United Kingdom & United States — Food and Drug Administration
50 shared events · Importance 10 · Last updated Aug 21, 2026
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Regulatory
United Kingdom: The UK is the site of the NHS-Galleri trial, providing key clinical data supporting the PMA application. Approval could influence UK adoption.
United States — Food and Drug Administration: The FDA is the regulatory authority reviewing the PMA application. Its decision will determine Galleri's market availability in the U.S.
Aug 07, 2026 · 6 articles
Regulatory
United Kingdom: Relfydess (RelabotulinumtoxinA) is already approved and launched in the United Kingdom, indicating that the regulatory issues in the United States do not affect its status in this region.
United States — Food and Drug Administration: The United States — Food and Drug Administration issued a Complete Response Letter to Galderma Group for RelabotulinumtoxinA, citing observations during a manufacturing site inspection and analytical method optimization, which delays the product's approval in the United States.
Jul 01, 2026 · 6 articles
Tech
United Kingdom: The United Kingdom is mentioned in the context of dementia prevalence and the potential future availability of these diagnostic tools on the NHS, highlighting its interest in adopting these advancements.
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
Tech
United Kingdom: The United Kingdom is urged to make clinical trials for Daraxonrasib available and fast-track its approval to benefit 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
Business
United Kingdom: AVT05, AVT06, and AVT03 have already been approved in the United Kingdom>>>, demonstrating their market acceptance outside the United States>>>.
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
United Kingdom: The HIVEC HEAT trial is being conducted across 25 sites in the United Kingdom.
United States — Food and Drug Administration: The HIVEC HEAT trial aims to generate clinical data to support United States — Food and Drug Administration registration for Combat Medical's bladder recirculation system.
May 27, 2026 · 6 articles
Regulatory
United Kingdom: The United Kingdom is the first country where INmune Bio Inc. has received a key regulatory approval for Ebstrocel, paving the way for a Marketing Authorization Application (MAA) and potential market access for patients with Recessive Dystrophic Epidermolysis Bullosa (RDEB).
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is a target for a Biologics License Application (BLA) submission in early 2027 for INmune Bio Inc.'s CORDStrom platform, indicating future regulatory efforts in the United States. The FDA also granted Fast Track designation for XPro1595.
Jun 25, 2026 · 6 articles
Business
United Kingdom: One of the countries where IV maintenance dosing is approved.
United States — Food and Drug Administration: Approved Leqembi Iqlik on July 13, enabling the US launch.
Aug 24, 2026 · 6 articles
Tech
United Kingdom: The UK's NHS would need to approve the treatment for availability, and UK experts commented on the results.
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
United Kingdom: The United Kingdom participated in the PAES study, contributing to the data that supports the efficacy and safety of Imlifidase.
United States — Food and Drug Administration: The United States — Food and Drug Administration accepted the Biologics License Application for imlifidase in February 2026, indicating potential future market expansion for the drug in the US.
May 27, 2026 · 6 articles
Business
United Kingdom: The UK is included in the licensed territories, and Tenpoint has already submitted a marketing application there, indicating regulatory progress.
United States — Food and Drug Administration: The FDA's approval of YUVEZZI is a prerequisite for its U.S. commercialization and adds credibility to the product.
Aug 20, 2026 · 12 articles
Regulatory
United Kingdom: The UK has already granted marketing authorization for CAM2029 (Oczyesa), providing a reference for the US review.
United States — Food and Drug Administration: The FDA accepted the resubmission for review and set a PDUFA date; its regulatory decision will determine market access for CAM2029 in the US.
Jul 17, 2026 · 6 articles
Business
United Kingdom: The United Kingdom>>> is one of the regions where SERB Pharmaceuticals>>> will acquire rights to Imlifidase>>>.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> accepted the Biologics License Application for imlifidase in the US, indicating future market potential outside the current deal.
May 19, 2026 · 7 articles
International
United Kingdom: The United Kingdom is facing political uncertainty with a special election that could determine its next prime minister and the resignation of its defense secretary over military spending concerns.
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
United Kingdom: The acquired manufacturing platform supplies into multiple global markets including the United Kingdom, 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
Tech
United Kingdom: The United Kingdom is mentioned as a country where Melatonin is only available by prescription, contrasting with its over-the-counter status in the United States.
United States — Food and Drug Administration: The United States — Food and Drug Administration does not regulate Melatonin as a drug in the United States, which means manufacturers are not subject to the same scrutiny as prescription medications.
Nov 03, 2025 · 6 articles
Business
United Kingdom: The United Kingdom is one of the countries where additional regulatory filings are planned for Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel.
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
United Kingdom: The United Kingdom is the base for LifeArc, a key partner in this collaboration, and a focus region for the advancement of the gene therapy programs.
United States — Food and Drug Administration: FDA approval is a critical milestone for Elpida Therapeutics' SPG50 gene therapy, with an ambition to achieve it by early 2028.
May 27, 2026 · 6 articles
Business
United Kingdom: United Kingdom is one of the international markets where CannEpil has been authorized for importation and prescription through the Named Patient Request framework.
United States — Food and Drug Administration: United States — Food and Drug Administration has engaged with the CannEpil program through the pre-IND process and assigned an Investigational New Drug (IND) number, laying the foundation for future U.S. clinical development.
Jul 06, 2026 · 6 articles
Business
United Kingdom: The UK is one of the regulated markets served by the company, part of its global footprint.
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
Regulatory
United Kingdom: The U.K. is the home country of the MHRA; 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
United Kingdom: Recently introduced a four-in-one MMRV vaccine, showing a trend toward combination shots, not separation.
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
Business
United Kingdom: MiNK Therapeutics has commenced commercial launch of LYTENAVA (bevacizumab gamma) in the United Kingdom.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) granted MiNK Therapeutics' appeal, concluding that substantial evidence of effectiveness has been established for LYTENAVA, and will now review the resubmitted BLA with a decision expected within 60 days.
May 26, 2026 · 7 articles
Business
United Kingdom: The U.K. approved PEDMARQSI in October 2023, allowing marketing in the U.K. This event does not involve new U.K. regulatory actions.
United States — Food and Drug Administration: The FDA approved PEDMARK in September 2022, which is a key regulatory milestone for Fennec. This event does not involve new FDA actions.
Aug 05, 2026 · 6 articles
Business
United Kingdom: The United Kingdom is one of the countries where MiNK Therapeutics has commenced commercial launch of LYTENAVA. The offering does not directly affect the UK.
United States — Food and Drug Administration: The FDA approved LYTENAVA for the treatment of wet AMD. The offering does not directly affect the FDA.
Aug 12, 2026 · 7 articles
Tech
United Kingdom: Heart attacks and strokes are leading causes of death in the United Kingdom>>>, highlighting the global relevance and potential impact of VERVE-102.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> granted Fast Track designation to VERVE-102, indicating its recognition of the therapy's potential to address an unmet medical need.
May 26, 2026 · 12 articles
Business
United Kingdom: The UK is one of the markets where Idefirix is conditionally approved, part of the product's European footprint.
United States — Food and Drug Administration: The FDA's acceptance of the BLA and PDUFA date of December 19, 2026, are key upcoming regulatory milestones for GT Biopharma in the US market.
Aug 18, 2026 · 6 articles
Accidents
United Kingdom: The United Kingdom>>> is one of multiple nations that have implemented travel restrictions in response to the Ebola outbreak, indicating a global concern.
United States — Food and Drug Administration: The United States — Food and Drug Administration has approved Inmazeb, a combination of antibodies, to treat Zaire Ebolavirus infection, which Regeneron Pharmaceuticals has donated for potential use in the current outbreak.
May 18, 2026 · 505 articles
Tech
United Kingdom: The United Kingdom is the source of the Biobank data used in the study, providing a large participant pool for the research.
United States — Food and Drug Administration: Mentioned for caffeine intake recommendations, not directly involved.
Jun 30, 2026 · 21 articles
Tech
United Kingdom: Millions of people in the United Kingdom>>> are affected by difficult-to-treat Depression (mood)>>>, making this research particularly relevant for the country's healthcare.
United States — Food and Drug Administration: The United States — Food and Drug Administration>>> (FDA) has approved Tocilizumab>>> for other conditions, providing a regulatory precedent for the drug.
May 20, 2026 · 9 articles
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