The pharmaceutical industry's next billion-dollar blockbuster won't come from a lab alone—it will come from listening to ...

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

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 ...

The voices, values and lived experience of people living with dementia - and their families - must shape the path forward for ...

The European Medicines Agency (EMA), after initial rejection based on an unfavourable risk-benefit balance, recently recommended approval of lecanemab for treating people with mild cognitive ...

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 ...

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

Crofelemer, a novel plant-based anti-secretory prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA) for both short bowel syndrome (SBS) and ...

The General Inspectorate of Health Activities (IGAS) has opened a clarification process regarding the marketing of the drug ...

The FDA did not agree with a supplemental Biologics License Application for the addition of extended dosing intervals of up ...

The European Commission on Tuesday authorized the use of Eisai and Biogen's drug to treat some patients with mild cognitive impairment in the early stages of Alzheimer's disease, ending a more than ...