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- European Medicines Agency (EMEA)

European Medicines Agency (EMEA) Newsletter

15th industry stakeholder platform on research and development support, European Medicines Agency, Amsterdam, the Netherlands, from 4 December 2025, 12:30 (CET) to 4 December 2025, 17:30 (CET) 05 Nov 2025 00:14 GMT
This is the fifteenth in a series of regular meetings between regulators and representatives of industry stakeholder organisations. It addresses all areas of evidence generation along the medicine’s life-cycle and related to development support activities, …
Fourth European Medicines Agency - Medtech Europe bilateral meeting, European Medicines Agency, Amsterdam, the Netherlands, 21 November 2025 04 Nov 2025 13:42 GMT
This meeting is organised in the context of the EMA annual bilateral meetings with industry stakeholder organisations. The purpose of the meeting is to exchange views and promote dialogue on topics of common interest.
Global Regulatory Gridlock Hinders Biosimilar Savings, Expert Panel Warns 05 Nov 2025 01:36 GMT
… authorities (like the FDA or European Medicines Agency). By relying on external reviews …
Amitkumar Patel’s topical formulation mastery sets new industry standards for patient access 05 Nov 2025 04:38 GMT
… align international project management with European Medicines Agency, Medicines and Healthcare Products Regulatory …
<![CDATA[New data from Sweden highlight lesion features that accelerate GA growth]]> 04 Nov 2025 21:09 GMT
… was considered inadequate by the European Medicines Agency, which resulted in the rescinding …
Acetaminophen safety backed by science 04 Nov 2025 17:36 GMT
… Gynecologists, the European Union’s European Medicines Agency, the American Academy of Pediatrics …
United States Oncology Biosimilars Market is expected to reach US$ 30.83 Billion by 2033 | DataM Intelligence 04 Nov 2025 13:46 GMT
… regulatory framework, led by the European Medicines Agency (EMA), has enabled the early …
Praxis announces accelerated development path for relutrigine in SCN2A and SCN8A DEE patients following positive FDA feedback 04 Nov 2025 13:00 GMT
… (BTD), and ODD from the European Medicines Agency for the treatment of SCN2A …
Harmony Biosciences Reports Strong Q3 2025 Financial Results; Recently Raised 2025 Revenue Guidance to $845-$865M 04 Nov 2025 13:02 GMT
… Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of …
Vir Biotechnology concludes Eclipse 1 Phase III trial enrolment for CHD 04 Nov 2025 12:49 GMT
… this combination. In addition, the European Medicines Agency granted priority medicines (PRIME) and …

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