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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.

The Business Journals · 15h

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.

MarketWatch · 16h

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,

Reuters on MSN · 15h

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.

Seeking Alpha on MSN · 16h

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.

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Eli Lilly wants records of people who took copies of its weight-loss drug

“I am gobsmacked that Lilly is seeking confidential patient medical records to build a case against the very therapies that ...

Hosted on MSN6h

Nearly 1,500 Bottles of a Baby Product Recalled in 12 States and Sold on Amazon

The FDA is citing the presence of a government-regulated ingredient due to its possible hazards for children and adults. The ...

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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 ...

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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 ...

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 ...

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ELAN : FDA Oks Zenrelia, Once-Daily Oral JAK Inhibitor For Dogs With Allergic And Atopic Dermatitis

Elanco Animal Health Inc. (ELAN) announced the U.S. Food and Drug Administration has approved Zenrelia, a convenient once-daily oral ...

Food Safety News4d

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 ...

Scientific American10h

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?

The Times Leader2m

Barnesville super provides annual Food Service report

Although tonight is football Friday, Barnesville Exempted Village School District Superintendent Micha Fuchs called an ...

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 ...

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