Blog
RSS FeedPosted by Michael Wonder on 11 Jul 2022
Arcutis Biotherapeutics announces Health Canada accepts for review the new drug submission for roflumilast cream for adults and adolescents with plaque psoriasis
11 July 2022 - Submission supported by positive clinical data from the pivotal Phase 3 DERMIS-1 and DERMIS-2 clinical studies, as ...
Posted by Michael Wonder on 06 Jul 2022
Regulatory submission for GSK's daprodustat accepted into Health Canada review
6 July 2022 - Canadian regulatory submission acceptance follows that of the US FDA and the EMA as well as ...
Posted by Michael Wonder on 06 Jul 2022
Health Canada approves HyQvia, a new treatment for Canadians with immune deficiencies
6 July 2022 - New immunoglobulin treatment offers Canadian patients option of subcutaneous once-monthly (every three or four weeks) dosing. ...
Posted by Michael Wonder on 05 Jul 2022
Sandoz Canada expands its generics portfolio with three new products
5 July 2022 - Generic medicines like these three products help make effective medicine more affordable and accessible for Canadians and ...
Posted by Michael Wonder on 05 Jul 2022
Health Canada approves the use of Cibinqo (abrocitinib) for the treatment of patients 12 years of age and older with moderate-to-severe atopic dermatitis
4 July 2022 - Pfizer Canada announces today that Health Canada has approved Cibinqo (abrocitinib) for the treatment of patients 12 ...
Posted by Michael Wonder on 28 Jun 2022
Health Canada approves Opdivo (nivolumab) as monotherapy for the adjuvant treatment of adults with urothelial carcinoma at high risk of recurrence after undergoing radical resection of urothelial carcinoma
28 June 2022 - First adjuvant Immunotherapy for patients at high risk of disease recurrence. ...
Posted by Michael Wonder on 24 Jun 2022
Health Canada expands approval of Enhertu for adults with HER2 positive metastatic breast cancer
23 June 2022 - Approval based on the ground-breaking DESTINY-Breast03 Phase 3 trial, showing Enhertu reduced the risk of disease ...
Posted by Michael Wonder on 23 Jun 2022
Maviret (glecaprevir/pibrentasvir) approved by Health Canada for paediatric patients with chronic hepatitis C
22 June 2022 - This approval is supported by 98.4 per cent cure rate across this group of patients who ...
Posted by Michael Wonder on 19 Jun 2022
Canadian regulator OKs Hugel's botulinum toxin product
16 June 2022 - Hugel said Thursday that it has obtained product approval from Health Canada for its botulinum toxin ...
Posted by Michael Wonder on 13 Jun 2022
Amylyx Pharmaceuticals announces Health Canada approval of Albrioza for the treatment of ALS
13 June 2022 - Health Canada decision signifies the first global regulatory approval for Amylyx and the first new therapy for ...
Posted by Michael Wonder on 08 Jun 2022
Health Canada approves Tabrecta: targeted cancer therapy for locally advanced unresectable or metastatic non-small cell lung cancer (NSCLC) harbouring mesenchymal-epithelial transition (MET) exon 14 skipping alterations
8 June 2022 - Newest treatment for lung cancer reinforces Novartis commitment to developing innovative therapies that improve outcomes for ...
Posted by Michael Wonder on 08 Jun 2022
The UK MHRA, Australian TGA and Health Canada approve Kimmtrak (tebentafusp) for the treatment of unresectable or metastatic uveal melanoma
8 June 2022 - Kimmtrak demonstrated statistically and clinically meaningful overall survival benefit, hazard ratio of 0.51, with median overall survival ...
Posted by Michael Wonder on 08 Jun 2022
Forus Therapeutics announces Xpovio (selinexor) is authorised for sale by Health Canada
7 June 2022 - FORUS Therapeutics is pleased to announce that on 31 May 2022, Xpovio (selinexor) was authorised for ...
Posted by Michael Wonder on 06 Jun 2022
BioCryst announces Health Canada has authorised Orladeyo (berotralstat), the only oral treatment for the prevention of hereditary angioedema attacks
6 June 2022 - BioCryst Pharmaceuticals today announced that Health Canada has approved oral, once daily Orladeyo (berotralstat) for the ...
Posted by Michael Wonder on 02 Jun 2022
Health Canada OKs Pfizer COVID-19 booster shot for teens ages 16 and 17
1 June 2022 - Canada on Wednesday authorised a single booster shot of Pfizer and partner BioNTech’s COVID-19 vaccine for ...