Drug approvals news
What's happening in Alzheimer's care, research funding, and treatment — summarized simply, each item linked to the original reporting.
Free to read, “May need a subscription” and “Archived copy”: what they mean
Whether an article is free to read is a guess, not a test of your access. Each item is one of three:
- No label: free to read (303 of 347). The publisher’s page marks it free, or the outlet publishes free to read: Medical Xpress, ScienceDaily, NIH (incl. NIA and PMC), Alzheimer's Association, Alzheimer's News Today, NPR, Alzheimer's Disease International, or a .gov site.
- May need a subscription (11 of 347). The publisher’s own page marks the article as not free to read, or — when the page says nothing — the outlet sells subscriptions: The New York Times, STAT, Scientific American, The Washington Post, The Wall Street Journal, Financial Times, The Economist, Bloomberg, The Atlantic, The New Yorker, Wired, Los Angeles Times, The Boston Globe, The Times, The Telegraph, New Scientist, Endpoints News, Science. Each badge says which.
- “Free to read? Not known” (33 of 347). The outlet is on neither list and its page said nothing. We do not call these paywalled.
Archived copy links go to a copy the Internet Archive (web.archive.org) saved, dated the day it was saved. We show one only where the Internet Archive reported a working saved copy when we checked; an archived copy of a subscription article sometimes shows only its opening. 265 of 347 items have one.
FDA approves Auvelity to treat Alzheimer’s-related agitation
The U.S. Food and Drug Administration (FDA) has approved a new first-in-class treatment, Auvelity (dextromethorphan-bupropion), for the treatment of agitation associated with Alzheimer’s disease. …
Read at Alzheimer's News Today →FDA fast-tracks expanded home injections for Alzheimer’s drug Leqembi
The U.S. Food and Drug Administration (FDA) is reviewing an application seeking expanded approval of an under-the-skin injection version of Leqembi (lecanemab), called Leqembi Iqlik. Leqembi is an approved treatment for early Alzheimer’s disease. …
Read at Alzheimer's News Today →FDA decision on AXS-05 for Alzheimer’s agitation expected April 30
The U.S. Food and Drug Administration (FDA) granted priority review to an application from Axsome Therapeutics seeking approval of its oral therapy AXS-05 to treat agitation related to Alzheimer’s disease, and expects to decide by April 30, the company said. …
Read at Alzheimer's News Today → Archived copy (1 Jul 2026), Internet ArchiveFDA Approves Weekly Subcutaneous Maintenance Dosing for Leqembi (Leqembi IQLIK)
The FDA approved a weekly at-home subcutaneous autoinjector maintenance dose of lecanemab (Leqembi IQLIK) for early Alzheimer's disease, the first amyloid-clearing antibody approved for self- or caregiver-administered injection. Patients who complete the initial 18-month IV infusion phase can switch to weekly injections.
Why it matters: Reduces the burden of regular infusion-center visits for patients and caregivers, making long-term treatment more convenient and potentially improving adherence.
Read at Alzheimer's Association → Archived copy (8 Jun 2026), Internet ArchiveFDA to Recommend Additional, Earlier MRI Monitoring for Patients With Alzheimer's Disease Taking Leqembi
After identifying 101 serious ARIA-E cases, including four fatalities occurring after the third infusion, the FDA required an additional MRI scan between the second and third lecanemab infusions, on top of previously scheduled monitoring scans.
Why it matters: A direct safety response meant to catch dangerous brain swelling earlier in patients on Leqembi, potentially preventing serious complications or deaths before they become symptomatic.
Read at FDA → Archived copy (10 Sep 2026), Internet ArchiveFDA Approves Label Update for Kisunla to Reduce ARIA-E Risk
The FDA approved a revised, more gradual titration dosing schedule for donanemab (Kisunla) based on the TRAILBLAZER-ALZ 6 study, which found the new regimen cut ARIA-E brain-swelling side effects by 41% at 24 weeks and 35% at 52 weeks without reducing amyloid-clearing efficacy.
Why it matters: A dosing change that meaningfully lowers a serious, sometimes fatal side-effect risk for patients on donanemab, without sacrificing the drug's benefit.
Free to read? Not known for this outlet.
Read at PharmExec (reporting Eli Lilly/FDA action) → Archived copy (11 Jun 2026), Internet ArchiveEuropean Commission Approves First Disease-Modifying Treatment for Alzheimer's in the EU
The European Commission authorized lecanemab (Leqembi) for early Alzheimer's disease across the EU, restricted to patients with no or one copy of the ApoE4 gene variant, after the EMA initially rejected it in 2024 and reversed course on appeal.
Why it matters: Opens access to the first amyloid-targeting therapy in Europe, though with tighter eligibility than in the U.S. and dependent on each country's reimbursement decisions.
Read at Alzheimer's Disease International → Archived copy (5 Sep 2026), Internet ArchiveFollow new items in a feed reader: Atom feed.