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RSS FeedPosted by Michael Wonder on 24 Jun 2022
Health Canada expands approval of Enhertu for adults with HER2 positive metastatic breast cancer
23 June 2022 - Approval based on the ground-breaking DESTINY-Breast03 Phase 3 trial, showing Enhertu reduced the risk of disease ...
Posted by Michael Wonder on 19 Jun 2022
Canadian regulator OKs Hugel's botulinum toxin product
16 June 2022 - Hugel said Thursday that it has obtained product approval from Health Canada for its botulinum toxin ...
Posted by Michael Wonder on 13 Jun 2022
Amylyx Pharmaceuticals announces Health Canada approval of Albrioza for the treatment of ALS
13 June 2022 - Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ...
Posted by Michael Wonder on 08 Jun 2022
Health Canada approves Tabrecta: targeted cancer therapy for locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations
8 June 2022 - Newest treatment for lung cancer reinforces Novartis commitment to developing innovative therapies that improve outcomes for ...
Posted by Michael Wonder on 08 Jun 2022
The UK MHRA, Australian TGA and Health Canada approve Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
8 June 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall survival ...
Posted by Michael Wonder on 08 Jun 2022
Forus Therapeutics announces Xpovio (selinexor) is authorised for sale by Health Canada
7 June 2022 - FORUS Therapeutics is pleased to announce that on 31 May 2022, Xpovio (selinexor) was authorised for ...
Posted by Michael Wonder on 06 Jun 2022
BioCryst announces Health Canada has authorised Orladeyo (berotralstat), the only oral treatment for the prevention of hereditary angioedema attacks
6 June 2022 - BioCryst Pharmaceuticals today announced that Health Canada has approved oral, once daily Orladeyo (berotralstat) for the ...
Posted by Michael Wonder on 01 Jun 2022
Health Canada authorises Vabysmo (faricimab injection) for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular oedema
1 June 2022 - Vabysmo (faricimab injection) is the first bispecific antibody that acts by neutralising both VEGF-A and Ang-2 ...
Posted by Michael Wonder on 25 May 2022
Bausch + Lomb receives Health Canada approval of Lumify redness reliever eye drops
24 May 2022 - Lumify is Canada's first and only over the counter eye drop with low dose brimonidine for ...
Posted by Michael Wonder on 18 May 2022
Alnylam announces Health Canada authorisation of Oxlumo (lumasiran), the first and only treatment for primary hyperoxaluria type 1 to lower urinary oxalate levels in paediatric and adult patients
18 May 2022 - Authorization based on two pivotal Phase 3 trials, ILLUMINATE-A and ILLUMINATE-B; showing significant reduction in urinary ...
Posted by Michael Wonder on 05 May 2022
Health Canada approves Ipsen's Cabometyx (cabozantinib) for patients with previously treated radioactive iodine refractory or ineligible differentiated thyroid cancer
Pivotal Phase 3 trial data showed Cabometyx demonstrated a significant improvement in progression-free survival. ...
Posted by Michael Wonder on 27 Apr 2022
Health Canada approves Vraylar (cariprazine) for the treatment of bipolar l disorder and schizophrenia in adults
27 April 2022 - Vraylar is a new atypical antipsychotic medication with partial agonist activity at central dopamine D3 receptors ...
Posted by Michael Wonder on 20 Apr 2022
Otsuka announces Health Canada approval of Tavneos (avacopan) for ANCA associated vasculitis
20 April 2022 - Launch is expected in Canada in the fourth quarter of 2022. ...
Posted by Michael Wonder on 19 Apr 2022
Health Canada approves Keytruda (pembrolizumab) for the treatment of adult patients with high risk early stage triple negative breast cancer in combination with chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery
18 April 2022 - Approval Based on Data from Phase 3 KEYNOTE-522 Trial ...
Posted by Michael Wonder on 15 Apr 2022
Evusheld receives Health Canada approval for pre-exposure prophylaxis (prevention) of COVID-19 in immune-compromised individuals
14 April 2022 - Evusheld is the first long-acting antibody combination to receive Health Canada authorisation for the prevention of ...