The U.S. Food and Drug Administration (FDA) has approved monthly maintenance dosing for Leqembi (lecanemab), a treatment for early Alzheimer’s disease.

Zimmer Biomet Announces Definitive Agreement to Acquire Paragon 28 This proposed transaction further diversifies Zimm ...

An international clinical trial aimed at preventing Alzheimer’s disease (AD) in young adults who are at risk of developing ...

Children who inherit genetic mutations from parents with early-onset Alzheimer’s typically show signs of dementia at the same ...

The FDA has approved the sBLA for once every 4 weeks lecanemab-irmb (Leqembi®) intravenous maintenance dosing.

The EC requests CHMP to reassess new safety data that emerged after the positive opinion recommending the approval of ...

Japan’s Eisai and US partner Biogen have announced today update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab (trade name Leqembi) as a treatment for early ...

BioArctic’s partner Eisai announces update on regulatory review of lecanemab to treat early Alzheimer’s disease in EU: Stockholm Monday, February 3, 2025, 13:00 Hrs [IST] BioA ...

An effort two decades in the making, Vertex Pharmaceuticals Inc.’s suzetrigine gained U.S. FDA approval as the first drug targeting the NaV1.8 pain signal. Branded Journavx, the oral small molecule is ...

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 ...

Viehbacher, “Biogen”) announced today an update on the ongoing regulatory review of the Marketing Authorization Application for lecanemab as treatment for early AD (mild cognitive impairment due to ...