First appropriate use guidance published for Alzheimer’s drug Aduhelm
By
Alicia Lasek
Jul 28, 2021
The new guidelines cover how to choose appropriate patients, safely scale up to a full dose, monitor side effects and assess effectiveness. The authors also address when to stop therapy and what patients...
U.S. lawmakers ramp up scrutiny of FDA following agency’s approval of controversial Alzheimer’s drug
By
Alicia Lasek
Sep 07, 2021
The FDA is being asked to help explain how Aduhelm (aducanumab) met accelerated approval criteria when so many experts — including internal advisers — have flagged insufficient safety and efficacy...
House committees to investigate new Alzheimer’s disease drug approval
Jul 01, 2021
FDA approved Aduhelm earlier this month, despite advisory committee’s conclusion that there was not enough evidence to support its effectiveness
Trial begins of nasal vaccine for Alzheimer disease
Nov 18, 2021
Phase 1 trial will include 16 patients ages 60 to 85 years who have early, symptomatic Alzheimer disease but are otherwise in good health
Eli Lilly aims for dementia drug candidate’s approval in 2022; wants to ‘prioritize access’
By
Alicia Lasek
Aug 04, 2021
The Alzheimer’s disease-modifying drug donanemab is on track to be considered for full FDA approval by 2022, its developer said.