Scilex announces approval of a new drug submission from the Health Canada for Elyxyb’s acute treatment of migraine with or without aura in Canada

15 April 2025 - Elyxyb is a first-line treatment and the only FDA approved, ready to use oral solution for the ...

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Health Canada approves Nduvra (tapinarof 1% cream) for the topical treatment of plaque psoriasis in adults

14 April 2025 - Organon today announced that Health Canada has approved Nduvra (tapinarof cream), 1%, the first in a novel ...

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Health Canada approves Imfinzi (durvalumab) as the first and only immunotherapy regimen for adult patients with limited-stage small cell lung cancer

10 April 2025 - Health Canada has granted a Notice of Compliance for Imfinzi (durvalumab), as monotherapy, for the treatment ...

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Catalyst Pharmaceuticals announces Health Canada’s acceptance of Agamree new drug submission with priority review

8 April 2025 - Catalyst Pharmaceuticals today reported that its sub-licensee in Canada, Kye Pharmaceuticals has announced that Health Canada has ...

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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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Takeda’s HyQvia receives expanded market authorisation as maintenance therapy for chronic inflammatory demyelinating polyneuropathy

27 March 2025 - HyQvia is the only up to once monthly (every 2, 3 or 4 weeks) immunoglobulin subcutaneous ...

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Hikma announces Health Canada approval of Kloxxado (naloxone hydrochloride) nasal spray 8 mg

20 March 2025 - Emergent BioSolutions will lead commercial launch efforts to increase access to intranasal naloxone and combat opioid overdose ...

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Health Canada approves Keytruda for the treatment of adult patients with primary advanced or recurrent endometrial carcinoma, in combination with carboplatin and paclitaxel and then continued as monotherapy

19 March 2025 - Approval is based on the Phase 3 KEYNOTE-868/NRG-GY018 trial. ...

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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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Pfizer's Ixifi will be available in Canada as of 1 April 2025

17 March 2025 - Ixifi is available in more than 20 countries and was approved by Health Canada in December 2021. ...

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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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Celltrion's infliximab, the first monoclonal antibody biosimilar, is now Remdantry in Canada

11 March 2025 - CT-P13, intravenous infliximab, developed and manufactured by Celltrion, is the first monoclonal antibody biosimilar therapy and has ...

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ACCRUFeR (ferric maltol) is now available in Canada as a prescription oral treatment for iron deficiency anaemia

11 March 2025 - ACCRUFeR is the only oral iron therapy approved as a prescription drug in Canada. ...

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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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