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, ...
MedPage Today1d
FDA Rejects Full Approval of Liver Disease Drug
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Yahoo News23h
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 ...
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 ...
FierceBiotech4h
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 ...
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Intelligent Bio Solutions Announces Positive Results of PK Study, a Key Milestone on Path to FDA 510(k) Submission
PK Study Successfully Demonstrates that Fingerprint Sweat Provides Reliable Sample for Drug Detection. FDA 510(k) Clearance ...
FiercePharma19h
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 ...
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 ...
Business Insider12h
Positive FDA Feedback and Strategic Advancements Boost Wave Life Sciences’ Investment Potential in Huntington’s Disease
Salim Syed’s rating is based on the positive regulatory feedback from the FDA regarding Wave Life Sciences’ lead candidate, WVE-003, for Huntington’s disease. The FDA’s openness to a pathway for ...