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 ...
FDA Commissioner Califf Candid on Trump's Impact: 'We Just Don't Know What's Going to Happen'
FDA Chief Robert Califf reflects on potential changes as Trump's re-election looms, expressing disappointment and ...
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Hims & Hers launches GLP-1 shortage tracker in its battle with the FDA
Hims & Hers (HIMS) is launching a new GLP-1 tracker in its efforts to fight back against the FDA’s decision to end compounded ...
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 ...
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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 ...
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FDA hits Kezar's zetomipzomib program with 2nd clinical hold in 2 months
The agency has placed a partial hold on the phase 2a PORTOLA trial evaluating the selective immunoproteasome inhibitor ...
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 ...
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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GE HealthCare wins FDA nod for new head-only MRI system
GE HealthCare (Nasdaq:GEHC) announced today that it received FDA 510(k) clearance for its Signa Magnus MRI scanner.
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FDA rejects Intercept's ask for Ocaliva full nod in rare liver disease, but accelerated approval remains
In the wake of an unfavorable advisory committee meeting in September, Intercept Pharmaceuticals’ bid to win full approval ...
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Nearly 80,000 pounds of Costco butter recalled for missing 'Contains Milk statement': FDA
Costco customers with dairy allergies may need to check their fridge because 80,000 pounds of the retailer's butter was ...
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Caris scores FDA approval for multi-cancer companion diagnostic test
Caris Life Sciences has obtained an FDA approval for its MI Cancer Seek tumor profiling assay, unlocking its use as a ...