In 2014 neurologist Jeffrey L. Cummings, MD, startled the Alzheimer’s disease research world with a paper that laid bare the alarmingly high failure rate of Alzheimer’s disease therapies in development.

The FDA was busy in September 2023, making a number of decisions on potential new therapeutic agents including granting approvals, updating a label, issuing complete response letters, granting a clearance, and lifting a clinical trial hold, among other actions.

The Miami company is developing treatments for aging-related chronic diseases.

Top-line Phase IIa data has demonstrated an allogeneic stem-cell therapy facilitated a lack of deterioration in cognitive signals in mild Alzheimer’s.

Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, today announced positive top-line results from its Phase 2a trial of its investigational product Lomecel-B™ for the treatment of mild Alzheimer’s disease.

As a neurologist with more than 30 years in the field of Alzheimer’s disease, I have had many heartbreaking conversations with patients and their loved ones. More than 6 million people in America are living with Alzheimer’s disease, and that staggering number is expected to double within the next 30 years unless there is a change. However, I am more optimistic about that change and physicians’ ability to slow the course of this devastating illness than I have ever been in the past.

Approved in 2016, the newly updated label changes add more clarity to the use of pimavanserin, noting that patients with Parkinson disease with dementia may be eligible for treatment.

The US Food & Drug Administration (FDA) has made 2 updates to the packaging label for an approved treatment for Parkinson disease psychosis.