Canada — Health Canada & United States — Food and Drug Administration
22 shared events · Importance 5 · Last updated Aug 11, 2026
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Regulatory
Canada — Health Canada: Canada — Health Canada authorized VueJect under Medical Device License No. 115637, permitting its sale in Canada.
United States — Food and Drug Administration: The FDA granted 510(k) clearance for VueJect, a key regulatory step that allows Bracco to market the device in the United States.
Aug 11, 2026 · 7 articles
Tech
Canada — Health Canada: Canada — Health Canada>>> has not yet received an application to license daraxonrasib in Canada>>>. Its role is to regulate and approve new drugs for use in the country, impacting the timeline for Canadian patient access.
United States — Food and Drug Administration: The United States — Food and Drug Administration is expediting the review of daraxonrasib and has allowed expanded access to the drug, indicating its critical role in bringing this new treatment to patients.
May 29, 2026 · 74 articles
Business
Canada — Health Canada: Canada — Health Canada's regulation of ibogaine under the Food and Drugs Act and its listing on the Prescription Drug List provides a favorable regulatory environment for Optimi Health's operations.
United States — Food and Drug Administration: The United States — Food and Drug Administration's accelerated review process for psychedelic therapies, including ibogaine, is a key factor driving market interest and potential for new treatments.
Jun 08, 2026 · 14 articles
Business
Canada — Health Canada: Diagnosis is pursuing regulatory clearance with Canada — Health Canada>>> for its CARA platform, a key milestone for market expansion in Canada.
United States — Food and Drug Administration: Diagnosis completed a pre-submission process with the United States — Food and Drug Administration>>> in 2025, establishing a pathway for future 510(k) clearance in the United States.
Jun 05, 2026 · 11 articles
Regulatory
Canada — Health Canada: Canada — Health Canada granted a Class II medical device licence to Diagnosis for the CARA System, marking a regulatory approval.
United States — Food and Drug Administration: Diagnosis plans to submit CARA System application to FDA by September 2026; a legacy version is already cleared in the U.S.
Jul 27, 2026 · 6 articles
Regulatory
Canada — Health Canada: Canada — Health Canada provided scientific advice on the trial design, consistent with its regulatory role; no direct impact on the agency.
United States — Food and Drug Administration: The FDA provided scientific advice on the trial design, consistent with its regulatory role; no direct impact on the agency.
Jul 06, 2026 · 6 articles
Business
Canada — Health Canada: Canada — Health Canada is the regulatory body whose approval is required for Medexus Pharmaceuticals to begin commercializing Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel in Canada.
United States — Food and Drug Administration: The United States — Food and Drug Administration has granted orphan drug designation and regenerative medicine advanced therapy (RMAT) designations to Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel.
Jun 10, 2026 · 6 articles
Business
Canada — Health Canada: Canada — Health Canada provides supportive regulatory frameworks that facilitate product approvals and market growth in Canada.
United States — Food and Drug Administration: The US FDA provides supportive regulatory frameworks that facilitate product approvals and market growth in North America.
Jul 28, 2026 · 6 articles
Business
Canada — Health Canada: Canada — Health Canada approval for Kane's products enables commercial sales in Canada, contributing to the company's market presence.
United States — Food and Drug Administration: The FDA's 510(k) clearance for Kane's products supports its commercial activities and adds credibility to the company's growth prospects.
Aug 05, 2026 · 7 articles
Regulatory
Canada — Health Canada: Canada — Health Canada has licensed PMX for therapeutic use, indicating its approval in Canada.
United States — Food and Drug Administration: The United States — Food and Drug Administration completed its filing review and formally filed Spectral Medical's Premarket Approval application for PMX, initiating the substantive review phase.
Jun 25, 2026 · 6 articles
Business
Canada — Health Canada: Canada — Health Canada approved WYNZORA in December 2025, a regulatory prerequisite for the launch.
United States — Food and Drug Administration: The FDA approved WYNZORA in the US in 2020, but is not directly involved in the Canadian launch.
Aug 20, 2026 · 6 articles
Tech
Canada — Health Canada: Canada — Health Canada previously approved REDEMPLO (plozasiran), contributing to its international market presence.
United States — Food and Drug Administration: The United States — Food and Drug Administration previously approved REDEMPLO (plozasiran) and granted it Breakthrough Therapy designation for severe hypertriglyceridemia, indicating its regulatory significance.
May 26, 2026 · 6 articles
Tech
Canada — Health Canada: Canada — Health Canada is mentioned as having approved the SynCardia Total Artificial Heart, indicating regulatory validation in Canada.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is mentioned as having approved the SynCardia Total Artificial Heart, indicating regulatory validation.
Jun 16, 2026 · 6 articles
Business
Canada — Health Canada: Innovotech's operations are aligned with regulatory expectations such as those of Canada — Health Canada, which is a positive for the company's credibility.
United States — Food and Drug Administration: Innovotech's operations are aligned with regulatory expectations such as those of the U.S. United States — Food and Drug Administration, which is a positive for the company's credibility.
Jun 24, 2026 · 7 articles
Tech
Canada — Health Canada: Canada — Health Canada is mentioned as having approved AGAMREE for Duchenne muscular dystrophy in Canada, indicating the drug's established regulatory status.
United States — Food and Drug Administration: The United States — Food and Drug Administration is mentioned as having approved AGAMREE for Duchenne muscular dystrophy in the U.S., indicating the drug's established regulatory status.
Jul 01, 2026 · 6 articles
Regulatory
Canada — Health Canada: Previously approved the vaccine; not directly involved in this submission.
United States — Food and Drug Administration: Previously approved the vaccine; not directly involved in this submission.
Jul 13, 2026 · 6 articles
Business
Canada — Health Canada: Canada — Health Canada previously approved SynCardia's artificial heart; not directly involved in the stock split.
United States — Food and Drug Administration: FDA previously approved SynCardia's artificial heart; not directly involved in the stock split.
Jul 22, 2026 · 7 articles
Business
Canada — Health Canada: Canada — Health Canada approved AGAMREE in Canada; not directly involved in this expansion.
United States — Food and Drug Administration: The FDA approved AGAMREE in the U.S.; not directly involved in this distribution expansion.
Jul 13, 2026 · 6 articles
Regulatory
Canada — Health Canada: Canada — Health Canada is the regulatory body in Canada to which Diagnosis plans to submit CARA for approval, impacting its commercialization in Canada.
Apr 08, 2026 · 6 articles
Business
Canada — Health Canada: Canada — Health Canada had licensed MyndTec's MyndMove system, indicating its prior regulatory approval.
Apr 08, 2026 · 6 articles
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