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 ...
FiercePharma5h
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 ...
BioSpace7m
Kezar’s Autoimmune Drug Hit With Second FDA Clinical Hold in as Many Months
Kezar Life Sciences can’t catch a break this fall with its autoimmune candidate zetomipzomib. Just over a month after the FDA ...
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 ...
MassDevice25m
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 ...
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 ...
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 ...
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.
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 ...
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 ...