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.
US FDA declines full approval for Intercept's liver disease drug
The U.S. Food and Drug Administration on Tuesday declined full approval for Intercept Pharmaceuticals' liver disease drug, ...
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FDA Rejects Full Approval of Liver Disease Drug
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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 ...
US FDA lifts clinical hold on Novavax's combo COVID-flu shot
The U.S. Food and Drug Administration has lifted its clinical hold on a late-stage trial of Novavax's COVID-influenza and its ...
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FDA Commissioner Califf Candid on Trump's Impact: 'We Just Don't Know What's Going to Happen'
FDA commissioner Robert Califf’s second term is anticipated to end in 2025, and all eyes are now on who will be the next to ...
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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 ...
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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 ...
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 ...
These Cold & Flu Medicines Contain an Ingredient the FDA Plans to Ban
The FDA proposed a ban on phenylephrine, a common decongestant found in cold and cough medications. Here’s why and a list of ...
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FDA approves software to turn Appke Airpods into hearing aids
The Food and Drug Administration (FDA) recently gave Apple the green light to use software that may help million of people ...