Health Canada approves Saladax’s 5-fluorouracil chemotherapy therapeutic drug monitoring test

14 May 2024 - Saladax Biomedical is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale ...

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ViiV Healthcare announces Health Canada approval for Apretude (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV

13 May 2024 - The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a ...

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Health Canada approves Keytruda for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy

9 May 2024 - Approval is based on the Phase 3 KEYNOTE-966 Trial. ...

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Qulipta (atogepant) now approved by Health Canada for the preventive treatment of chronic migraine in adults

8 May 2024 - Approval was based on a pivotal Phase 3 clinical trial that demonstrated statistically significant reduction from baseline ...

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Health Canada approves Zoladex LA for the management of oestrogen receptor positive early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and peri-menopausal women

7 May 2024 - TerSera Canada today announced that Health Canada has approved a supplemental new drug submission for Zoladex LA ...

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Wegovy (semaglutide injection) available in Canada

2 May 2024 - First and only Health Canada approved once weekly medication for chronic weight management ...

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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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