Lipocine announces filing of new drug submission for Tlando in Canada

9 June 2025  - New drug submission filed by Lipocine's licensing partner Verity Pharma. ...

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GSK's depemokimab accepted for review by Health Canada for the treatment of asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps

26 May 2025 - GSK has submitted a new drug submission to Health Canada for depemokimab for two proposed indications: the ...

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Health Canada accepts semaglutide 2.4 mg, a GLP-1 receptor agonist treatment for MASH, as a supplemental new drug submission under the priority review policy

2 May 2025 - Today, Novo Nordisk Canada announced that Health Canada has accepted for review, under the priority review policy, ...

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Catalyst Pharmaceuticals announces Health Canada’s acceptance of Agamree new drug submission with priority review

8 April 2025 - Catalyst Pharmaceuticals today reported that its sub-licensee in Canada, Kye Pharmaceuticals has announced that Health Canada has ...

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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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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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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 ...

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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, ...

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Clinuvel files Canadian new drug submission for Scenesse in EPP

30 September 2024 - Patient special access program continues during Health Canada review. ...

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Vertex announces Health Canada acceptance of new drug submission for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis

26 September 2024 - Vertex Pharmaceuticals today announced that Health Canada has accepted for review its new drug submission for ...

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Valneva submits label extension applications for its chikungunya vaccine Ixchiq to EMA and Health Canada

18 September 2024 - To potentially include adolescents and antibody persistence up to two years. ...

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Biogen's new drug submission for omaveloxolone accepted for priority review by Health Canada for the treatment of Friedreich's ataxia

17 September 2024 - If approved, omaveloxolone would be the only disease specific treatment option for patients living with this progressive ...

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Marius Pharmaceuticals submits Kyzatrex (testosterone undecanoate) capsules for approval to Health Canada

30 July 2024 - Marius Pharmaceuticals is pleased to announce the submission of its new drug submission for Kyzatrex (testosterone ...

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Vertex announces FDA acceptance of new drug application for vanzacaftor/tezacaftor/deutivacaftor, a next in class triple combination treatment for cystic fibrosis

2 July 2024 - Vanza triple granted priority review with a PDUFA target action date of 2 January 2025. ...

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Novavax submits application to Health Canada for updated protein-based 2024-2025 formula COVID-19 vaccine

2 July 2024 - Novavax's filing is aligned with NACI, US. FDA, EMA and WHO recommendations on vaccine composition. ...

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