Bracco Imaging S.p.A., a global leader in diagnostic imaging, announces that on January 23, 2026, the European Commission (EC ...
EMA and FDA have jointly issued guiding principles for the safe and responsible use of AI across the medicines life cycle, aiming to harmonize ...
Merz Therapeutics, a leading player in neurology-focused specialty pharma, today announced that it has completed the ...
The European regulator’s anniversary year featured first-in-class therapies, rare-disease advances, safety warnings, and new rules reshaping how medicines reach patients.
This is eight fewer than the FDA, which approved 46 novel drugs in 2025 – sneaking in two regulatory decisions during the ...
Jan 14 (Reuters) - The U.S. Food and Drug Administration and the European Medicines Agency jointly issued principles for safe and responsible use of artificial intelligence in developing medicines, ...
One Application Seeks European Commission Authorization; Other Application Would Facilitate Availability in Low- and Lower-Middle-Income Countries - - Both Applications Will Be Assessed in Parallel ...
The guiding principles of good AI practice in drug development are a first step of a renewed EU-US cooperation.
Acting Therapy for GBS, Setting a New Standard of Care BLA Submission with U.S./European Data from FORWARD Trial Planned in 2026 BRISBANE, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Annexon, Inc.
Among the health policy novelties of 2025, a new tool developed by the European Medicines Agency (EMA) is set to harmonise monitoring of medicine shortages across Europe. View on euronews ...
European legislators have reached a deal on a major rewrite of the region's pharma policies, pushing forward a framework aimed at boosting the bloc's competitiveness while strengthening supply chains.
The "A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU (European Union) and UK Training Course (Apr 29, 2026)" training has been added to ResearchAndMarkets.com's ...