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Sibeprenlimab inches closer to approval www.hcplive.com/view/fda-acc... feat @brendonneuen.bsky.social Phase 3 RCT next week at #ERA25 (& some journal?)
May 29, 2025
With the priority review acceptance of the Biologics License Application, the FDA has assigned a PDUFA target action date of November 28, 2025.
www.hcplive.com
FDA Accepts, Grants Priority Review to Sibeprenlimab BLA for IgA Nephropathy
Swapnil Hiremath 🍁🇨🇦