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The FDA Wants To Shrink Nicotine Content in These 5 Products
First recommended by a Trump-appointed FDA leader, multiple administrations have collaborated to snuff out this issue that ...
Trump officials pause health agencies’ communications, citing review
The agencies are charged with making decisions that touch the lives of every American and are the source of crucial ...
STAT9h
Sanofi is warned by the FDA over ‘significant’ problems at a key manufacturing plant
The FDA has warned Sanofi about a series of “significant” manufacturing problems, including contamination, at a key facility ...
FDA proposes mandatory front-of-package nutrition labels to combat spike in chronic diseases
The U.S. Food and Drug Administration (FDA) is demanding increased, in-your-face food transparency when it comes to nutrition ...
STAT19h
Three former FDA officials: Here’s what Trump and his nominees need to know
The FDA is the leading science-based consumer protection agency in the world. Three former senior officials write about what ...
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 ...
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 gets FDA Fast Track for FA gene therapy
CHARLESTOWN, Mass. - Solid Biosciences Inc. (NASDAQ:SLDB), a $130.65 million market cap biotechnology company, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) ...
STAT13h
A next-generation form of chemotherapy wins FDA approval
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The National Law Review12h
FDA Issues New Recommendations on Use of AI for Medical Devices, Drugs, and Biologics
In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued ...
JD Supra16h
Federal Circuit Says Proper Orange Book-Listed Patent Must Claim Active Ingredient
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon ...