Australia & United States — Food and Drug Administration
10 shared events · Importance 9 · Last updated Jul 01, 2026
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Regulatory
Australia: Relfydess (RelabotulinumtoxinA) is already approved and launched in Australia, 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
Business
Australia: Australia is one of the international markets where CannEpil has been made available.
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
Australia: Australia is the home country of Orthocell and several corporate donors supporting the humanitarian effort.
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
Tech
Australia: Australia provided real-world registry data for one of the indirect treatment comparison studies, where vorinostat is part of the standard of care.
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) is mentioned as an entity to which suspected adverse reactions to POTELIGEO can be reported.
Jun 30, 2026 · 6 articles
Business
Australia: Australia is a market where Norgine commercializes PEDMARQSI.
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
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