulations
29 January 2026 - Celltrion said Thursday that it has received additional approval from Health Canada for its chronic idiopathic ...
Posted by Michael Wonder on 29 Jan 2026
Dong-A ST receives Health Canada approval for Stelara biosimilar Imuldosa
28 January 2026 - Dong-A ST announced on Wednesday that Health Canada has granted marketing authorisation for Imuldosa (ingredient: ustekinumab), ...
Posted by Michael Wonder on 29 Jan 2026
Cipher Pharmaceuticals announces Health Canada's acceptance for review of new drug submission for Natroba (spinosad)
28 January 2026 - Cipher Pharmaceuticals today announced that Health Canada has accepted for review Cipher's new drug submission for ...
Posted by Michael Wonder on 27 Jan 2026
Health Canada authorises Gazyva (obinutuzumab) for adults with active lupus nephritis
26 January 2026 - Roche Canada is pleased to announce that on 22 January 2026, Health Canada has approved Gazyva ...
Posted by Michael Wonder on 14 Jan 2026
Bimzelz (bimekizumab injection) approved in Canada for treatment of moderate to severe hidradenitis suppurativa
13 January 2026 - The approval is based on clinically significant results from UCB's two pivotal Phase 3 trials demonstrating ...
Posted by Michael Wonder on 13 Jan 2026
Health Canada approves Rybelsus (semaglutide tablets) to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes
12 January 2026 - The indication expansion is based on positive outcomes observed in the cardiovascular outcomes (SOUL) trial data, ...
Posted by Michael Wonder on 13 Jan 2026
Galderma announces the authorisation of Nemluvio (nemolizumab) for atopic dermatitis and prurigo nodularis in Canada
12 January 2026 - Nemluvio is now authorised for sale by Health Canada based on results from the Phase III ARCADIA ...
Posted by Michael Wonder on 07 Jan 2026
Maviret receives Health Canada approval for the treatment of acute hepatitis C virus
6 January 2026 - Maviret received approval through Health Canada's priority review process, based on data from the Phase 3 M20-350 ...
Posted by Michael Wonder on 06 Jan 2026
Idorsia’s Jeraygo (aprocitentan) approved in Canada for the treatment of resistant hypertension
5 January 2026 - Idorsia announces that Health Canada has granted marketing authorisation for Jeraygo (aprocitentan) for the treatment of resistant ...
Posted by Michael Wonder on 06 Jan 2026
Arrowhead Pharmaceuticals announces Health Canada approval of Redemplo (plozasiran) to reduce triglycerides in adults with familial chylomicronaemia syndrome
5 January 2026 - The Health Canada approval is based on positive results from the Phase 3 PALISADE study where Redemplo ...
Posted by Michael Wonder on 06 Jan 2026
Moderna announces global regulatory submissions for its investigational seasonal influenza vaccine
5 January 2026 - Moderna today provided an update on regulatory submissions for its investigational seasonal influenza vaccine, mRNA-1010, for adults ...
Posted by Michael Wonder on 25 Dec 2025
Health Canada approves Tevimbra (tislelizumab for injection) in combination with gemcitabine and cisplatin for the first-line treatment of adult patients with recurrent or metastatic nasopharyngeal carcinoma
23 December 2025 - Approval supported by results of the RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival ...