Blog
RSS FeedPosted by Michael Wonder on 23 Apr 2024
Acadia Pharmaceuticals announces trofinetide new drug submission for treatment of Rett syndrome has been accepted for filing and priority review by Health Canada
22 April 2024 - Acadia Pharmaceuticals today announced that Health Canada has accepted its new drug submission for trofinetide for the ...
Posted by Michael Wonder on 23 Apr 2024
Health Canada approves new indication for Merck’s Prevymis (letermovir) for prevention of cytomegalovirus disease in high risk adult kidney transplant recipients
19 April 2024 - Merck announced that Health Canada has approved a new indication for Prevymis (letermovir) for the prophylaxis ...
Posted by Michael Wonder on 20 Apr 2024
Nora Pharma receives Health Canada approval for Niopeg, a biosimilar of Neulasta
19 April 2024 - Nora Pharma, a wholly owned division of Sunshine Biopharma, has received approval from Health Canada for the ...
Posted by Michael Wonder on 20 Apr 2024
Health Canada approves Keytruda as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy
19 April 2024 - Approval is based on the Phase 3 KEYNOTE-859 trial. ...
Posted by Michael Wonder on 12 Apr 2024
Formycon announces commercial launch of FYB201 (ranibizumab) in Canada (Ranopto) and Switzerland (Ranivisio)
11 April 2024 - Commercialization partner Teva markets FYB201 in Canada under the trademark Ranopto and in Switzerland under the trademark ...
Posted by Michael Wonder on 10 Apr 2024
AB Science announces that Health Canada has granted eligibility for reconsideration request for masitinib in ALS
3 April 2024 - AB Science today announced that Health Canada has granted eligibility for reconsideration request for masitinib in ...
Posted by Michael Wonder on 03 Apr 2024
Vertex announces new drug submission for exagamglogene autotemcel (exa-cel) has been accepted for priority review by Health Canada for the treatment of sickle cell disease and transfusion-dependent beta thalassaemia
1 April 2024 - Exa-cel is the first CRISPR-based gene-edited therapy to be submitted for Health Canada review. ...
Posted by Michael Wonder on 29 Mar 2024
Paladin Labs announces approval of Wakix (pitolisant hydrochloride tablets) for use in paediatric patients in Canada
28 March 2024 - Indication includes children ages 6 years and older and weighing at least 30 kg. ...
Posted by Michael Wonder on 21 Mar 2024
Health Canada accepts for review new drug submission for tofersen for treatment of rare, genetic form of ALS
19 March 2024 - Health Canada regulatory decision on tofersen new drug submission expected in early 2025. ...
Posted by Michael Wonder on 21 Mar 2024
Ferinject approved by Health Canada for the treatment of iron deficiency anaemia in adult and paediatric patients and iron deficiency in adult patients with heart failure
19 March 2024 - CSL Vifor today announced that Health Canada has authorised Ferinject (ferric carboxymaltose) for the intravenous treatment of ...
Posted by Michael Wonder on 15 Mar 2024
Bimzelx (bimekizumab) now approved for adults with active psoriatic arthritis and for adults with axial spondyloarthritis
14 March 2024 - Health Canada's approval is supported by Phase III clinical trial data which found Bimzelx provided significant improvement ...
Posted by Michael Wonder on 13 Mar 2024
Sumitomo Pharma announces availability of Orgovyx (relugolix) in Canada, the first and only oral androgen deprivation therapy treatment for men with advanced prostate cancer
12 March 2024 - Sumitomo Pharma announced today that Orgovyx (relugolix), an oral gonadotropin-releasing hormone receptor antagonist, is now available for ...
Posted by Michael Wonder on 06 Mar 2024
Wezlana (ustekinumab), a biosimilar to Stelara, now available in Canada for certain chronic inflammatory diseasee
4 March 2024 - Wezlana is the first biosimilar to Stelera to be available for Canadian patients in all indications. ...
Posted by Michael Wonder on 05 Mar 2024
AB Science today announces that Health Canada has issued a screening acceptance letter for the application of masitinib in the treatment of amyotrophic lateral sclerosis
9 May 2023 - AB Science today announces that Health Canada has issued a screening acceptance letter for ...
Posted by Michael Wonder on 28 Feb 2024
AB Science announces that Health Canada has issued a notice of non-compliance-withdrawal for masitinib in ALS
26 February 2024 - AB Science today announces that Health Canada has issued a notice of non-compliance-withdrawal regarding its new ...