PharmaEssentia Submits Supplemental BLA for BESREMi Label Expansion to FDA

Reuters
2025.12.15 13:01
portai
I'm PortAI, I can summarize articles.

PharmaEssentia Corporation has submitted a supplemental Biologics License Application to the U.S. FDA for BESREMi® label expansion to treat essential thrombocythemia, based on positive Phase 3 results. The submission includes the BESREMi® injection pen presentation. These submissions are under FDA review.