United States — Food and Drug Administration & International — European Commission
10 shared events · Importance 7 · Last updated May 04, 2026
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United States — Food and Drug Administration: The United States — Food and Drug Administration previously approved Setmelanotide (setmelanotide) for acquired hypothalamic obesity in the United States, setting a precedent for the International — European Commission's authorization.
International — European Commission: The International — European Commission granted expanded marketing authorization for Setmelanotide (setmelanotide) for acquired hypothalamic obesity, enabling Rhythm Pharmaceuticals to commercialize the drug in Europe.
May 01, 2026 · 6 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) previously approved RYTELO (imetelstat), and the real-world study was conducted following this approval.
International — European Commission: The International — European Commission also approved RYTELO (imetelstat) for use in the European Union.
May 12, 2026 · 6 articles
Tech
United States — Food and Drug Administration: The United States — Food and Drug Administration (FDA) previously granted Orphan Drug Designation, Fast Track designation, and Breakthrough Therapy Designation to Revumenib (revumenib).
International — European Commission: The International — European Commission previously granted Orphan Drug Designation to Revumenib (revumenib) for the treatment of AML.
May 12, 2026 · 7 articles
Business
United States — Food and Drug Administration: The United States — Food and Drug Administration approved PEDMARK in September 2022, making it the first and only approved therapy to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients.
International — European Commission: The International — European Commission approved PEDMARQSI in June 2023, further expanding the market reach for Fennec Pharmaceuticals' product.
May 14, 2026 · 6 articles
Tech
International — European Commission: The International — European Commission granted Etavopivat Orphan Drug designation, based on a positive opinion from the Committee for Orphan Medicinal Products of the European Union — European Medicines Agency, which will facilitate its development and potential approval in Europe.
Apr 20, 2026 · 7 articles
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