Travere Therapeutics to Submit sNDA for FILSPARI® (sparsentan) in FSGS
Company completed Type C meeting with FDA, aligning on its plan to submit an sNDA; submission expected around end of 1Q25If approved, FILSPARI ...
Hims & Hers Super Bowl controversy: What the ad left out about its 'alternative' weight-loss drugs
The telehealth company Hims & Hers put out a Super Bowl ad that skimped on clarifying that its compounded semaglutide medications aren't FDA-approved.
Cure Today16h
Breaking Down the FDA Labeling Update of Xeloda and 5-FU in Cancer Care
The FDA has updated the product labeling for Xeloda and 5-FU to highlight the risks associated with dihydropyrimidine ...
Cure Today19h
An Expert Breaks Down What DPD Is and Labeling Updates From The FDA
Dr. Gabriel A. Brooks discusses the recent FDA product labeling update for Xeloda and 5-FU which aims to highlight risks associated with DPD deficiency.
The National Law Review20h
Proposed FDA Rule May Require Stricter Testing for Talc in Cosmetic Products
Recent federal developments may soon require cosmetic companies to adopt stringent precautions to ensure that talc-containing ...
FDA food label proposal could help Americans' health, UVA dietician says
The front-of-package labels could help consumers identify how ingredients in foods can be a part of a healthy diet.
Food Safety News3d
FDA steps up import enforcement because of pesticides, undeclared colors, and more
The Food and Drug Administration uses import alerts to enforce U.S. food safety regulations for food from foreign countries. The agency updates and ...
JD Supra3d
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Food Allergy Research & Education3d
Update to FDA Guidance for Food Allergen Labeling
Changes to the FDA labeling guidance in support of FALCPA include alterations to the definitions of “major” food allergens ...
Science Daily3d
Nutrition labels meant to promote healthy eating could discourage purchases
As the U.S. Food and Drug Administration weighs whether to require front-of-package food labels, a new study shows some food labels designed to nudge Americans toward healthier food choices can have ...
STAT4d
FDA clinical trial inclusivity guidelines will be back
Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...
Updated drug information handout outdoes FDA's version in clinical trial
A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an ...