News

US FDA to roll back lab-developed test oversight rule following court decision

The U.S. Food and Drug Administration will rescind a rule that tightened regulations for clinical laboratories and gave the ...
American Hospital Association

FDA vacates final rule regulating lab-developed tests as medical devices

The Food and Drug Administration released a final rule Sept. 18 that rescinds one from 2024 that applied medical device rules ...

FDA proposes ban on Orange B, a food dye not used for decades

Federal regulators are proposing to remove another artificial dye from the U.S. food supply — Orange B, a synthetic color ...

US FDA approves Incyte's eczema cream for pediatric patients

The U.S. Food and Drug Administration has approved Incyte's eczema cream for children aged between 2 and 11 years, the ...

Trump Drug Ad Crackdown: FDA Warns Novo Nordisk, Eli Lilly, Hims

Letters from the FDA targeted over 100 companies, saying multiple drug firms are pushing “false or misleading” claims about ...

Orange B food dye may soon be removed from US market, FDA says

Federal health officials want to take Orange B—an artificial food dye that hasn't been used in more than four decades—off the ...

U.S. FDA sends drug advertising warning letters to Lilly, Novo, Hims

The U.S. Food and Drug Administration issued warning letters to Eli Lilly , Novo Nordisk and telehealth firm Hims & Hers ...

FDA takes aim at Hims and other telehealth services in drug advertising blitz

WASHINGTON (AP) — For the first time, federal health officials are taking aim at telehealth companies promoting unofficial ...