European Union — European Medicines Agency & United States — Food and Drug Administration
12 shared events · Importance 8 · Last updated May 07, 2026
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European Union — European Medicines Agency: The European Union — European Medicines Agency has released detailed guidance on computerized systems and data management, stressing the importance of secure, attributable and contemporaneous records, which accelerates the move toward automation.
United States — Food and Drug Administration: The United States — Food and Drug Administration encourages the adoption of advanced manufacturing technologies and continuous production models, reinforcing the shift from reactive to proactive compliance strategies in the pharmaceutical industry.
Apr 07, 2026 · 8 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency accepted the Marketing Authorization Application for Cevira, leading to milestone payments for Photocure.
United States — Food and Drug Administration: The United States — Food and Drug Administration provided clarity on the reclassification pathway for OAY-related equipment, which is expected to create a larger commercial opportunity for Photocure in the U.S. market.
May 07, 2026 · 6 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency was mentioned in GSK plc's alleged false statements regarding its independent conclusion on the causal association between ranitidine therapy and cancer.
United States — Food and Drug Administration: The United States — Food and Drug Administration was mentioned in GSK plc's alleged false statements regarding its independent conclusion on the causal association between ranitidine therapy and cancer.
Feb 10, 2025 · 34 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency authorized Oryzon Genomics to initiate the IDEAL Phase II trial for iadademstat in essential thrombocythemia.
United States — Food and Drug Administration: Oryzon Genomics is working on resubmitting the PORTICO-2 Phase III trial protocol for vafidemstat following feedback from the United States — Food and Drug Administration.
May 14, 2026 · 6 articles
Business
European Union — European Medicines Agency: A marketing application for BeOne Medicines' Next-Generation BCL-2 Inhibitor has been submitted to the European Union — European Medicines Agency, and it sets manufacturing standards for BeOne Medicines' Suzhou facility.
United States — Food and Drug Administration: The United States — Food and Drug Administration granted Priority Review to BeOne Medicines' Next-Generation BCL-2 Inhibitor and sets manufacturing standards for BeOne Medicines' Suzhou facility.
May 11, 2026 · 6 articles
Business
European Union — European Medicines Agency: The European Union — European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of Dupixent for chronic spontaneous urticaria (CSU) in the European Union.
Feb 24, 2026 · 8 articles
Tech
European Union — European Medicines Agency: The European Union — European Medicines Agency's Committee for Orphan Medicinal Products provided a positive opinion for Etavopivat, leading to its Orphan Drug designation by the International — European Commission.
Apr 20, 2026 · 7 articles
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