US FDA declines full approval for Intercept's liver disease drug
By Bhanvi Satija and Puyaan Singh (Reuters) - The U.S. Food and Drug Administration on Tuesday declined full approval for ...
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FDA bans certain synthetic dye from cosmetics but allows in food, advocate calls it ‘illogical’
BIRMINGHAM, Ala. (WBRC) - The U.S. Food and Drug Administration (FDA) does not allow Red No. 3 to be used in cosmetics, but ...
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After election, FDA's Califf lays out hopes for his Trump-appointed successor
While personally “disappointed” about the election’s outcome, current FDA Commissioner Robert Califf, M.D., has laid out the ...
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FDA Denies Full Approval of Obeticholic Acid for Primary Biliary Cholangitis
The sNDA was submitted to support full approval of OCA for this indication based on data from the COBALT trial, as well as real-world evidence.
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Inaugural Meeting for FDA's Digital Health Advisory Committee to Focus on GenAI-enabled Medical Devices
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...
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FDA Chief Robert Califf reflects on potential changes as Trump's re-election looms, expressing disappointment and ...
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FDA commissioner suggests RFK Jr. and Trump might compromise an agency ‘at peak performance’
The agency’s ability to hire and retain skilled employees may be in jeopardy given Trump ally Robert F. Kennedy Jr.’s ...
Kennedy’s FDA wish list: Raw milk, stem cells, heavy metals
Robert F. Kennedy Jr., one of President-elect Donald Trump’s advisers on health, is taking aim at the agency’s oversight on ...
The FDA is urging these brands of ground cinnamon products to issue voluntary recalls
The products are part of the agency's ongoing public health alert concerning cinnamon with elevated lead levels ...
FDA Recalls Chronic Kidney Disease Medication Over Impurity Concerns
Nearly 300,000 bottles of the drug, named Cinacalcet, were recalled and given a Class II recall risk level by the FDA.
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FDA clears outpatient cardiac telemetry for SmartCardia ECG patch
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FDA Rejects Full Approval of Liver Disease Drug
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