News

Lomecel-B granted FDA RMAT status for mild Alzheimer’s

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Longeveron’s experimental cell therapy Lomecel-B for mild Alzheimer’s disease. The designation is designed to accelerate the development and review processes for regenerative medicine candidates, including cell therapies, intended to treat, modify, reverse,…

FDA approves donanemab, now Kisunla, to treat early Alzheimer’s

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly‘s antibody therapy donanemab, now Kisunla, for certain adults with Alzheimer’s disease. Specifically, Kisunla is indicated for patients with early symptomatic Alzheimer’s — to include individuals with mild cognitive impairment or mild dementia, and confirmed evidence of…