August 6th 2025
The expanded label of tocilizumab-anoh now includes treatment for patients aged 2 years and older with cytokine release syndrome (CRS).
June 26th 2025
New phase 3 data support marstacimab’s efficacy and safety in treating hemophilia A or B with inhibitors, expanding its potential use.
June 16th 2025
Though the decision will not meet the June 17, 2025, target date, the federal agency anticipates a decision within approximately 4 weeks.
June 9th 2025
The combination therapy yielded boosted treatment benefits of navepegritide, including improvement in mean ACH Z-score and mean annualized growth.
June 2nd 2025
With the new drug application accepted with priority review, the FDA has assigned a date of November 20, 2025, to complete its review for potential approval.