Patients are losing out on life-changing drugs for cancer and rare diseases because of Brexit, experts have warned.

A group of expert neurologists have expressed concerns at the European Commission’s (EC) decision to formally approve the Alzheimer’s drug lecanemab (Leqembi) despite uncertain benefits. Lecanemab, ...

From protecting against infections for people who had a solid organ or bone marrow transplant to treating hepatitis B ...

Raw material dependency and transport bottlenecks, not just production capacity, are the key challenges facing the EU's ...

Short Summary The EU, UK, and USA each have distinct and evolving regulatory systems for medicines and medical devices, involving strict approval, surveillance, and market access requirements managed ...

Sarfaraz K. Niazi, PhD, shares his latest citizen's petition to the FDA, calling on the agency to waive clinical efficacy ...

The European Commission said Wednesday that it had given formal approval for Leqembi, a long-awaited new treatment for ...

Shares of Ascendis Pharma (ASND) are down $5.82, or 4%, to $155.33 in morning trading in New York. The move lower began near the open and may ...

Eisai and Biogen can finally put their European regulatory uncertainty surrounding Alzheimer's disease medicine Leqembi ...