Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like ...
The U.S. Food and Drug Administration has labeled the broccoli recall as a Class I, the highest risk level issued by the ...
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic ...
Changes to the FDA labeling guidance in support of FALCPA include alterations to the definitions of “major” food allergens ...
In the face of tough competition from Apellis and a recent setback with prescribers, Astellas’ geographic atrophy (GA) med ...
"La Fiesta Bread Crumbs face an FDA Class I recall for undeclared sesame, highlighting the need for accurate allergen ...
On January 14, 2025, the Food and Drug Administration (FDA) proposed a new requirement for all packaged foods to have a front ...
The FDA has updated the product labeling for Xeloda and 5-FU to highlight the risks associated with dihydropyrimidine ...
Indivior PLC (Nasdaq/LSE: INDV) provides the following update regarding its PDUFA action date for label changes (rapid initiation protocol and alternative injection sites) for SUBLOCADE® ...
Librela (bedinvetmab injection) is a monthly injectable monoclonal antibody, for which real-world drug experience data has ...
WASHINGTON, D.C. – The U.S. Food and Drug Administration has updated a recent vegetable recall to its most serious category.
The update comes about six weeks after an early alert flagged reports of 120 injuries and one death linked to reprocessing of ...
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