STAT3d
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...
STAT8d
Save the Food and Drug Administration by breaking it up
Snake oil, it turns out, motivated the founding of the FDA. The term “snake oil” arose out of a controversy from the late ...
JD Supra1d
FDA’s Fresh Take on Use of “Healthy” in Food Labeling
On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition ...
FDA's Food Safety Inspections Struggle Amid Staffing Shortfall
The FDA has failed to meet its mandated targets for domestic and foreign food safety inspections since fiscal 2018, the US ...
Solid Biosciences Gains FDA Clearance for New Drug Application
Solid Biosciences received clearance from the Food and Drug Administration for an investigational new drug application, the company said Tuesday.
The Hill21d
FDA updates definition of ‘healthy’ on food labels for first time in 30 years
A new rule from the Food and Drug Administration (FDA) will update what it means for food to be labeled “healthy” for the first time in 30 years, a move that aligns with current nutrition ...
The Hill19d
FDA approves weight-loss drug to treat sleep apnea
The Food and Drug Administration (FDA) approved a weight-loss drug to help sleep apnea, becoming the first drug to treat the disorder affecting millions of Americans. On Friday, the federal agency ...
Why Alzheimer’s Scientists Are Re-thinking the Amyloid Hypothesis
For decades, scientists have been trying to develop therapeutics for people living with Alzheimer’s disease, a progressive ...
Medscape17d
Obesity Drug Zepbound Approved for Obstructive Sleep Apnea
The US Food and Drug Administration (FDA ... OSA treatment has focused on mechanical support during sleep in the form of positive airway pressure (PAP) therapy. "Today's approval marks the ...
Yahoo Finance14d
FDA approves injectable version of Bristol Myers Squibb's cancer drug Opdivo
(Reuters) -The U.S. Food and Drug Administration said on Friday that ... The new injectable form is expected to be more convenient for patients and could help shield the company from erosion ...