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

Biotech stock Scholar Rock (NASDAQ: SRRK) was popular among investors on Wednesday after a positive new analyst note on the ...

Glucagon-like peptide 1 receptor agonists, which are found in Ozempic-like drugs, can could cause devastating symptoms in ...

Zimislecel is an allogeneic stem cell-derived islet cell therapy that could eliminate the need for insulin in those who have type 1 diabetes. Regulatory submissions are expected in 2026, and if ...

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, ...

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

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

Evercore ISI analyst Cory Kasimov says SpringWorks Therapeutics (SWTX)’ Ogsiveo is on today’s agenda for the European Medicines Agency’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 ...

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 ...