New federal mandate on breast density: Essential guidance for clinicians and patients
A new federal mandate requires that all women undergoing mammography in the U.S. be informed about their breast density—a ...
JD Supra4h
FDA’s Recent Guidance on Accelerated Approval and Implications for Rare Diseases
In honor of Rare Disease Day on February 28, 2025, we will publish a series of posts throughout the month on As Prescribed ...
Healio4h
American Society of Anesthesiologists shares guidance for safe nonanesthetic ketamine use
The American Society of Anesthesiologists released new guidance on the safe use of ketamine for nonanesthesia purposes, such ...
grocerydive5h
FDA delays crackdown on which foods can be labeled ‘healthy’
The rule would prevent many cereal and yogurt products from making nutrition claims and allow nuts, oils and certain seafood to bear the label for the first time.
FDA recognizes need for immunogenicity assays in therapeutics with carriers or conjugates
A new article in the journal Nucleic Acid Therapeutics addresses the recognition by the U.S. Food and Drug Administration ...
WFYI7h
Indiana joins states calling for the FDA to clamp down on counterfeit weight loss drugs
Over 30 state attorneys general including in Indiana, Kentucky, and Ohio have urged the Federal Food and Drug Administration ...
Examining The FDA's Recommendations For AI-Enabled Medical Devices
The FDA stated that its published medical device cybersecurity requirements from 2023 do include AI in a broad sense. However ...
Avadel Pharmaceuticals Reiterates 2025 Guidance as it Reports Fourth Quarter and Full Year 2024 Financial Results
LUMRYZ™ generated $50.4 million in sales in the fourth quarter, up 158% year-over-year, taking the full-year total to $169.1 million, in line ...
BioSpace17h
FDA, Other Experts Seek to Redefine Obesity and Prioritize Maintenance Treatment
Two recent documents—one from the FDA, the other from a commission organized by The Lancet Diabetes & Endocrinology—indicate ...
gna1d
Use of Red Dye-3 in food is guided by standards — FDA
The Food and Drugs Authority (FDA) has clarified that the Red Dye-3 or erythrosine (E127) can be used in foods ...
BioSpace3d
Transparency Missing in Action at HHS Despite Leaders’ Calls for Clarity
In the five weeks since Donald Trump returned as U.S. president, the FDA, NIH and CDC have been thrown into disarray, with ...