food and drug administration news

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.

The Business Journals · 4h

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 · 5h

FDA Rejects Vanda Pharma's Application for Gastroparesis Drug Tradipitant

Vanda said it will continue to pursue approval of tradipitant in gastroparesis, a condition that affects the stomach muscles and prevents proper stomach emptying, and that it plans to file a separate application later this year seeking a green light for the drug for the prevention of vomiting in motion sickness.

Reuters · 5h

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.

Seeking Alpha on MSN · 4h

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.

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 ...

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 ...

Food Safety News3d

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 ...

TRUTH in Labeling Act would heighten the warning for shoppers looking to cut sugar, salt and saturated fat intake

If the legislation passes, the new label would be centered on the front of the package. But it’s an add-on, not a replacement ...

10hon MSN

FDA Expands Use of Breast Cancer Drug Kisqali

Women with early-stage breast cancer may now take Kisqali, a medication already approved for advanced disease, following the ...

16m

A drug made by a Florida company has been recalled for a possibly lethal contamination

A New Jersey company recalled one batch of a drug made in Florida and sold nationwide after finding a potentially deadly ...

Sanofi, AstraZeneca win US approval for RSV therapy manufacturing line

Sanofi said on Monday the U.S. Food and Drug Administration has approved a manufacturing line for its and partner AstraZeneca ...

Asia One5d

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 ...

Longboard Pharmaceuticals Receives Rare Pediatric Disease Designation and Orphan Drug Designation for Bexicaserin (LP352) in Dravet Syndrome

Longboard Pharmaceuticals, Inc. (Nasdaq: LBPH), a clinical-stage biopharmaceutical company focused on developing novel, transformative medicines for neurological diseases, today announced that the FDA ...

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