United Kingdom & United States — Food and Drug Administration
21 shared events · Importance 18 · Last updated Jul 01, 2026
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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
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: 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
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 the source of the Biobank data used in the study, providing a large participant pool for the research.
United States — Food and Drug Administration: The United States — Food and Drug Administration is cited for its caffeine intake recommendations, offering guidance on safe consumption levels.
Jun 30, 2026 · 10 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: 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
International
United Kingdom: Regulatory approval for Remplir in the United Kingdom is expected in late 2026.
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
United Kingdom: The United Kingdom approved PEDMARQSI, a key product of Fennec Pharmaceuticals, and is a market where Norgine commercializes the product.
United States — Food and Drug Administration: The United States — Food and Drug Administration approved PEDMARK, a key product of Fennec Pharmaceuticals, which provides background on the company's operational success.
May 18, 2026 · 7 articles
Regulatory
United States — Food and Drug Administration: United States — Food and Drug Administration reassured the public that Nestlé infant formulae sold in Nigeria are safe and not part of the global recall initiated by Nestlé UK.
Jan 12, 2026 · 7 articles
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