EMA
The European Medicines Agency wants to develop a structured framework for non-clinical proof-of-concept studies in pediatric oncology.
The European Medicines Agency has requested updated safety warnings for Ixchiq’s product information after a case of aseptic meningitis was reported in a healthy young adult.
Strengthening the European Medicines Agency’s capacity to analyze clinical and non‑clinical raw data, expanding real-world evidence infrastructure, and boosting AI literacy across the EU regulatory network all feature prominently in a new 2026–2028 workplan.
The European Medicines Agency’s review of its stepwise pediatric investigation plan pilot, which allows sponsors in justified cases to finalize core study details later in development, found that the approach was both feasible and valuable in supporting complex pediatric drug development programs.
US FDA
Payroll costs in the prescription drug user fee program increased in fiscal year 2025 despite the reduction-in-force and voluntary departures, which could impact industry efforts to reduce the annual charges.
Pink Sheet editors discuss the impact of a federal judge’s decision that the recent ACIP membership turnover and vaccine schedule changes likely violated statutes, as well as the FDA’s look at new opioid disposal requirements.
The US FDA’s Rare Disease Hub is becoming more concrete, with dedicated 2026 funding and momentum for a more substantial user-fee allocation going forward.
Now that CBER Director Vinay Prasad is leaving the FDA, Regenxbio's CEO is unsure a fast track pathway agreement will remain in place for its Duchenne muscular dystrophy gene therapy, RGX-202.