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 ...

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

The Food and Drug Administration is suspending a quality control program for testing of fluid milk and other dairy products ...

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, ...

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

Crofelemer, a novel plant-based anti-secretory prescription drug, has been granted Orphan Drug Designation by the FDA and the European Medicines ...

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

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 ...

Biogen BIIB and partner Eisai announced that the European Commission (EC) has granted marketing authorization to Leqembi ...

CHMP reversed its initial recommendation for the EC to not authorize the drug due to the risk of side effects like ARIA.