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RSS FeedPosted 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. ...
Posted by Michael Wonder on 13 Apr 2020
Gilead Canada submits supplemental new drug submission to Health Canada for Descovy for HIV pre-exposure prophylaxis
9 April 2020 - Submission supported by data from the DISCOVER trial, which evaluated the safety and efficacy of Descovy compared ...
Posted by Michael Wonder on 24 Jan 2020
HLS Therapeutics files new drug submission for Perseris in Canada
23 January 2020 - If approved by Health Canada, Perseris would become the first once-monthly risperidone long-acting injectable used in the ...
Posted by Michael Wonder on 04 Dec 2019
Health Canada grants priority review status for Heron Therapeutics' new drug submission for HTX-011 for management of post-operative pain
3 December 2019 - Heron Therapeutics today announced that Heron's new drug submission for HTX-011 for the management of postoperative pain ...
Posted by Michael Wonder on 20 Nov 2019
Medexus granted priority review status for Gliolan by Health Canada
19 November 2019 - Medexus Pharmaceuticals today announced that Health Canada has granted priority review status for the new drug ...
Posted by Michael Wonder on 15 Nov 2019
Valeo Pharma announces filing of a new drug submission for low molecular weight heparin in Canada
14 November 2019 - Valeo Pharma announced today that the new drug submission filed for a low molecular weight heparin ...
Posted by Michael Wonder on 27 Jun 2019
Knight announces filing of new drug submission for Ibsrela in Canada
26 June 2019 - Knight Therapeutics announced today that Knight's new drug submission for Ibsrela (tenapanor) has been accepted for ...
Posted by Michael Wonder on 11 Jun 2019
Duchesnay is seeking Health Canada's approval for ospemifene for the treatment of moderate to severe dyspareunia and vaginal dryness, symptoms of vulvar and vaginal atrophy, a component of genitourinary syndrome of menopause
10 June 2019 - Duchesnay has filed a new drug submission with Health Canada for a once-daily oral ospemifene tablet, ...
Posted by Michael Wonder on 30 Apr 2019
New drug submission filed for Vascepa with Health Canada
29 April 2019 - Amarin Corporation today announced that its licensee in Canada, HLS Therapeutics has filed a new drug ...
Posted by Michael Wonder on 16 Apr 2019
Recordati to seek Canadian approval for kidney disease drug
17 April 2019 - Italy’s Recordati said on Tuesday it plans to seek Canadian approval for its drug Cystagon, which ...