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

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 ...

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 ...

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.

Sakar Healthcare Ltd ( ($IN:SAKAR) ) has shared an announcement. Sakar Healthcare Ltd announced that its oncology manufacturing site has been ...

Telix Pharmaceuticals recently confirmed that Part 1 of its ProstACT Global Phase 3 trial of TLX591 in metastatic castration-resistant prostate cancer has completed enrolment and that the study has ...

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 ...