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RSS FeedPosted by Michael Wonder on 09 Jan 2025
Fresenius Kabi Canada has received a Health Canada Notice of Compliance for Otulfi an ustekinumab biosimilar
8 January 2025 - Otulfi received a Health Canada Notice of Compliance approval on 30 December 2024 for both subcutaneous and ...
Posted by Michael Wonder on 21 Dec 2024
Knight Therapeutics announces filing of new drug submission for Qelbree (viloxazine) in Canada
16 December 2024 - Knight Therapeutics announced today that Knight's new drug submission for Qelbree (viloxazine extended-release capsules) has been accepted ...
Posted by Michael Wonder on 18 Dec 2024
Health Canada approves Xeomin (incobotulinumtoxinA) for treatment of adults with post-stroke lower limb spasticity in the ankle and foot
17 December 2024 - Merz Therapeutics today announced that Health Canada approved Xeomin (incobotulinumtoxinA) for the treatment of post-stroke lower limb ...
Posted by Michael Wonder on 11 Dec 2024
Health Canada approves Celltrion’s Omlyclo (CT-P39), the first and only omalizumab biosimilar in Canada
9 December 2024 - Omlyclo (CT-P39) is the first and only omalizumab biosimilar referencing Xolair approved in Canada to treat multiple ...
Posted by Michael Wonder on 07 Dec 2024
Veozah (fezolinetant film coated tablets) receives Health Canada approval as first and only non-hormonal treatment for vasomotor symptoms associated with menopause
3 December 2024 - New treatment option helps fill unmet need for women experiencing hot flashes and night sweats associated ...
Posted by Michael Wonder on 06 Dec 2024
Esperion announces new drug submissions in Canada for Nexletol (bempedoic acid) and Nexlizet (bempedoic acid and ezetimibe) treatments to reduce LDL-cholesterol and cardiovascular risk
2 December 2024 - Esperion today announced that it has filed new drug submissions to Health Canada for Nexletol and Nexlizet, ...
Posted by Michael Wonder on 05 Dec 2024
Health Canada approves Wegovy (semaglutide injection) to reduce the risk of non-fatal myocardial infarction
27 November 2024 - Wegovy is the first and only medication indicated for both chronic weight management and to reduce the ...
Posted by Michael Wonder on 15 Nov 2024
Knight Therapeutics announces Health Canada approval for Jornay PM to treat attention deficit hyperactivity disorder
14 November 2024 - Knight Therapeutics announced today that Health Canada has approved Jornay PM, an extended-release formulation of methylphenidate, a ...
Posted by Michael Wonder on 13 Nov 2024
Ojjaara (momelotinib) approved in Canada for the treatment of myelofibrosis in adults who have moderate to severe anaemia
12 November 2024 - Ojjaara (momelotinib) is the only approved treatment for newly diagnosed and previously treated myelofibrosis patients who have ...
Posted by Michael Wonder on 23 Oct 2024
Health Canada approves first and only oral targeted treatment for brain cancer
22 October 2024 - Pivotal Phase 3 study shows significant improvement in progression-free survival with a favourable safety profile. ...
Posted by Michael Wonder on 19 Oct 2024
Arcutis announces Health Canada approval of Zoryve (roflumilast) foam 0.3% to treat seborrheic dermatitis in individuals 9 years of age and older
18 October 2024 - Zoryve foam represents the first topical treatment for seborrheic dermatitis with a new mechanism of action approved ...
Posted by Michael Wonder on 18 Oct 2024
Fresenius Kabi launches Tyenne, the first and only approved tocilizumab biosimilar in Canada
17 October 2024 - Tyenne is the first and only tocilizumab biosimilar to be launched in Canada. ...
Posted by Michael Wonder on 17 Oct 2024
Incyte announces Health Canada approval of Opzelura (ruxolitinib) cream for the treatment of atopic dermatitis and non-segmental vitiligo
16 October 2024 - First and only treatment approved by Health Canada for repigmentation of non-segmental vitiligo. ...
Posted by Michael Wonder on 17 Oct 2024
Acadia Pharmaceuticals announces Health Canada approval of Daybue (trofinetide) for the treatment of Rett syndrome
16 October 2024 - Daybue is the first and only therapy approved in Canada for the treatment of Rett syndrome, a ...
Posted by Michael Wonder on 02 Oct 2024
Clinuvel files Canadian new drug submission for Scenesse in EPP
30 September 2024 - Patient special access program continues during Health Canada review. ...