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RSS FeedPosted 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 02 Jun 2022
Health Canada OKs Pfizer COVID-19 booster shot for teens ages 16 and 17
1 June 2022 - Canada on Wednesday authorised a single booster shot of Pfizer and partner BioNTech’s COVID-19 vaccine for ...
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 20 May 2022
Viatris and Biocon Biologics launch Abevmy (bevacizumab), their third oncology siosimilar, in Canada
19 May 2022 - Viatris and Biocon Biologics announced today that Abevmy (bevacizumab) is now available in Canada. ...
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 14 May 2022
Health Canada accepts SNDS filing and grants priority review of oral edarvarone formulation for the treatment of ALS
13 May 2022 - Mitsubishi Tanabe Pharma Canada announced today that Health Canada has accepted the filing of a supplement to ...
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 01 May 2022
Moderna submits COVID-19 vaccine for kids 5 and under to Health Canada for review
29 April 2022 - Moderna has asked Health Canada to approve its COVID-19 vaccine for children as young as six ...
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
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 6 through 11 years with at least one F508del mutation
20 April 2022 - Vertex has submitted this indication to CADTH & INESSS for health technology assessments. ...
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 ...