News

New blood test for Alzheimer's approved by FDA
The U.S. Food and Drug Administration on Friday approved a new blood test for the early detection of Alzheimer's disease in ...
New Alzheimer's test approved by FDA—What to know
This new test is the first blood test ever approved for diagnostics of the disease, according to a press release issued ...
FDA to issue new vaccine approval guidance amid questions over coronavirus shots
FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.” ...
FDA moves to remove children’s products from shelves; says it never gave approval
The U.S. Food and Drug Administration will remove pediatric ingestible fluoride products from the market. The agency cites ...
Never approved children’s fluoride recalled by FDA but dentists push back
An ingestible fluoride prescription drug product for children was pulled from the market on Tuesday after the Food and Drug ...
EatingWell on MSN6d
These 3 Food Dyes Were Just Approved by the FDA—Here's What a Dietitian Thinks
The FDA just announced an approval on three nonsynthetic food dyes. This follows a pending ban on seven different food dyes, ...
FDA and RFK Jr. aim to remove ingestible fluoride products used to protect kids’ teeth
WASHINGTON (AP) — U.S. health regulators announced plans Tuesday to phase out fluoride-containing supplements sometimes used ...
CNET on MSN6d
Say Goodbye to Red Dye No. 3 and Hello to FDA-Approved Natural Food Dyes
Red dye No. 3 is now banned in the US -- but it'll take time to phase it out completely. In the meantime, the FDA just ...
Food Dive2h
FDA to revisit approval of food chemicals that ‘concern consumers most’
The agency is planning a new review process that could result in ingredient bans or additional labeling requirements, ...
BioSpace14h
Makary’s ‘Conditional Approval’ Pathway for Rare Diseases Poses More Questions Than Answers
While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner ...
The FDA Is Replacing Synthetic Food Dyes, and These 3 Just Got the Green Light
The FDA approved three new natural food color additives — galdieria extract, butterfly pea flower extract, and calcium ...
FDA Grants Interchangeable Designation to Fresenius Kabi’s biosimilar Otulfi® (ustekinumab-aauz)
Fresenius Kabi, an operating company of Fresenius, and Formycon AG, announced today that the U.S. Food and Drug Administration (FDA) designated Otulfi® (ustekinumab-aauz) as an interchangeable ...