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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...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 (Dec. 27)
The U.S. Food and Drug Administration said on Friday that it has approved an injectable version of Bristol Myers Squibb's ...
STAT1d
Leaving FDA, Califf is unapologetic — and warns of staff departures
In an interview, outgoing FDA commissioner Robert Califf was wary of the Trump administration but unapologetic about ...
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 ...
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 ...
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 ...
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.
Crain's New York15h
Mount Sinai and Memorial Sloan Kettering advance AI tool for new cancer treatment
Researchers at Mount Sinai and Memorial Sloan Kettering believe they’ve made a breakthrough in a new form of cancer treatment ...
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 ...
Deccan Chronicle4d
How healthy is your cuppa?
Tea is officially a health drink now. But does that seal apply to India’s ubiquitous chai too?
Johnson & Johnson: Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis
Biologics License Application acceptance supported by results from the Phase 3 Vivacity-MG3 study Results demonstrate sustained disease control over 24 weeks in a broad ...
Newsom aims to limit unhealthy food in California, getting ahead of Trump administration and RFK Jr.
California Gov. Gavin Newsom ordered state agencies to recommend ways to reduce health harms and limit the purchase of candy, ...