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. ...

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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. ...

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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 ...

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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 ...

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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. ...

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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, ...

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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 ...

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Janssen seeks Health Canada approval for its COVID-19 vaccine

1 December 2020 - Regulator currently evaluating data from 4 vaccine makers. ...

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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 ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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. ...

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