Itulatek approved for treatment of children and adolescents in Canada

8 May 2025 - ALK today announced that Health Canada has approved ALK’s regulatory filing for Itulatek (tree pollen sublingual allergy ...

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Health Canada approves Iqirvo as a first-in-class dual-peroxisome proliferator-activated receptor treatment for primary biliary cholangitis

28 April 2025 - Iqirvo (elafibranor) is the first new medicine approved in nearly a decade for the treatment of ...

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Sarclisa approved in Canada for patients with newly diagnosed multiple myeloma

22 April 2025 - This is the third indication for Sarclisa in Canada for the treatment of multiple myeloma. ...

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Rystiggo now approved for adults with generalised myasthenia gravis in Canada

2 April 2025 - The approval is supported by the pivotal Phase 3 MycarinG study in gMG, which demonstrated that treatment ...

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Zorvye cream 0.15% approved by Health Canada for the treatment of mild to moderate atopic dermatitis in adults and children as young as six years of age

17 March 2025 - Once daily, steroid free topical treatment designed to rapidly reduce itch and proactively support long term disease ...

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Skyclarys (omaveloxolone) approval by Health Canada ushers in a new era for Friedreich's ataxia treatment in Canada

17 March 2025 - As the only approved treatment to address disease progression, Skyclarys addresses a long standing gap in the ...

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Health Canada authorises Lazcluze (lazertinib) in combination with Rybrevant (amivantamab) as a first-line chemotherapy-free treatment for patients with EGFR-mutated advanced lung cancer

10 March 2025 - Phase 3 MARIPOSA study showed Lazcluze plus Rybrevant significantly improved progression-free survival, reducing the risk of ...

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Acarizax approved in Canada for treatment of young children

7 March 2025 - ALK today announced that Health Canada has approved ALK’s Acarizax tablet for use in children, aged ...

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Ferring receives Health Canada approval for Rebyota (faecal microbiota, live)

6 March 2025 - A novel first in class microbiome restoration therapy for the prevention of recurrence of C. difficile infection. ...

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Qalsody (tofersen injection) receives conditional marketing authorisation from Health Canada as the first ALS treatment targeting a genetic cause

3 March 2025 - Biogen's second rare disease therapy to be approved in Canada reflects a continued commitment to advancing ...

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Kashiv BioSciences obtains marketing authorisation for pegfilgrastim injection from Health Canada

25 February 2025 - Kashiv BioSciences today announced that Health Canada has granted marketing authorisation for its pegfilgrastim injection, enabling its ...

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