Health Canada authorises Rybrevant (amivantamab) in combination with carboplatin and pemetrexed as the only targeted first-line treatment approved for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations

3 July 2024 - Phase 3 PAPILLON study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival, ...

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Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older

25 June 2024 - Patients treated with Ebglyss experienced significant skin clearance and itch relief as early as 4 weeks. ...

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Valneva announces Health Canada approval of the world’s first chikungunya vaccine, Ixchiq

24 June 2024 - Valneva today announced that Health Canada has approved Ixchiq, Valneva’s single-dose vaccine for the prevention of ...

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Takeda's HyQvia approved as replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in paediatric patients 2 years of age and older

21 June 2024 - Takeda Canada is pleased to announce that Health Canada has expanded the marketing authorisation for HyQvia (normal ...

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Health Canada approves Cosentyx, a biologic therapy, for the treatment of adults with moderate to severe hidradenitis suppurativa

22 May 2024 - Approval is based on the two largest Phase 3 trials conducted in hidradenitis suppurativa – SUNSHINE and SUNRISE ...

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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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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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