Velsipity receives Health Canada approval for adults with moderately to severely active ulcerative colitis

24 April 2024 - Velsipity is a once daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P ...

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Health Canada authorizes Tecentriq SC (atezolizumab solution for subcutaneous injection), the first cancer immunotherapy subcutaneous injection, for multiple cancer types

23 April 2024 - Roche Canada will be working closely with the pan-Canadian Pharmaceutical Alliance, as well as federal, provincial, ...

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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 ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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. ...

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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. ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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