STAT2d
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After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
STAT16h
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 ...
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 ...
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.
CNN22d
FDA places its most serious warning on menopause drug due to risk of liver injury
The US Food and Drug Administration has placed its most serious warning – a so-called black-box warning – on a drug used to relieve menopausal hot flashes. The FDA says women who are taking ...
The Hill20d
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 ...
Reuters24d
US FDA declines to approve injection form of J&J's lung cancer drug
Dec 16 (Reuters) - The U.S. Food and Drug Administration has declined to approve ... who have mutated form of a gene called epidermal growth factor receptor (EGFR), which causes rapid tumor ...