Paladin Labs announces approval of Wakix (pitolisant hydrochloride tablets) for use in paediatric patients in Canada

28 March 2024 - Indication includes children ages 6 years and older and weighing at least 30 kg. ...

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Health Canada accepts for review new drug submission for tofersen for treatment of rare, genetic form of ALS

19 March 2024 - Health Canada regulatory decision on tofersen new drug submission expected in early 2025. ...

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Ferinject approved by Health Canada for the treatment of iron deficiency anaemia in adult and paediatric patients and iron deficiency in adult patients with heart failure

19 March 2024 - CSL Vifor today announced that Health Canada has authorised Ferinject (ferric carboxymaltose) for the intravenous treatment of ...

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Bimzelx (bimekizumab) now approved for adults with active psoriatic arthritis and for adults with axial spondyloarthritis

14 March 2024 - Health Canada's approval is supported by Phase III clinical trial data which found Bimzelx provided significant improvement ...

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Sumitomo Pharma announces availability of Orgovyx (relugolix) in Canada, the first and only oral androgen deprivation therapy treatment for men with advanced prostate cancer

12 March 2024 - Sumitomo Pharma announced today that Orgovyx (relugolix), an oral gonadotropin-releasing hormone receptor antagonist, is now available for ...

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Wezlana (ustekinumab), a biosimilar to Stelara, now available in Canada for certain chronic inflammatory diseasee

4 March 2024 - Wezlana is the first biosimilar to Stelera to be available for Canadian patients in all indications. ...

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AB Science today announces that Health Canada has issued a screening acceptance letter for the application of masitinib in the treatment of amyotrophic lateral sclerosis

9 May 2023 - AB Science today announces that Health Canada has issued a screening acceptance letter for ...

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AB Science announces that Health Canada has issued a notice of non-compliance-withdrawal for masitinib in ALS

26 February 2024 - AB Science today announces that Health Canada has issued a notice of non-compliance-withdrawal regarding its new ...

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GSK's RSV vaccine, Arexvy, accepted for review by Health Canada for prevention of RSV disease in adults aged 50-59 at increased risk

26 February 2024 - Submission supported by positive results of a Phase 3 study showing immune response and tolerability in adults ...

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Sandoz receives Health Canada approval for Jubbonti, first and only denosumab biosimilar for treatment of osteoporosis

20 February 2024 - Biosimilar Jubbonti approved for all indications of Prolia reference medicine. ...

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Health Canada approves Remsima SC for the treatment of inflammatory bowel disease

18 February 2024 - The approval is based on results from the LIBERTY studies demonstrating superior efficacy and comparable safety profiles ...

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Elrexfio is authorised by Health Canada for adults with relapsed or refractory multiple myeloma in Canada

13 February 2024 - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions to Elrexfio ...

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Health Canada approves Keytruda in combination with trastuzumab and chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1

12 February 2024 - Approval is based on the Phase 3 KEYNOTE-811 Trial. ...

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AbbVie's Vyalev (foslevodopa/foscarbidopa solution) available for the treatment of advanced Parkinson's disease in Canada

8 February 2024 - In clinical trials, patients taking Vyalev achieved the primary endpoint of a reduction in motor fluctuations ...

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Health Canada approves Brukinsa (zanubrutinib) for the treatment of relapsed or refractory follicular lymphoma

7 February 2024 - Brukinsa is the first and only BTK inhibitor approved for follicular lymphoma in Canada. ...

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