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RSS FeedPosted 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 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
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 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 ...
Posted by Michael Wonder on 20 Feb 2024
Sandoz receives Health Canada approval for Jubbonti, first and only denosumab biosimilar for treatment of osteoporosis
20 February 2024 - Biosimilar Jubbonti approved for all indications of Prolia reference medicine. ...
Posted by Michael Wonder on 19 Feb 2024
Health Canada approves Remsima SC for the treatment of inflammatory bowel disease
18 February 2024 - The approval is based on results from the LIBERTY studies demonstrating superior efficacy and comparable safety profiles ...
Posted by Michael Wonder on 15 Feb 2024
Elrexfio is authorised by Health Canada for adults with relapsed or refractory multiple myeloma in Canada
13 February 2024 - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions to Elrexfio ...
Posted by Michael Wonder on 14 Feb 2024
Health Canada approves Keytruda in combination with trastuzumab and chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1
12 February 2024 - Approval is based on the Phase 3 KEYNOTE-811 Trial. ...
Posted by Michael Wonder on 08 Feb 2024
Health Canada approves Brukinsa (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma
7 February 2024 - Brukinsa is the first and only BTK inhibitor approved for follicular lymphoma in Canada. ...
Posted by Michael Wonder on 06 Feb 2024
Chiesi Global Rare Diseases announces Health Canada approval of Myalepta (metreleptin for injection) for the treatment of patients with lipodystrophy
5 February 2024 - Canadian patients living with this ultra-rare condition welcome this new treatment option. ...
Posted by Michael Wonder on 31 Jan 2024
Lilly's Olumiant (baricitinib) now authorised in Canada for adults with severe alopecia areata
30 January 2024 - 17-22% of patients taking Olumiant 2 mg/day and 32-35% of patients taking Olumiant 4 mg/day achieved 80% ...
Posted by Michael Wonder on 31 Jan 2024
Xtandi (enzalutamide) receives Health Canada approval as the first and only treatment for high risk patients with non-metastatic castration sensitive prostate cancer
30 January 2024 - Today, Astellas Pharma Canada announced that Health Canada has approved a supplemental new drug application for ...