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RSS FeedPosted by Michael Wonder on 11 Jul 2022
Arcutis Biotherapeutics announces Health Canada accepts for review the new drug submission for roflumilast cream for adults and adolescents with plaque psoriasis
11 July 2022 - Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as ...
Posted by Michael Wonder on 06 Jul 2022
Regulatory submission for GSK's daprodustat accepted into Health Canada review
6 July 2022 - Canadian regulatory submission acceptance follows that of the US FDA and the EMA as well as ...
Posted by Michael Wonder on 14 May 2022
Health Canada accepts SNDS filing and grants priority review of oral edarvarone formulation for the treatment of ALS
13 May 2022 - Mitsubishi Tanabe Pharma Canada announced today that Health Canada has accepted the filing of a supplement to ...
Posted by Michael Wonder on 22 Mar 2022
KYE Pharmaceuticals files Accrufer new drug submission in Canada for the treatment of iron deficiency
21 March 2022 - Shield Therapeutics announces that KYE Pharmaceuticals has submitted a new drug submission to Health Canada for ...
Posted by Michael Wonder on 10 Dec 2021
VBI Vaccines announces filing of new drug submission for 3 antigen hepatitis B vaccine to Health Canada
9 December 2021 - VBI Vaccines today announced the filing of a new drug submission to Health Canada for the Company’s ...
Posted by Michael Wonder on 02 Dec 2021
Pfizer Canada initiates submission to Health Canada for COVID-19 oral anti-viral candidate
1 December 2021 - Pfizer Canada today initiated the filing of a rolling new drug submission with Health Canada for its ...
Posted by Michael Wonder on 05 Nov 2021
AstraZeneca Canada files for Health Canada authorisation of AZD7442 for prevention of COVID-19
3 November 2021 - AstraZeneca Canada has initiated a rolling review new drug submission with Health Canada for authorization of ...
Posted by Michael Wonder on 27 Oct 2021
Vertex's supplement to a new drug aubmission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in patients ages 6-11 accepted for priority review by Health Canada
27 October 2021 - Vertex Pharmaceuticals today announced that its supplement to a new drug submission for Trikafta (elexacaftor/tezacaftor/ivacaftor and ...
Posted by Michael Wonder on 19 Oct 2021
Health Canada receives submission from Pfizer-BioNTech to authorise the use of Comirnaty COVID-19 vaccine in children 5 to 11 years of age
18 October 2021 - Today, Health Canada received a submission from Pfizer-BioNTech seeking an authorisation for the use of its Comirnaty ...
Posted by Michael Wonder on 07 Oct 2021
Moderna asks Health Canada to approve COVID-19 vaccine booster shot
5 October 2021 - Moderna has applied for Canadian approval of a third dose of its COVID-19 vaccine, the company ...
Posted by Michael Wonder on 25 Sep 2021
Vertex's supplement to a new drug submission for Kalydeco (ivacaftor) for patients with cystic fibrosis between the ages of 4 months and 18 years with the R117H mutation in the CFTR gene accepted for priority review by Health Canada
22 September 2021 - Vertex Pharmaceuticals today announced its supplement to a new drug submission for Kalydeco (ivacaftor) has been ...
Posted by Michael Wonder on 01 Sep 2021
Amylyx Pharmaceuticals announces Health Canada accepts for review the new drug submission for AMX0035 for the treatment of ALS
31 August 2021 - Amylyx Pharmaceuticals today announced that Health Canada has accepted for review the new drug submission for AMX0035 ...
Posted by Michael Wonder on 27 Aug 2021
BioCryst announces acceptance of regulatory applications for Orladeyo (berotralstat) by Health Canada and Swissmedic
25 August 2021 - BioCryst Pharmaceuticals today announced that the new drug submission for Orladeyo (berotralstat) has been accepted for ...
Posted by Michael Wonder on 16 Aug 2021
Merck Canada initiates rolling submission to Health Canada for molnupiravir, an investigational oral therapeutic agent for the treatment of COVID-19
13 August 2021 - Merck today announced the initiation of a rolling submission to Health Canada for molnupiravir, an investigational twice ...
Posted by Michael Wonder on 03 Aug 2021
Celltrion Healthcare announces acceptance and priority review by Health Canada of New Drug Submission for its monoclonal antibody treatment for COVID-19, regdanvimab (CT-P59)
2 August 2021 - Celltrion Healthcare Canada remains committed to working closely with Health Canada to make its monoclonal antibody treatment ...