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U.S. FDA declines to approve Vanda's stomach paralysis drug
The U.S. Food and Drug Administration has declined to approve Vanda Pharmaceuticals' drug to treat stomach paralysis symptoms, the company said on Thursday. Shares of the company fell about 14% to $4.
FDA rejects Vanda Pharmaceuticals' application to bring key drug to market
A D.C. drugmaker has been dealt a major setback in its long-running bid to bring its treatment for a chronic gastrointestinal disease to market.
FDA Rejects Vanda Pharma's Application for Gastroparesis Drug Tradipitant
The Food and Drug Administration has turned away a proposed drug from Vanda Pharmaceuticals to treat the stomach disorder gastroparesis. Vanda on Thursday said the FDA has issued a so-called complete response letter for the drug,
US FDA declines to approve Vanda's stomach condition drug
Vanda Pharmaceuticals said on Thursday the U.S. Food and Drug Administration declined to approve its drug to treat a type of stomach condition that disrupts digestion and called for additional studies.
Vanda slips as FDA rejects therapy for stomach condition
Vanda Pharmaceuticals (NASDAQ:VNDA) fell ~9% in the premarket on Thursday after the U.S. FDA declined to approve its marketing application for experimental therapy, tradipitant for a stomach-related medical condition called gastroparesis.
2d
The FDA wants to place warning labels on food packages to combat obesity and other health conditions
The Food and Drug Administration (FDA) is looking to propose the inclusion of front-of-package warning labels that detail the ...
2d
FDA to propose new food label warnings to combat obesity
The FDA is considering food labels to help consumers identify products with unhealthy ingredients, but some experts wonder if ...
STAT
12h
FDA cites Granules, a large Indian generic drug manufacturer, for tossing truckloads of key documents
FDA cites Granules, a large Indian generic drug manufacturer, for tossing truckloads of important documents from a facility ...
31m
Neu-REFIX Beta glucan receives rare pediatric disease and orphan drug designations from the US FDA for treatment of Duchenne Muscular Dystrophy
Neu refix granted orphan disease designation (ODD) & rare pediatric disease designation (RPDD) by US FDA for treatment of ...
Food Safety News
4d
FDA warns food companies for violations in acidified foods and seafood imports
The Food and Drug Administration sends warning letters to entities under its jurisdiction as part of its enforcement ...
5d
on MSN
Following massive recalls and outbreaks, Americans are losing confidence in food safety regulations
A Gallup poll has found that consumers' confidence in food safety has dropped by 23 points between 2006 to 2024 ...
Scientific American
14h
Obesity-Drug Pioneers Win Prestigious Lasker Award for Medical Science
Three scientists are honored for developing a class of blockbuster weight-loss drugs. Is a Nobel prize on the way?
USA Today
4d
New eczema drug from Eli Lilly receives FDA approval for children and adults
On Friday, the U.S.
Food
and Drug
Administration
approved Eli Lilly's eczema
drug
for use in adults and children 12 ...
JD Supra
4d
Recap of the FDA and CTTI Public Workshop on AI in Drug Development
On August 6, 2024, the
Food
and Drug
Administration
(FDA) partnered with the Clinical Trials Transformation Initiative ...
Asia One
5d
Breakthrough Therapy designation for Sanbexin sublingual tablets granted by the United States Food and Drug Administration
On September 2, 2024, Simcere Pharmaceuticals Group Ltd. (2096.HK) announced that Sanbexin Sublingual Tablets (Edaravone and ...
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