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FDA, Leqembi and Alzheimer's

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.

Managed Healthcare Executive · 3h

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.

Yahoo · 14h

FDA clears monthly dosing of Alzheimer’s drug Leqembi

The approval is the first to come from the FDA since the Trump administration paused external communication by health agencies last week.

Zacks.com on MSN · 12h

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.

FDA sets 2nd-highest risk level, product sold nationwide

AL.com on MSN · 13h

First Aid Beauty has recalled nearly 2,800 jars of 14 oz. Ultra Repair Cream Coconut Vanilla moisturizer. According to the company, the products were “inadvertently sold,” and were “not intended for market sale.” The recall covers only Ultra Repair Cream Coconut Vanilla sold directly via FirstAidBeauty.com in the U.S.

First for Women on MSN · 7h

FDA Issues Class II Recall on a Popular Moisturizer

WAFB · 1d

Nearly 2,800 containers of a popular face moisturizer have been recalled. In a recall notice issued by the Food and Drug Administration, First Aid Beauty’s Ultra Repair Cream in Coconut Vanilla was recalled due to a “Current Good Manufacturing Practice deviation.

FDA bans red dye

CNET · 12h

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 artificial red dye found in food and drinks that's been linked to cancer. The decision comes 30 years after scientists first discovered links between the dye and thyroid cancer in animals.

Rolling Out · 10h

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 their potential health risks.

News9 · 13h

FDA's red dye No. 3 Ban sparks health concerns and action

The FDA's ban on Red Dye Number 3, set to take effect in January 2027, raises health concerns among local doctors who recommend reducing artificial food dyes to improve children's health and behavior.

Breast Cancer, FDA and AstraZeneca

Targeted Oncology · 2h

FDA Approves T-DXd in HR+, HER2-Low/Ultralow Breast Cancer

The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer, based on phase 3 DESTINY-Breast06 trial results.

Business Insider · 1h

FDA Approves AstraZeneca And Daiichi Sankyo's ENHERTU For HER2-Low/Ultralow Breast Cancer

The U.S. Food and Drug Administration has approved AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU

MarketWatch · 3h

AstraZeneca Receives FDA Approval for Enhertu Breast Cancer Treatment

AstraZeneca received Food and Drug Administration approval for enhertu, its breast cancer treatment developed in partnership with Japanese company Daiichi Sankyo. The Anglo-Swedish pharmaceutical company said Monday that the treatment's approval was based on results from a Phase III trial,

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 ...

Truthout5h

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 ...

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.

15h

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 ...

STAT12h

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.

medtechdive4h

FDA webpages on clinical trial diversity removed after Trump orders

The website changes raise concerns about “the interference of politics with the study and the practice” of science and ...

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FDA, Leqembi and Alzheimer's

FDA sets 2nd-highest risk level, product sold nationwide

FDA bans red dye

Breast Cancer, FDA and AstraZeneca

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