US FDA OKs monthly maintenance dosing for Eisai/Biogen's Alzheimer's drug
The U.S. Food and Drug Administration has approved monthly maintenance dosing for Japan's Eisai and partner Biogen's Alzheimer's drug Leqembi, the companies said on Monday.
FDA Approves New IV Maintenance Dose of Leqembi
A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research shows.
Biogen, Eisai Get FDA Nod for Leqembi IV Maintenance Dosing
Biogen and Eisai have won Food and Drug Administration approval of an intravenous maintenance dosing of their Leqembi drug for early Alzheimer's disease. The companies late Sunday said the FDA approved the maintenance dosing of once every four weeks after 18 months of the initiation phase of once every two weeks.
FDA Approves Once-Every-Four-Weeks Maintenance Dosing Of LEQEMBI For Early Alzheimer's Disease
Eisai Co., Ltd. (ESALF.PK) and Biogen Inc. (BIIB) announced Sunday that the U.S. Food and Drug Administration has approved the
BIIB Secures FDA Nod for Monthly Maintenance Dosing of Alzheimer's Drug
Biogen BIIB announced that the FDA has approved a monthly maintenance dosing version for its intravenously (IV) administered Alzheimer's disease (AD) drug, Leqembi. Post the FDA approval, patients have the option to transition to a monthly maintenance dosing regimen of Leqembi after completing an 18-month course of biweekly infusions of the drug.
Popular face moisturizer recalled: FDA sets second-highest risk level, product sold nationwide
First Aid Beauty has recalled nearly 2,800 jars of 14 oz. Ultra Repair Cream Coconut Vanilla moisturizer. According to the ...
Truthout6h
Trump Aims to Overhaul the FDA. What Does That Mean for Public Health?
Meanwhile, in an executive order, Trump created his long-discussed “Department of Government Efficiency,” to be led by Elon ...
Nearly 20,000 organic milk cartons recalled, FDA says
The FDA said the 8-ounce cartons of whole organic milk were produced by Horizon Organic Dairy, LLC and distributed in Arizona ...
CNET13h
FDA Finally Bans Red Dye No. 3: What You Need to Know
The US Food and Drug Administration announced this month that it's effectively banning Red No. 3, the controversial ...
Rolling Out11h
FDA bans red dye but 8 risky food colors remain legal
Discover what FDA's red dye ban means for your food safety. Learn which synthetic colors remain in your favorite foods and ...
Bird Flu Concerns Prompt New FDA Guidance on Raw Pet Food Safety
MONDAY, Jan. 27, 2025 (HealthDay News) -- Reports of cats becoming seriously ill or dying after consuming raw pet food or ...
No, the FDA is not banning Cosmic Brownies
Even though the FDA is banning red dye No. 3, that doesn’t mean Cosmic Brownies are also taboo. The chocolate treat isn’t ...
Costco salmon recalled for listeria risk elevated to highest risk level, FDA says
In its initial Oct. 22 letter to Costco members, Acme Smoked Fish Corp. said it was issuing the recall “with an abundance of caution” due to potential contamination with Listeria monocytogenes.
FDA-approved nasal spray for severe depression can lead to remission
The Food and Drug Administration (FDA) recently approved the nasal spray Spravato for the treatment of major depression in ...
The FDA pulls key DEI initiative for cancer studies from its website
A Food and Drug Administration project to promote diversity in clinical studies of cancer treatments was removed from the ...
STAT13h
U.S. health agencies see some chaos — but an FDA approval gets through
Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.