Health Canada releases What We Heard Report from the public engagement on the National Strategy for Drugs for Rare Diseases

26 July 2021 - Too many Canadians are struggling to access the drugs they need, especially if they have a rare ...

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BeiGene announces approval in Canada of Brukinsa (zanubrutinib) for the treatment of patients with mantle cell lymphoma

26 July 2021 - Second approval for BTK inhibitor Brukinsa in Canada. ...

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New treatment authorised and available for Canadians with HER2 positive breast cancer

20 July 2021 - Phesgo, a fixed dose combination of pertuzumab and trastuzumab for subcutaneous injection combines two treatments into ...

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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 ...

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Health Canada approves Vyxeos, the first chemotherapy advance in over 40 years for adults with high-risk acute myeloid leukaemia

7 July 2021 - Jazz Pharmaceuticals today announced the Health Canada approval and availability of Vyxeos (daunorubicin and cytarabine liposome for ...

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Knight Therapeutics announces Health Canada approval for Nerlynx (neratinib) to treat HER2 positive metastatic breast cancer

6 July 2021 - Knight Therapeutics announced today that Health Canada has approved Nerlynx (neratinib) in combination with capecitabine for the ...

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Médunik Canada once again receives Notice of Compliance from Health Canada for Ruzurgi (amifampridine) following review ordered by court ruling

29 June 2021 - Médunik Canada is pleased to announce that Health Canada has reissued the approval (Notice of Compliance) ...

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Medexus receives Notice of Compliance to commercialise Treosulfan in Canada

28 June 2021 - Medexus Pharmaceuticals today announced that it has received a Notice of Compliance from Health Canada to ...

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In an about face, Health Canada allows a controversial rare disease drug back on the market

26 June 2021 - In yet another twist in a complicated tale, Health Canada has reinstated approval of a rare ...

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Notice of Compliance with Conditions granted for Retevmo (selpercatinib), the first therapy in Canada specifically for patients with advanced RET driven lung and thyroid cancers

21 June 2021 - Conditional marketing authorisation based on data from LIBRETTO-001 Phase 1/2, the largest trial ever reported in patients ...

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Cystic fibrosis life-altering drug nearing patient access across the country: Health Canada

20 June 2021 - For the cystic fibrosis community, persistence and constant belief are paying off. ...

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Health Canada grants marketing authorisation for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in people ages 12 and older who have at least one F508del mutation

18 June 2021 - Approximately 1,100 F/MF patients now eligible for a CFTR modulator to treat the underlying cause of their ...

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Dupixent (dupilumab) pre-filled pen now available in Canada, providing convenient self-administration option for people with type 2 inflammatory diseases

17 June 2021 - The pre-filled pen offers an additional administration option for all Dupixent indications in patients aged 12 years ...

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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. ...

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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 ...

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