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RSS FeedPosted 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, ...
Posted by Michael Wonder on 27 Dec 2020
Dr. Reddy's Laboratories, Global Response Aid, and Appili Therapeutics announce the filing of an application for Reeqonus (favipiravir) tablets for the treatment of COVID-19 under Health Canada’s Interim Order
22 December 2020 - Dr. Reddy’s Laboratories, Appili Therapeutics and Global Response Aid today announced that Dr. Reddy’s Canada has ...
Posted by Michael Wonder on 03 Dec 2020
Janssen seeks Health Canada approval for its COVID-19 vaccine
1 December 2020 - Regulator currently evaluating data from 4 vaccine makers. ...
Posted by Michael Wonder on 18 Nov 2020
Knight Therapeutics announces filing of supplement to a new drug submission for Nerlynx (neratinib) to treat HER2-positive metastatic breast cancer
3 September 2020 - Knight Therapeutics Inc. announced filing of the supplement to a new drug submission (SNDS) of Nerlynx ...
Posted by Michael Wonder on 27 Oct 2020
Incyte announces Health Canada acceptance of the new drug submission for pemigatinib as a treatment for patients with cholangiocarcinoma
26 October 2020 - Incyte today announced that Health Canada has accepted its new drug submission for pemigatinib, a selective fibroblast ...
Posted by Michael Wonder on 13 Oct 2020
Moderna announces initiation of rolling submission to Health Canada for mRNA vaccine against COVID-19 (mRNA-1273)
13 October 2020 - Confirmation underscores Moderna’s commitment to make its vaccine available in Canada. ...
Posted by Michael Wonder on 10 Oct 2020
Pfizer Canada and BioNTech initiate rolling submission to Health Canada for SARS-CoV-2 vaccine candidate BNT162b2
9 October 2020 - Pfizer Canada and BioNTech will continue regular and open dialogue with Health Canada providing results from their ...
Posted by Michael Wonder on 10 Sep 2020
BeiGene announces acceptance and priority review by Health Canada of new drug submission for Brukinsa (zanubrutinib) in Waldenström’s macroglobulinaemia
9 September 2020 - BeiGene today announced that its new drug submission for Brukinsa (zanubrutinib) for the treatment of patients with ...
Posted by Michael Wonder on 27 May 2020
Rockwell Medical files new drug submission with Health Canada for marketing approval of Triferic AVNU
26 May 2020 - Rockwell Medical today announced the filing of a new drug submission with Health Canada for Triferic AVNU ...
Posted by Michael Wonder on 21 May 2020
Mithra and Searchlight Pharma announce filing of new drug submission for Estelle in Canada
20 May 2020 - Searchlight Pharma's new drug submission for a novel combined oral contraceptive accepted for review by Health Canada. ...