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RSS FeedPosted by Michael Wonder on 16 Jul 2024
Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) for people with cystic fibrosis aged 2 years and older with certain rare mutations
15 July 2024 - Approximately 200 people with certain rare CF mutations are now eligible for Trikafta. ...
Posted by Michael Wonder on 13 Jul 2024
Health Canada approves Tagrisso with the addition of chemotherapy for patients with EGFR mutated advanced lung cancer
12 July 2024 - Approval based on FLAURA2 results, which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly ...
Posted by Michael Wonder on 04 Jul 2024
Health Canada authorises Rybrevant (amivantamab) in combination with carboplatin and pemetrexed as the only targeted first-line treatment approved for patients with non-small cell lung cancer with EGFR exon 20 insertion mutations
3 July 2024 - Phase 3 PAPILLON study showed Rybrevant in combination with carboplatin and pemetrexed significantly improved progression-free survival, ...
Posted by Michael Wonder on 26 Jun 2024
Health Canada authorizes Lilly's Ebglyss (lebrikizumab) for the treatment of moderate to severe atopic dermatitis in adults and adolescents 12 years and older
25 June 2024 - Patients treated with Ebglyss experienced significant skin clearance and itch relief as early as 4 weeks. ...
Posted by Michael Wonder on 25 Jun 2024
Valneva announces Health Canada approval of the world’s first chikungunya vaccine, Ixchiq
24 June 2024 - Valneva today announced that Health Canada has approved Ixchiq, Valneva’s single-dose vaccine for the prevention of ...
Posted by Michael Wonder on 22 Jun 2024
Takeda's HyQvia approved as replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in paediatric patients 2 years of age and older
21 June 2024 - Takeda Canada is pleased to announce that Health Canada has expanded the marketing authorisation for HyQvia (normal ...
Posted by Michael Wonder on 23 May 2024
Health Canada approves Cosentyx, a biologic therapy, for the treatment of adults with moderate to severe hidradenitis suppurativa
22 May 2024 - Approval is based on the two largest Phase 3 trials conducted in hidradenitis suppurativa – SUNSHINE and SUNRISE ...
Posted by Michael Wonder on 17 May 2024
Health Canada approves Saladax’s 5-fluorouracil chemotherapy therapeutic drug monitoring test
14 May 2024 - Saladax Biomedical is pleased to announce that Health Canada has approved Saladax’s 5-Fluorouracil (My5-FU) Assay for sale ...
Posted by Michael Wonder on 15 May 2024
ViiV Healthcare announces Health Canada approval for Apretude (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV
13 May 2024 - The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a ...
Posted by Michael Wonder on 11 May 2024
Health Canada approves Keytruda for adult patients with locally advanced unresectable or metastatic biliary tract carcinoma, in combination with gemcitabine-based chemotherapy
9 May 2024 - Approval is based on the Phase 3 KEYNOTE-966 Trial. ...
Posted by Michael Wonder on 10 May 2024
Qulipta (atogepant) now approved by Health Canada for the preventive treatment of chronic migraine in adults
8 May 2024 - Approval was based on a pivotal Phase 3 clinical trial that demonstrated statistically significant reduction from baseline ...
Posted by Michael Wonder on 09 May 2024
Health Canada approves Zoladex LA for the management of oestrogen receptor positive early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and peri-menopausal women
7 May 2024 - TerSera Canada today announced that Health Canada has approved a supplemental new drug submission for Zoladex LA ...
Posted by Michael Wonder on 04 May 2024
Wegovy (semaglutide injection) available in Canada
2 May 2024 - First and only Health Canada approved once weekly medication for chronic weight management ...
Posted by Michael Wonder on 25 Apr 2024
Velsipity receives Health Canada approval for adults with moderately to severely active ulcerative colitis
24 April 2024 - Velsipity is a once daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P ...
Posted by Michael Wonder on 24 Apr 2024
Health Canada authorizes Tecentriq SC (atezolizumab solution for subcutaneous injection), the first cancer immunotherapy subcutaneous injection, for multiple cancer types
23 April 2024 - Roche Canada will be working closely with the pan-Canadian Pharmaceutical Alliance, as well as federal, provincial, ...