Regenecyte

HPC, Cord Blood

Approval

ApplicationBLA 125764

Approval dateNov 20, 2024

Approval year2024

SponsorStemCyte, Inc

FDA-approved use

For use in unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment

Approval package

↗ Drugs@FDA: full approval-package overview (every PDF the FDA released)
↗ FDA-approved label (PDF)

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 Regenecyte:

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