While it may have been a chaotic year for the US Food and Drug Administration (FDA) due to layoffs, leadership changes and ...
Novo Nordisk A/S (NYSE:NVO) is one of the Best Non-US Stocks to Buy According to Hedge Funds. On December 12, Novo Nordisk ...
The application is based on the successful outcome of the pivotal US Phase 3 ConfIdeS trial in highly sensitized patientsImlifidase is an enzyme that rapidly and efficiently cleaves all types of ...
As neurological conditions expose the limits of traditional clinical endpoints, Europe’s regulators are being pushed to ...
This effort to accelerate development can be clearly seen in how the agency is approaching biosimilars. In October 2025, the FDA issued a guidance update indicating that “switching” studies — a trial ...
On Dec. 19, 2025, Emer Cooke, executive director of the European Medicines Agency (EMA), published highlights of the agency’s accomplishments in 2025, which marked three decades since its inception.
Guselkumab has received approval for moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.1The decision is supported by the ...
Experts behind the research from the Centre for Cooperative Research in Biomaterials in San Sebastián, urged officials to ...
Bracco Imaging S.p.A., a global leader in diagnostic imaging, announces that on 11 December 2025 the Committee for Medicinal ...
Discover the EMA's role in promoting safe medicine access in the EU. Learn about its responsibilities in drug evaluation, ...
EMA validates Type II Variation marketing authorization application of Datroway as first-line treatment for patients with metastatic TNBC who are not candidates for immunotherapy ...
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