STAT6h
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 (Dec. 27)
By Sneha S K and Sriparna Roy (Reuters) -The U.S. Food and Drug Administration said on Friday that it has approved an ...
AccurKardia’s AK+ Guard gains FDA breakthrough device status
AccurKardia has gained the US Food and Drug Administration's (FDA) breakthrough device designation for its AI-powered ‘AK+ ...
STAT6d
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 ...
Biden FDA moves forward with rule to lower nicotine in cigarettes, a ‘gift’ to cartels, critic says
Opponents argue that the change could cause current smokers to use more cigarettes to compensate for the lower nicotine ...
Afro1h
FDA updates the definition of ‘healthy’ foods
New FDA rules for 'healthy' food labels aim to align with federal dietary guidelines. Changes include limits on added sugars and sodium, and prioritize whole foods.
Johnson & Johnson Gets FDA Fast-Track Designation for Posdinemab in Alzheimer's
The New Brunswick, N.J., pharmaceutical giant said posdinemab has shown potential in targeting disease-associated phosphorylated tau in cerebrospinal fluid from treated Alzheimer's patients, and in ...
FDA Limits Toxic Lead in Some Baby Foods
The agency issued final guidance that it estimated could reduce lead exposure from processed baby foods by about 20% to 30%.
aha.org18h
FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
JD Supra1d
FDA Issues Draft Guidance on Accelerated Approval Focused on How the Agency Will Implement New Authorities
On December 5, 2024, the U.S. Food and Drug Administration (FDA or Agency) issued a draft guidance entitled Expedited Program for ...
White House readies nicotine proposal in administration’s final days
Click in for more news from The Hill{beacon} Health Care Health Care   The Big Story FDA rule to lower nicotine levels closes ...
COUR Pharmaceuticals Secures FDA Orphan Drug Designation for CNP-104 in Primary Biliary Cholangitis
COUR Pharmaceuticals, a clinical-stage biotechnology company developing first-in-class, disease-modifying therapies designed ...