Omisirge

omidubicel-onlv

Approval

ApplicationBLA 125738

Approval dateApr 17, 2023

Approval year2023

SponsorGamida Cell Ltd

FDA-approved use

For the treatment of:Adults and pediatric patients 12 years and older with hematologic malignancies who are planned for umbilical cord blood transplantation following myeloablative conditioning to reduce the time to neutrophil recovery and the incidence of infection.Adults and pediatric patients 6 years and older with severe aplastic anemia (SAA) following reduced intensity conditioning

Approval package

Query with Claude

The fda-analyst skill answers natural-language questions about this approval by fetching the relevant FDA review PDFs at query time.

git clone https://github.com/cbetz/trove
cp -r trove/skills/fda-analyst ~/.claude/skills/

Example prompts for Omisirge:

"What was the basis for Omisirge's approval — what trials, what endpoints?"
"What adverse events did the FDA flag in the Omisirge medical review?"
"What regulatory pathway did Omisirge use — priority review, breakthrough, accelerated approval?"