Canada & United States — Food and Drug Administration
41 shared events · Importance 12 · Last updated Aug 21, 2026
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Canada: Canada>>> is a primary focus of this event, with oncologists like Jennifer L. Knox>>> and Daniel Renouf>>> working to open clinical trials for daraxonrasib to benefit Canadian pancreatic cancer patients.
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
Regulatory
Canada: Canada is one of the initial markets where VueJect will be available following Canada — Health Canada authorization, potentially improving access to advanced cardiac imaging technology.
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
Business
Canada: Canada's regulatory environment, where ibogaine is not a controlled substance and Optimi Health has GMP infrastructure and Canada — Health Canada licensing, positions it as an advantageous base for ibogaine manufacture and supply.
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
Regulatory
Canada: Country of lead author's institution, contributing to the research.
United States — Food and Drug Administration: The FDA is the central regulator whose clearance process is criticized for not requiring outcome testing. The study could lead to policy changes affecting its approval pathways.
Aug 19, 2026 · 6 articles
Business
Canada: Canada is the country where Medexus Pharmaceuticals has secured exclusive commercialization rights for Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel, pending regulatory approval.
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
Tech
Canada: Canada>>> was one of the countries where the phase 3 clinical trial for AD 109>>> was conducted.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> has granted AD 109>>> Fast Track designation and is currently reviewing Apnimed's New Drug Application, with a decision expected in Q1 2027.
May 18, 2026 · 7 articles
Accidents
Canada: Canada is mentioned as having past outbreaks linked to similar produce, but is not directly involved in the current U.S. outbreak.
United States — Food and Drug Administration: The FDA is assisting in the outbreak investigation, focusing on food safety and potential contamination sources.
Jun 30, 2026 · 348 articles
Regulatory
Canada: Canada is the country where the Canada — Health Canada licence was granted, enabling commercialization in the Canadian optometry market.
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: Canada is reviewing the vaccine, potentially broadening its availability.
United States — Food and Drug Administration: The FDA granted approval for mFLUSIVA, marking a regulatory milestone and demonstrating its role in vaccine oversight despite internal controversies.
Aug 05, 2026 · 105 articles
Business
Canada: Canada, through Canada — Health Canada, contributes to the supportive regulatory environment in North America.
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: AVT06 has already been approved in Canada>>>, further expanding its international market reach.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> (FDA) is the regulatory body reviewing Alvogen's resubmitted applications for AVT05 and AVT06. Their decision will determine the market entry of these biosimilars in the United States>>>.
Jun 04, 2026 · 10 articles
Tech
Canada: Canada was one of the locations where the study on the new brain imaging test (MK6240) was conducted, contributing to the research findings.
United States — Food and Drug Administration: The United States — Food and Drug Administration has approved blood-based biomarker tests for symptomatic patients, indicating its role in regulating medical diagnostics.
May 28, 2026 · 8 articles
Accidents
Canada: Canada has imposed temporary import restrictions on livestock from United States — Texas due to the screwworm outbreak, impacting trade relations.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> granted emergency use authorization for several drugs to treat screwworm, aiding in the response to the outbreak.
Apr 20, 2026 · 190 articles
Business
Canada: Canada is included in the commercialization territory alongside the U.S., with potential for label expansion.
United States — Food and Drug Administration: The FDA is reviewing PolyPid's NDA for D-PLEX100, with acceptance expected in August 2026. The agency previously granted Breakthrough Therapy Designation for the product.
Jul 21, 2026 · 7 articles
Regulatory
Canada: Spectral Medical signed an exclusive distribution agreement for PMX 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
Tech
Canada: Canada is a potential market, with melanoma incidence and patient advocacy groups responding positively.
United States — Food and Drug Administration: The FDA will review the trial data for potential approval. The companies plan to file for approval, and the vaccine could be available as soon as 2027 if approved.
Aug 19, 2026 · 108 articles
Business
Canada: Canada is the market where WYNZORA is launched, providing a new treatment option for psoriasis patients.
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
Business
Canada: The acquired manufacturing platform supplies into multiple global markets including Canada, indicating its international reach.
United States — Food and Drug Administration: The acquired facilities have completed multiple United States — Food and Drug Administration inspections with clean results, indicating compliance with regulatory standards.
Jul 02, 2026 · 7 articles
Business
Canada: Health Canada accreditation is one of the regulatory approvals held by the company, supporting its market access.
United States — Food and Drug Administration: The USFDA accreditation is a key regulatory approval for the company, enabling access to the US market.
Aug 03, 2026 · 6 articles
Business
Canada: Canada is Kane's home market and another key market where commercial activities have commenced following Canada — Health Canada approval.
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
Business
Canada: Canada>>> is the location of Diagnosis's headquarters and a target market for its regulatory clearances.
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: Canada is the home country of Canada — Health Canada; no direct impact from this announcement.
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
Domestic
Canada: Similarly uses combination MMR, highlighting inconsistency in the administration's claims.
United States — Food and Drug Administration: Responsible for approving any new separate vaccines, a process that could take years. It faces pressure to review unbundled shots without precedent.
Aug 10, 2026 · 235 articles
International
Canada: Canada>>> joined a joint statement condemning Iran>>>'s attacks, demonstrating international diplomatic pressure.
United States — Food and Drug Administration: The United States — Food and Drug Administration is the regulatory body that Revolution Medicines will seek approval from for its experimental pancreatic cancer drug, daraxonrasib.
May 18, 2026 · 316 articles
Business
Canada: Canada is cited as a market where WK Kellogg has already removed artificial ingredients, serving as a precedent for the U.S. transition.
United States — Food and Drug Administration: The FDA's allowance of voluntary labeling claims about absence of certified colors supports companies like WK Kellogg in marketing their products as free of artificial dyes.
Aug 06, 2026 · 6 articles
Tech
Canada: Canada is where the first patient was enrolled for the global Phase 2 INFLO-2 study.
United States — Food and Drug Administration: The United States — Food and Drug Administration has previously approved Oracle Corporation's dry powder inhalation therapies, indicating a regulatory pathway for similar technologies.
Jun 03, 2026 · 6 articles
Regulatory
Canada: Canada was a trial site and is a potential market for the vaccine.
United States — Food and Drug Administration: The FDA is mentioned in the context of a separate approval for Pfizer's Hympavzi, not directly related to this event.
Aug 14, 2026 · 12 articles
International
Canada: Remplir is cleared for use and sale in Canada.
United States — Food and Drug Administration: The United States — Food and Drug Administration cleared Remplir for use in April 2025, which is a significant regulatory milestone for the device.
Jun 29, 2026 · 6 articles
Business
Canada: Profound Medical is headquartered in Canada and its products are cleared there.
United States — Food and Drug Administration: FDA has cleared TULSA-PRO and approved Sonalleve in the US.
Jul 16, 2026 · 7 articles
Regulatory
Canada: Country where trofinetide is already approved under the name DAYBUE.
United States — Food and Drug Administration: The FDA previously approved trofinetide in the US, establishing its efficacy and safety.
Aug 24, 2026 · 7 articles
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