The FDA has had a busy December 2025, with several notable new drug approvals. Eli Lilly’s Zepbound became the first FDA-approved medicine for chronic sleep apnea. Meanwhile, drugs for rare diseases were also given the go-ahead, including a treatment by Ionis Pharmaceuticals for a rare metabolic disorder and Humacyte’s bioengineered blood vessel for trauma patients. Finally, the FDA approval was granted to the first cell therapy from mesenchymal stromal cells by Mesoblast for graft versus host disease.
HHS Proposes Major HIPAA Cybersecurity Rule Changes
The U.S. Department of Health and Human Services has issued a Notice of Proposed Rulemaking to amend the Health Insurance Portability and Accountability Act’s Security
