News

FDA issues most serious risk warning for cheese recall
A recall of cheese curds over potential contamination with Listeria monocytogenes has received the highest risk warning from ...
GH Research Responds to FDA Clinical Hold on Depression Treatment GH001 Ahead of Schedule
GH Research (NASDAQ:GHRS) is one of the best-performing NASDAQ stocks according to analysts. On June 20, GH Research ...
PharmExec1h
AI’s Realistic Capabilities in FDA’s Approval Process
One of the goals of the current administration is to implement the use of AI in FDA’s approval process. Proponents of the ...
FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...
FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label ...
Nationwide gummies recall update as FDA issues highest risk warning
Vita Warehouse Corp. recalled more than 40,000 bottles of Vitamin B12 supplements for possible undeclared presence of peanut.
Fierce Pharma50m
Eli Lilly's Kisunla wins FDA nod for new dosing with fewer side effects in Alzheimer's
The benefit-risk balance is tipping more in favor of Eli Lilly’s Kisunla in early Alzheimer’s disease as the FDA approves a ...
Courthouse News Service7h
Judge revokes FDA injunction allowing abortion pill access
The ruling reverses the judge’s own decision from two years ago that allowed Washington state and 17 other states to continue ...
The Manila Times11m
Purespring Therapeutics announce FDA IND clearance for Phase I/II clinical trial for primary IgA nephropathy (IgAN)
PS-002, Purespring’s lead precision nephrology programme, targets the complement pathway known to be a driver of IgA ...
STAT1d
Inside the staff exodus and tanking morale that threaten Makary’s FDA
The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s work, current ...
RFK Jr.'s FDA officials overrode career staff to limit COVID shots
The FDA's Dr. Vinay Prasad said that he disagreed with the agency's career vaccine reviewers about COVID shot approvals.
STAT18h
Fed-up and demoralized, FDA staff are leaving.
This is the web edition of D.C. Diagnosis, STAT's twice-weekly newsletter about the politics and policy of health and ...