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FDA Rejects NK1R Antagonist for Gastroparesis
Support for the neurokinin-1 receptor (NK1R) antagonist included a negative phase III trial and a positive phase II study ...
US FDA approves Elanco's skin disease treatment for dogs
The U.S. Food and Drug Administration has approved Elanco Animal Health's skin disease treatment for dogs, the health ...
Waffle Recall Update As FDA Sets Risk Level for 13 States
The products were voluntarily recalled "due to the potential presence of soft plastic film," leading them to be given a Class ...
FDA finds some 'dairy-free' chocolate products contain milk
Consumers should be aware that some chocolate labeled as "dairy-free" actually contains milk, the U.S. Food and Drug ...
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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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FDA designates devices for heart surgery, smart knee implant as ‘breakthroughs’
The program gives manufacturers better access to regulators and the ability to design more flexible clinical trials.
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Granules India scolded over truckloads of torn manufacturing documents after recent FDA inspection
From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing ...
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 ...
FDA to investigate metals found in tampons after study; study's co-author 'excited' over probe
The FDA will now investigate metals found in tampons following the results of a recent study. The study's co-author weighs in ...
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Treatment for allergic skin conditions receives FDA approval
The FDA announced earlier today that ilunocitinib tablets (Zenrelia; Elanco) has received its approval. The latest drug from ...
FDA expands use of Kisqali to early stage breast cancer patients
Women with early stage breast cancer may now take Kisqali, a medication already approved for advanced disease.
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 ...