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 ...
MassDevice18m
FDA clears outpatient cardiac telemetry for SmartCardia ECG patch
SmartCardia announced today that it received FDA clearance for mobile outpatient cardiac telemetry (OCT/MCT) for its ECG ...
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 ...
STAT22h
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 ...
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 ...
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 ...
FierceBiotech6h
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 ...
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.
FiercePharma21h
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 ...
FDA adds new warning to weight loss drugs
The FDA has added a new warning to drugs including Ozempic and Wegovy, cautioning that patients taking the drugs may be at a ...
Yahoo News1d
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 ...
FierceBiotech7h
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 ...