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RSS FeedPosted 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 ...
Posted by Michael Wonder on 16 Jul 2021
Ocugen announces initiation of rolling submission to Health Canada for Covaxin
15 July 2021 - Ocugen today announced that it had initiated a rolling submission to Health Canada for Covaxin, the ...
Posted by Michael Wonder on 15 Jun 2021
Amylyx Pharmaceuticals files new drug submission for AMX0035 for the treatment of ALS in Canada
14 June 2021 - Submission supported by data from the CENTAUR trial. ...
Posted by Michael Wonder on 11 Jun 2021
Controversial Alzheimer’s drug approved in U.S. Where does Canada stand?
10 June 2021 - The Alzheimer Society of Canada welcomed the new treatment urging Canadian health authorities to complete its required ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for authorisation with Health Canada for its COVID-19 vaccine in adolescents
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 03 Jun 2021
Health Canada accepts new drug submission for Reduvo as a treatment for patients with chemotherapy-induced nausea and vomiting
2 June 2021 - Tetra Bio-Pharma announced today that Health Canada has accepted its new drug submission for Reduvo and has ...
Posted by Michael Wonder on 27 Apr 2021
Health Canada initiates the review of the rolling submission for the first Canadian based COVID-19 vaccine candidate
23 April 2021 - Medicago is pleased to announce that Health Canada received for review the first portion of Medicago’s ...
Posted by Michael Wonder on 23 Feb 2021
AstraZeneca vaccine review is in the 'final stages,' Health Canada says
22 February 2021 - Health Canada has received all the necessary scientific data but questions for the company remain. ...
Posted by Michael Wonder on 07 Feb 2021
Novavax announces start of rolling review by multiple regulatory authorities for COVID-19 vaccine authorisation
4 February 2021 - Rolling reviews have commenced by FDA, MHRA, EMA and Health Canada. ...
Posted by Michael Wonder on 01 Feb 2021
Novavax submits vaccine for approval as Ottawa seeks EU reassurances on export rules
31 January 2021 - Canada's hopes of speeding up COVID-19 vaccinations brightened slightly over the weekend as regulators began work ...
Posted by Michael Wonder on 13 Jan 2021
MorphoSys and Incyte announce acceptance by Health Canada of the new drug submission for tafasitamab
12 January 2021 - MorphoSys and Incyte today announced that Health Canada has accepted the new drug submission for tafasitamab, an ...
Posted by Michael Wonder on 31 Dec 2020
Tetra Bio-Pharma files new drug submission for Reduvo in Canada
30 December 2020 - The addressable market is estimated to be $80 million CDN by 2022. ...
Posted by Michael Wonder on 29 Dec 2020
Vertex announces new drug submission for investigational triple combination medicine for the treatment of cystic fibrosis has been accepted for priority review by Health Canada
28 December 2020 - Vertex Pharmaceuticals Incorporated today announced its New Drug Submission for Trikafta, Vertex’s investigational triple combination medicine, ...