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.

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

PRESS RELEASE Memo Therapeutics AG’s Potravitug Granted Orphan Designation in the European UnionOrphan designation confers market exclusivity, ...

ImmunityBio Inc. (NASDAQ: IBRX) is one of the best multibagger penny stocks to buy right now. On December 12, analysts at ...

Agreement underscores Norgine's mission to bring innovative therapies to patients and builds on our heritage in hepatology and specialty pharmaceuticals. -- Vir Biotechnology's chronic hepatitis delta ...

On the same day, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive ...

Although development of a jab for the H5N1 strain of avian flu is well under way, other strains are receiving less attention ...

Sanofi’s efdoralprin alfa earns orphan designation in the EU for alpha-1 antitrypsin deficiency related emphysemaAdditional orphan designation ...

EU Reaches Landmark Deal On Pharma Package. Legal News and Analysis - EU, Europe - Regulatory & Compliance - Conventus Law ...

Sanofi (EURONEXT: SAN) announced Wednesday that its investigational therapy, efdoralprin alfa, has received orphan drug ...