The reassessment of Leqembi’s safety data follows the agency’s previous recommendation of the drug for use in the EU.

In the latest development, the European Commission has asked the EMA's human medicines committee, the CHMP, to take a look at ...

With thousands of press releases published each week, it can be difficult to keep up with everything on . To help healthcare ...

It was a busy week for the biotech sector, with regulatory and pipeline updates. Sage Therapeutics SAGE was in focus after it ...

This article highlights recent developments in healthcare, including the U.S. FDA's approval of Alzheimer's and diabetes ...

The Food and Drug Administration (FDA) has approved a new maintenance dosing schedule for Leqembi, a monoclonal antibody ...

Recent health news includes a profit boost for Swedish manufacturer Getinge, a human case of bird flu detected in the UK, and ...

The US Food and Drug Administration (FDA) has approved Eisai and Biogen’s Supplemental Biologics License Application for once ...

A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research ...

Biogen Inc. (BIIB) saw its stock climb 1.7% on Monday afternoon, reaching a nearly two-week high following positive ...

Access to the new Alzheimer's drugs is limited by strict eligibility criteria, long wait times, and a lack of infusion ...

Approval was based on results from multiple studies, which demonstrated a slowing of cognitive decline in patients with ...