JD Supra4h
Finally, FDA’s Final Word on Unapproved Use Communications
On January 7, 2025, the U.S. Food and Drug Administration (“FDA” or “Agency”) released a long-awaited guidance titled, “Communications From Firms ...
Healio7h
Researchers stress need for clear, consistent standards in FDA review of psychiatric drugs
The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...
Drugmaker to study pig kidney transplants in humans with groundbreaking trial
FDA clears United Therapeutics for human trials of pig-to-human kidney transplants. Trial involves gene-edited pig kidneys ...
Crain's Chicago Business8h
AbbVie gets FDA OK on antibiotic therapy that fights resistant bacteria
It's the first and only such therapy approved to fight antimicrobial resistance, or AMR, in bacterial infections.
Filter12h
FDA’s Authorization of Zyn Nicotine Pouches a Step in the Right Direction
The groundbreaking decision is a win for harm reduction, though it also highlights absurd contradictions in the FDA's overall ...