Health Canada approves Zoladex LA for the management of oestrogen receptor positive early breast cancer with a high risk of recurrence or advanced breast cancer in pre- and peri-menopausal women

7 May 2024 - TerSera Canada today announced that Health Canada has approved a supplemental new drug submission for Zoladex LA ...

Read more →

Wegovy (semaglutide injection) available in Canada

2 May 2024 - First and only Health Canada approved once weekly medication for chronic weight management ...

Read more →

Velsipity receives Health Canada approval for adults with moderately to severely active ulcerative colitis

24 April 2024 - Velsipity is a once daily, oral, sphingosine 1-phosphate (S1P) receptor modulator that selectively binds with S1P ...

Read more →

Health Canada authorizes Tecentriq SC (atezolizumab solution for subcutaneous injection), the first cancer immunotherapy subcutaneous injection, for multiple cancer types

23 April 2024 - Roche Canada will be working closely with the pan-Canadian Pharmaceutical Alliance, as well as federal, provincial, ...

Read more →

Health Canada approves new indication for Merck’s Prevymis (letermovir) for prevention of cytomegalovirus disease in high risk adult kidney transplant recipients

19 April 2024 - Merck announced that Health Canada has approved a new indication for Prevymis (letermovir) for the prophylaxis ...

Read more →

Nora Pharma receives Health Canada approval for Niopeg, a biosimilar of Neulasta

19 April 2024 - Nora Pharma, a wholly owned division of Sunshine Biopharma, has received approval from Health Canada for the ...

Read more →

Health Canada approves Keytruda as a first-line treatment for adult patients with locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction adenocarcinoma in combination with fluoropyrimidine- and platinum-containing chemotherapy

19 April 2024 - Approval is based on the Phase 3 KEYNOTE-859 trial. ...

Read more →

Paladin Labs announces approval of Wakix (pitolisant hydrochloride tablets) for use in paediatric patients in Canada

28 March 2024 - Indication includes children ages 6 years and older and weighing at least 30 kg. ...

Read more →

Ferinject approved by Health Canada for the treatment of iron deficiency anaemia in adult and paediatric patients and iron deficiency in adult patients with heart failure

19 March 2024 - CSL Vifor today announced that Health Canada has authorised Ferinject (ferric carboxymaltose) for the intravenous treatment of ...

Read more →

Bimzelx (bimekizumab) now approved for adults with active psoriatic arthritis and for adults with axial spondyloarthritis

14 March 2024 - Health Canada's approval is supported by Phase III clinical trial data which found Bimzelx provided significant improvement ...

Read more →

AB Science announces that Health Canada has issued a notice of non-compliance-withdrawal for masitinib in ALS

26 February 2024 - AB Science today announces that Health Canada has issued a notice of non-compliance-withdrawal regarding its new ...

Read more →

Sandoz receives Health Canada approval for Jubbonti, first and only denosumab biosimilar for treatment of osteoporosis

20 February 2024 - Biosimilar Jubbonti approved for all indications of Prolia reference medicine. ...

Read more →

Health Canada approves Remsima SC for the treatment of inflammatory bowel disease

18 February 2024 - The approval is based on results from the LIBERTY studies demonstrating superior efficacy and comparable safety profiles ...

Read more →

Elrexfio is authorised by Health Canada for adults with relapsed or refractory multiple myeloma in Canada

13 February 2024 - Today, Pfizer Canada announced that Health Canada has granted a Notice of Compliance with conditions to Elrexfio ...

Read more →

Health Canada approves Keytruda in combination with trastuzumab and chemotherapy, as a first-line treatment for patients with locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma whose tumours express PD-L1

12 February 2024 - Approval is based on the Phase 3 KEYNOTE-811 Trial. ...

Read more →