Reuters5h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
This allows them to produce the missing AADC enzyme that can help produce dopamine and treat the condition. PTC Therapeutics ...
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." ...
MedPage Today2d
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 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 ...
The Baltimore Sun3h
FDA announces common over-the-counter cough and cold medicine doesn’t work
The FDA’s proposal comes more than a year after its outside advisers voted against the continued use of oral phenylephrine, ...
FDA Recalls 80,000 Pounds of Costco Butter Over Missing Milk Allergy Warning
Last month, the U.S. Food and Drug Administration (FDA) recalled almost 80,000 pounds of Costco's popular store-brand butter ...
FDA Recalls Costco Butter for a ‘Peculiar’ Reason—Here’s What to Know
Save the addition of salt, spices and other add-ins for taste, butter is a single-ingredient food. So, it may come as a ...
STAT5h
FDA is still struggling with a lack of inspectors, but doesn’t have a plan, watchdog finds
A key reason positions haven't been filled is that they require travel that ranges from 25% to 75% of the time.
FiercePharma16h
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 ...
News Medical5h
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs ...
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 ...