News

The U.S. Food and Drug Administration (FDA) has approved the oral therapy Zunveyl (benzgalantamine), previously known as ALPHA-1062, to treat mild-to-moderate Alzheimer’s disease. “The approval of Zunveyl is a pivotal moment in the fight against Alzheimer’s disease as it is only the second oral [Alzheimer’s] treatment…

The use of Montelukast oral film, an experimental therapy being repurposed by Intelgenx to treat mild to moderate Alzheimer’s disease, led to significant improvements in patients’ cognition versus a placebo in a Phase 2 clinical trial. That’s according to the findings of a top-line analysis of efficacy data…

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,…

Foralumab, an investigational nasal spray being developed by Tiziana Life Sciences, has been cleared by the U.S. Food and Drug Administration (FDA) for expanded use to treat moderate Alzheimer’s disease, and the first patient is expected to be dosed soon. An expanded use program, also called a compassionate…

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…

The safety and effectiveness of oral therapy candidate buntanetap are comparable in people with early Alzheimer’s disease regardless of whether they do or do not carry a genetic risk factor known as APOE4. That’s according to new data from a Phase 2/3 clinical trial (NCT05686044) that tested…

Note: This story was updated June 21, 2024, to correct that SNK01 was given approval by NKGen Biotech’s Safety Review Committee. SNK01, a natural killer (NK) cell therapy being developed by NKGen Biotech, has received clearance from its Safety Review Committee to advance into the Phase 2 part of a…

The U.S. Food and Drug Administration (FDA) has agreed to review a supplemental application seeking authorization of once-monthly maintenance dosing for Leqembi (lecanemab), an approved treatment for early Alzheimer’s disease. A decision from the agency is expected by Jan. 25, 2025, according to a press release from…

An advisory committee to the U.S. Food and Drug Administration (FDA) has unanimously voted in favor of donanemab, an anti-amyloid therapy developed by Eli Lilly that’s currently up for approval as a treatment for early Alzheimer’s disease. All members of the FDA’s Peripheral and Central…

There’s lots of ways to support Alzheimer’s and Brain Awareness Month this month, from “going purple” to sharing facts and resources, to help call attention to the estimated 47 million people globally who live with Alzheimer’s disease or dementia. Alzheimer’s is the most common cause of…