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RSS FeedPosted by Michael Wonder on 13 Feb 2023
Mitsubishi Tanabe Pharma Canada announces Radicava (edaravone) oral suspension is now available in Canada for the treatment of patients with ALS
10 February 2023 - Mitsubishi Tanabe Pharma Canada today announced that Radicava oral suspension, the oral formulation of Radicava IV ...
Posted by Michael Wonder on 11 Feb 2023
Health Canada approves Adtralza (tralokinumab) for the treatment of adolescents aged 12 to 17 with moderate to severe atopic dermatitis
8 February 2023 - Adtralza is the first treatment for adolescents with moderate to severe atopic dermatitis specifically targeting the ...
Posted by Michael Wonder on 27 Jan 2023
Valeo Pharma announces filing of a new drug submission with Health Canada for sabizabulin for the treatment of hospitalised COVID-19 patients
26 January 2023 - In the final analysis of the Phase 3 clinical study conducted by Veru, sabizabulin showed a 51.6% ...
Posted by Michael Wonder on 19 Jan 2023
Health Canada accepts nirsevimab regulatory submission for infant RSV
18 January 2023 - Nirsevimab is the first investigational long-acting antibody designed for all infants to help protect against respiratory syncytial ...
Posted by Michael Wonder on 18 Jan 2023
Medunik Canada obtains new Notice of Compliance from Health Canada for Ruzurgi (amifampridine) following a favourable Canadian Federal Court of Appeal ruling
17 January 2023 - Medunik Canada is pleased to announce that on 9 January 2023, the Federal Court of Appeal of ...
Posted by Michael Wonder on 18 Jan 2023
Ultomiris approved in Canada for adults with generalied myasthenia gravis
17 January 2023 - First and only long acting C5 complement inhibitor to demonstrate clinical improvement in patients with generalised ...
Posted by Michael Wonder on 17 Jan 2023
Celltrion gets nod from Canadian regulator for sales of Avastin biosimilar
17 January 2023 - Celltrion obtained permission from Health Canada to sell Avastin (bevacizumab) biosimilar Vegzelma (CT-P16) on Tuesday. ...
Posted by Michael Wonder on 13 Jan 2023
Enhertu approved by Health Canada as the first HER2 directed therapy for patients with HER2 low metastatic breast cancer
12 January 2023 - Approval based on the DESTINY-Breast04 results which showed Enhertu reduced risk of disease progression or death ...
Posted by Michael Wonder on 10 Jan 2023
Qulipta now approved by Health Canada for the preventive treatment of episodic migraine in adults
9 January 2023 - Qulipta is the first and only oral calcitonin gene-related peptide receptor antagonist (gepant) specifically developed for the ...
Posted by Michael Wonder on 08 Jan 2023
JAMP Pharma Group receives Health Canada approval for JAMP Sitagliptin, a new generic alternative for the treatment of type 2 diabetes
6 January 2022 - The JAMP Pharma Group is pleased to announce the Health Canada approval of JAMP Sitagliptin, a generic ...
Posted by Michael Wonder on 04 Jan 2023
Samsung Bioepis announces Health Canada approval of citrate free high concentration of Humira biosimilar (adalimumab; SB5)
3 January 2023 - With the approval, Samsung Bioepis has both low (40 mg/0.8 mL) and high (40 mg/0.4 mL) concentration ...
Posted by Michael Wonder on 21 Dec 2022
Aequus announces Health Canada Notice of Compliance for Zimed Preservative Free (bimatoprost 0.03%)
20 December 2022 - Aequus Pharmaceuticals is pleased to announce that Health Canada has approved Zimed PF (bimatoprost 0.03%) for ...
Posted by Michael Wonder on 19 Dec 2022
Draft guidance document on the collection and analysis of disaggregated data in clinical trials: transparency
16 December 2022 - This guidance will help sponsors interpret amendments to the Food and Drug Regulations (regulations) requiring them ...
Posted by Michael Wonder on 10 Dec 2022
Health Canada authorises the Pfizer-BioNTech Omicron BA.4/BA.5 bivalent adapted COVID-19 booster for children 5 to 11 years of age
9 December 2022 - Today, Health Canada authorised the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent adapted booster for use in children 5 ...
Posted by Michael Wonder on 10 Dec 2022
VBI Vaccines announces Health Canada approval for PreHevbrio for the prevention of hepatitis B in adults
8 December 2022 - VBI Vaccines today announced that Health Canada has approved PreHevbrio [3 antigen hepatitis B vaccine (recombinant)] for ...