2 deaths after giving plasma in Winnipeg not linked to donation process: Health Canada

The federal health regulator said Friday its assessment found no evidence of a machine malfunction and the equipment ...

Apotex Strengthens Osteoporosis Care in Canada with Health Canada's Approval of DENOZA™, a Denosumab Biosimilar

Apotex Inc. ("Apotex" or the "Company"), the largest Canadian‑based global pharmaceutical company, today announced that Health Canada has approved DENOZA™ (denosumab injection), a biosimilar ...

Health Canada slaps new conditions on plasma donation company Grifols, still reviewing 2 Winnipeg deaths

Health Canada has slapped new terms and conditions on all of a company's paid plasma centres after multiple failed ...
JD Supra

Proposed Changes to the Guidance on Recognized Standards for Medical Devices in Canada

Changes affecting the approval of medical devices in Canada are coming. Health Canada has released a notice on Proposed Changes to the Guidance on Recognized Standards for Medical Devices along with a ...
JD Supra

Health Canada publishes guidance on submitting risk management plans

As we previously reported, agile licensing amendments to the Food and Drug Regulations and Medical Devices Regulations were registered on November 29, 2024. We are continuing to update our previous ...
Business Wire

Health Canada approves Celltrion’s Omlyclo™ (CT-P39), the first and only omalizumab biosimilar in Canada

“Diseases such as CIU have substantial detrimental effects on the quality of life for patients, often impacting both their physical and emotional well-being. Over the last two decades, omalizumab has ...
The Conversation

Why drug approval in Canada should not rely on foreign regulators

Without much fanfare, Health Canada announced in the Canada Gazette Part 1 on Dec. 22, 2025 that it was beginning a 70-day consultation period on using the decisions of foreign drug regulators such as ...