Discover the EMA's role in promoting safe medicine access in the EU. Learn about its responsibilities in drug evaluation, ...

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 ...

While it may have been a chaotic year for the US Food and Drug Administration (FDA) due to layoffs, leadership changes and ...

As neurological conditions expose the limits of traditional clinical endpoints, Europe’s regulators are being pushed to ...

If finalized, the changes would reduce the scope of AI regulations for medical devices and include more provisions for rare ...

Bracco Imaging S.p.A., a global leader in diagnostic imaging, announces that on 11 December 2025 the Committee for Medicinal ...

Experts behind the research from the Centre for Cooperative Research in Biomaterials in San Sebastián, urged officials to ...

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 ...

The US FDA has approved depemokimab as an add-on maintenance therapy for individuals aged 12 years or older with severe asthma, according to a press release from manufacturer GlaxoSmithKline.

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 ...