JD Supra5h
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.
AbbVie gets FDA approval for antibiotic treatment Emblaveo (update)
AbbVie (ABBV) said it has received FDA approval for the combination antibiotic treatment Emblaveo, which was co-developed ...
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 ...
Does at-home red light therapy really work? Learn the science from our experts
Our experts explain the science behind red light therapy, and if it really works. Plus, we recommend some FDA-cleared wands ...
STAT1d
FDA clinical trial inclusivity guidelines will be back
Following the president’s recent executive order dismantling diversity, equity, and inclusion policies, the main page for the ...
Targeted Oncology1d
FDA Grants Key Oncology Approvals and Designations in January 2025
On January 7, 2025, the FDA granted priority review to the new drug application for sunvozertinib (DZD9008), an oral EGFR ...
FDA approves Symbravo for acute treatment of migraine in adults
The U.S. Food and Drug Administration has approved Axsome Therapeutics' Symbravo (meloxicam and rizatriptan) for the acute ...
Interesting Engineering on MSN2d
Breakthrough: US FDA clears first gene-edited pig kidney transplants in humans
In a significant development for organ transplantation, two U.S. biotechnology companies, United Therapeutics and ...
Insurer Denies Access To Drugs Granted Accelerated Approval By FDA
Going forward, we may see more instances in which insurers deny or (temporarily) severely restrict coverage of accelerated ...