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.
MedPage Today1d
FDA Rejects Full Approval of Liver Disease Drug
Share on Facebook. Opens in a new tab or window Share on X. Opens in a new tab or window Share on LinkedIn. Opens in a new ...
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, ...
Nearly 80,000 pounds of Costco butter recalled for missing 'Contains Milk statement': FDA
Nearly 80,000 pounds of Costco butter was recalled because its packaging was missing the "Contains Milk statement." ...
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 ...
Check your cinnamon before baking a pie. FDA recalls cinnamon in CT due to high lead levels
Before you add some cinnamon to your holiday baked goods, you should check to see if your cinnamon has been recalled. The ...
FiercePharma9h
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 ...
FierceBiotech6h
Adaptimmune gears up for another FDA submission after hitting goal in pivotal sarcoma study
Adaptimmune Therapeutics is prepping for another FDA submission after 42% of patients with sarcoma responded to the company's ...
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 ...
FierceBiotech11h
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 ...
FiercePharma1d
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 ...