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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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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Health Canada authorizes Itovebi (inavolisib film-coated tablets), a targeted treatment for advanced hormone receptor-positive, HER2 negative breast cancer with a PIK3CA mutation

19 February 2025 - The approval provides another treatment option for breast cancer patients with a PIK3CA mutation, one of the ...

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Eylea HD pre-filled syringe with OcuClick dosing system granted marketing authorisation in Canada

20 February 2025 - Bayer is pleased to announce that Health Canada has granted marketing authorisation for Eylea HD (aflibercept injection ...

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Novartis receives Health Canada approval for Fabhalta oral treatment for adult patients with paroxysmal nocturnal haemoglobinuria

13 February 2025 - Fabhalta is the first oral monotherapy for previously treated and treatment naïve adults with paroxysmal nocturnal haemoglobinuria. ...

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Health Canada approves Merck's Keytruda (pembrolizumab) for the treatment of adult patients with resectable Stage II, IIIA, or IIIB (T3-4N2) non-small cell lung carcinoma (NSCLC) in combination with platinum-containing chemotherapy as neo-adjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery

11 February 2025 - Approval is based on the Phase 3 KEYNOTE-671 trial. ...

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Takeda's Fruzaqla (fruquintinib) receives Health Canada market authorisation for metastatic colorectal cancer

20 January 2025 - Positive reimbursement recommendations by Canada's Drug Agency and Institut National d'excellence en Santé et Services Sociaux. ...

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Health Canada authorises Vabysmo (faricimab injection) pre-filled syringe for three leading causes of vision loss

20 January 2025 - Vabysmo pre-filled syringe is the first and only syringe pre-filled with a Health-Canada approved bispecific antibody to ...

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