FDA spars with Waco company over ‘unapproved’ and ‘unlicensed’ human amniotic products
Federal regulators have warned a Waco company that its human amniotic products are “unlicensed” and “unapproved,” and that its manufacturing process violates safety regulations. The U.S. Food & Drug ...
JD Supra3h
FDA’s New Rule for “Healthy” Claim Has Broad Implications for Food Industry
The U.S. Food and Drug Administration (FDA) recently finalized its long-awaited rule for the use of "healthy" claims on food ...
Lose It! on MSN4h
What Does the FDA’s New Definition of ‘Healthy’ Mean for You?
Finding healthier foods just got easier, thanks to the FDA’s updated guidelines for what qualifies as ‘healthy.’ Learn the ...
Urgent warning over recalled salmon sold at Costco that carries 'reasonable risk of DEATH'
The FDA revealed the recall , and said it was its highest risk level - or a Class I - meaning there is a 'reasonable ...
Can a Nasal Spray Really Help Treat Depression? Here's What to Know About Spravato
Here's what MDs want you to know about Spravato, the latest FDA-approved standalone nasal spray for depression.
What the FDA ban on Red Dye No. 3 means for consumers
For consumers, the ban on Red No. 3 represents a small victory for public health and safety. It shows that the FDA is ...
The FDA is about to make weight-loss drugs a lot harder to get
Lots of people are on cheaper compounded weight-loss drugs that mimic brands like Ozempic, Wegovy, and Zepbound. They're ...
Healio2d
FDA approves Spravato as monotherapy for adults with major depressive disorder
The FDA has approved a supplemental new drug application for Spravato, an esketamine nasal spray that can be used as ...
Solid Biosciences Receives FDA Fast Track Designation for SGT-212 Dual Route of Administration Gene Therapy for Friedreich’s Ataxia
Only dual route gene transfer therapy in development to treat Friedreich’s ataxia with FDA IND clearance and Fast Track designation ...
Solid Biosciences' Ataxia Treatment Receives FDA Fast-Track Designation
Fast-track status will allow Solid Biosciences to have more frequent meetings with the FDA throughout the treatment-development process and, potentially, get the product to patients faster than would ...
FDA approves Johnson & Johnson's nasal spray for depression as standalone treatment
The Food and Drug Administration on Tuesday approved Johnson & Johnson's nasal spray to be used alone in adults with a major depressive disorder.